Clinical trial: NCT02798536
Section: Alternatives
Subsections: Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?|What Other Choices Do I Have If I Do Not Take Part In This Study?|What Other Choices Do I Have If I Do Not Take Part In This Study?|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?|What Other Choices Do I Have If I Do Not Take Part In This Study?|What Other Choices Do I Have If I Do Not Take Part In This Study?

The aim of this study is to find a safe dose for this experimental treatment. We do not know if you will receive personal, medical benefit from taking part in this study. These potential benefits could include shrinking of your tumor or lessening of your symptoms, such as pain, that are caused by the cancer. Because there is not much information about the drug's effect on your cancer, we do  
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not know if you will benefit from taking part in this study, although the knowledge gained from this study may help others in the future who have cancer.

The aim of this study is to find a safe dose for this experimental treatment. We do not know if you will receive personal, medical benefit from taking part in this study. These potential benefits could include shrinking of your tumor or lessening of your symptoms, such as pain, that are caused by the cancer. Because there is not much information about the drug's effect on your cancer, we do not know if you will benefit from taking part in this study, although the knowledge gained from this study may help others in the future who have cancer.  
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Instead of being in this study, you have these options:
Getting treatment or care for your cancer without being in a study  
Taking part in another study Getting comfort care, also called palliative care. This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly. Instead, it tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.
Please talk to your doctor about these and other options.

Instead of being in this study, you have these options:
Getting treatment or care for your cancer without being in a study  
Taking part in another study Getting comfort care, also called palliative care. This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly. Instead, it tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.
Please talk to your doctor about these and other options.

The aim of this study is to find a safe dose for this experimental treatment. We do not know if you will receive personal, medical benefit from taking part in this study. These potential benefits could include shrinking of your tumor or lessening of your symptoms, such as pain, that are caused by the cancer. Because there is not much information about the drug's effect on your cancer, we do  
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not know if you will benefit from taking part in this study, although the knowledge gained from this study may help others in the future who have cancer.

The aim of this study is to find a safe dose for this experimental treatment. We do not know if you will receive personal, medical benefit from taking part in this study. These potential benefits could include shrinking of your tumor or lessening of your symptoms, such as pain, that are caused by the cancer. Because there is not much information about the drug's effect on your cancer, we do not know if you will benefit from taking part in this study, although the knowledge gained from this study may help others in the future who have cancer.  
File in Section 4: Protocol Consent (2) Version Date: 03/01/2020  
Page 10 **of** 16  
CC ICF template v. 09.27.19

Instead of being in this study, you have these options:
Getting treatment or care for your cancer without being in a study  
Taking part in another study Getting comfort care, also called palliative care. This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly. Instead, it tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.
Please talk to your doctor about these and other options.

Instead of being in this study, you have these options:
Getting treatment or care for your cancer without being in a study  
Taking part in another study Getting comfort care, also called palliative care. This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly. Instead, it tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.
Please talk to your doctor about these and other options.
Clinical trial: NCT02798536
Section: Confidentiality
Subsections: Confidentiality Protections Provided In This Study Will Your Medical Information Be Kept Private?|Confidentiality Protections Provided In This Study Will Your Medical Information Be Kept Private?|Certificate Of Confidentiality|Certificate Of Confidentiality|Privacy Act|Privacy Act|Confidentiality Protections Provided In This Study Will Your Medical Information Be Kept Private?|Confidentiality Protections Provided In This Study Will Your Medical Information Be Kept Private?|Certificate Of Confidentiality|Certificate Of Confidentiality|Privacy Act|Privacy Act

We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:
The NIH and other government agencies, like the Food and Drug Administration (FDA), which are involved in keeping research safe for people. National Institutes of Health Intramural Institutional Review Board Qualified representatives from Celgene, the pharmaceutical company who produces nabpaclitaxel When results of an NIH research study are reported in medical journals or at scientific meetings, the people who take part are not named and identified. In most cases, the NIH will not release any information about your research involvement without your written permission. However, if you sign a release of information form, for example, for an insurance company, the NIH will give the insurance company information from your medical record. This information might affect (either favorably or unfavorably) the willingness of the insurance company to sell you insurance. If we share your specimens or data with other researchers, in most circumstances we will remove your identifiers before sharing your specimens or data. You should be aware that there is a slight possibility that someone could figure out the information is about you. Further, the information collected for this study is protected by NIH under a Certificate of Confidentiality and the Privacy Act.

We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:
The NIH and other government agencies, like the Food and Drug Administration (FDA), which are involved in keeping research safe for people. National Institutes of Health Intramural Institutional Review Board Qualified representatives from Celgene, the pharmaceutical company who produces nabpaclitaxel When results of an NIH research study are reported in medical journals or at scientific meetings, the people who take part are not named and identified. In most cases, the NIH will not release any information about your research involvement without your written permission. However, if you sign a release of information form, for example, for an insurance company, the NIH will give the insurance company information from your medical record. This information might affect (either favorably or unfavorably) the willingness of the insurance company to sell you insurance. If we share your specimens or data with other researchers, in most circumstances we will remove your identifiers before sharing your specimens or data. You should be aware that there is a slight possibility that someone could figure out the information is about you. Further, the information collected for this study is protected by NIH under a Certificate of Confidentiality and the Privacy Act.

To help us protect your privacy, the NIH Intramural Program has received a Certificate of Confidentiality (Certificate). With this certificate, researchers may not release or use data or information about you except in certain circumstances. NIH researchers must not share information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if requested by a court. The Certificate does not protect your information when it:
1. is disclosed to people connected with the research, for example, information may be used for auditing or program evaluation internally by the NIH; or 2. is required to be disclosed by Federal, State, or local laws, for example, when information must be disclosed to meet the legal requirements of the federal Food and Drug Administration (FDA);
3. is for other research; 4. is disclosed with your consent.  
The Certificate does not prevent you from voluntarily releasing information about yourself or your involvement in this research. The Certificate will not be used to prevent disclosure to state or local authorities of harm to self or others including, for example, child abuse and neglect, and by signing below you consent to those disclosures. Other permissions for release may be made by signing NIH forms, such as the Notice and Acknowledgement of Information Practices consent.

To help us protect your privacy, the NIH Intramural Program has received a Certificate of Confidentiality (Certificate). With this certificate, researchers may not release or use data or information about you except in certain circumstances. NIH researchers must not share information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if requested by a court. The Certificate does not protect your information when it:
1. is disclosed to people connected with the research, for example, information may be used for auditing or program evaluation internally by the NIH; or 2. is required to be disclosed by Federal, State, or local laws, for example, when information must be disclosed to meet the legal requirements of the federal Food and Drug Administration (FDA);
3. is for other research; 4. is disclosed with your consent.  
The Certificate does not prevent you from voluntarily releasing information about yourself or your involvement in this research. The Certificate will not be used to prevent disclosure to state or local authorities of harm to self or others including, for example, child abuse and neglect, and by signing below you consent to those disclosures. Other permissions for release may be made by signing NIH forms, such as the Notice and Acknowledgement of Information Practices consent.

The Federal Privacy Act generally protects the confidentiality of your NIH medical records we collect under the authority of the Public Health Service Act. In some cases, the Privacy Act protections differ from the Certificate of Confidentiality. For example, sometimes the Privacy Act allows release of information from your medical record without your permission, for example, if it is requested by Congress. Information may also be released for certain research purposes with due consideration and protection, to those engaged by the agency for research purposes, to certain federal and state agencies, for HIV partner notification, for infectious disease or abuse or neglect reporting, to tumor registries, for quality assessment and medical audits, or when the NIH is involved in a lawsuit. However, NIH will only release information from your medical record if it is permitted by both the Certificate of Confidentiality and the Privacy Act.

The Federal Privacy Act generally protects the confidentiality of your NIH medical records we collect under the authority of the Public Health Service Act. In some cases, the Privacy Act protections differ from the Certificate of Confidentiality. For example, sometimes the Privacy Act allows release of information from your medical record without your permission, for example, if it is requested by Congress. Information may also be released for certain research purposes with due consideration and protection, to those engaged by the agency for research purposes, to certain federal and state agencies, for HIV partner notification, for infectious disease or abuse or neglect reporting, to tumor registries, for quality assessment and medical audits, or when the NIH is involved in a lawsuit. However, NIH will only release information from your medical record if it is permitted by both the Certificate of Confidentiality and the Privacy Act.

We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:
The NIH and other government agencies, like the Food and Drug Administration (FDA), which are involved in keeping research safe for people. National Institutes of Health Intramural Institutional Review Board Qualified representatives from Celgene, the pharmaceutical company who produces nabpaclitaxel When results of an NIH research study are reported in medical journals or at scientific meetings, the people who take part are not named and identified. In most cases, the NIH will not release any information about your research involvement without your written permission. However, if you sign a release of information form, for example, for an insurance company, the NIH will give the insurance company information from your medical record. This information might affect (either favorably or unfavorably) the willingness of the insurance company to sell you insurance. If we share your specimens or data with other researchers, in most circumstances we will remove your identifiers before sharing your specimens or data. You should be aware that there is a slight possibility that someone could figure out the information is about you. Further, the information collected for this study is protected by NIH under a Certificate of Confidentiality and the Privacy Act.

We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:
The NIH and other government agencies, like the Food and Drug Administration (FDA), which are involved in keeping research safe for people. National Institutes of Health Intramural Institutional Review Board Qualified representatives from Celgene, the pharmaceutical company who produces nabpaclitaxel When results of an NIH research study are reported in medical journals or at scientific meetings, the people who take part are not named and identified. In most cases, the NIH will not release any information about your research involvement without your written permission. However, if you sign a release of information form, for example, for an insurance company, the NIH will give the insurance company information from your medical record. This information might affect (either favorably or unfavorably) the willingness of the insurance company to sell you insurance. If we share your specimens or data with other researchers, in most circumstances we will remove your identifiers before sharing your specimens or data. You should be aware that there is a slight possibility that someone could figure out the information is about you. Further, the information collected for this study is protected by NIH under a Certificate of Confidentiality and the Privacy Act.

To help us protect your privacy, the NIH Intramural Program has received a Certificate of Confidentiality (Certificate). With this certificate, researchers may not release or use data or information about you except in certain circumstances. NIH researchers must not share information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if requested by a court. The Certificate does not protect your information when it:
1. is disclosed to people connected with the research, for example, information may be used for auditing or program evaluation internally by the NIH; or 2. is required to be disclosed by Federal, State, or local laws, for example, when information must be disclosed to meet the legal requirements of the federal Food and Drug Administration (FDA);
3. is for other research; 4. is disclosed with your consent.  
The Certificate does not prevent you from voluntarily releasing information about yourself or your involvement in this research. The Certificate will not be used to prevent disclosure to state or local authorities of harm to self or others including, for example, child abuse and neglect, and by signing below you consent to those disclosures. Other permissions for release may be made by signing NIH forms, such as the Notice and Acknowledgement of Information Practices consent.

To help us protect your privacy, the NIH Intramural Program has received a Certificate of Confidentiality (Certificate). With this certificate, researchers may not release or use data or information about you except in certain circumstances. NIH researchers must not share information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if requested by a court. The Certificate does not protect your information when it:
1. is disclosed to people connected with the research, for example, information may be used for auditing or program evaluation internally by the NIH; or 2. is required to be disclosed by Federal, State, or local laws, for example, when information must be disclosed to meet the legal requirements of the federal Food and Drug Administration (FDA);
3. is for other research; 4. is disclosed with your consent.  
The Certificate does not prevent you from voluntarily releasing information about yourself or your involvement in this research. The Certificate will not be used to prevent disclosure to state or local authorities of harm to self or others including, for example, child abuse and neglect, and by signing below you consent to those disclosures. Other permissions for release may be made by signing NIH forms, such as the Notice and Acknowledgement of Information Practices consent.

The Federal Privacy Act generally protects the confidentiality of your NIH medical records we collect under the authority of the Public Health Service Act. In some cases, the Privacy Act protections differ from the Certificate of Confidentiality. For example, sometimes the Privacy Act allows release of information from your medical record without your permission, for example, if it is requested by Congress. Information may also be released for certain research purposes with due consideration and protection, to those engaged by the agency for research purposes, to certain federal and state agencies, for HIV partner notification, for infectious disease or abuse or neglect reporting, to tumor registries, for quality assessment and medical audits, or when the NIH is involved in a lawsuit. However, NIH will only release information from your medical record if it is permitted by both the Certificate of Confidentiality and the Privacy Act.

The Federal Privacy Act generally protects the confidentiality of your NIH medical records we collect under the authority of the Public Health Service Act. In some cases, the Privacy Act protections differ from the Certificate of Confidentiality. For example, sometimes the Privacy Act allows release of information from your medical record without your permission, for example, if it is requested by Congress. Information may also be released for certain research purposes with due consideration and protection, to those engaged by the agency for research purposes, to certain federal and state agencies, for HIV partner notification, for infectious disease or abuse or neglect reporting, to tumor registries, for quality assessment and medical audits, or when the NIH is involved in a lawsuit. However, NIH will only release information from your medical record if it is permitted by both the Certificate of Confidentiality and the Privacy Act.
Clinical trial: NCT02798536
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Or Discomforts Of Participation Risks And Possible Undesirable Effects Of Lmb-100|The Most Important Symptoms You Need To Report To Your Doctor Immediately Are:|The Most Important Symptoms You Need To Report To Your Doctor Immediately Are:|Risks From Pre-Medications Acetaminophen|Risks From Pre-Medications Acetaminophen|Ranitidine:|Ranitidine:|Risks From Study Procedures|Risks From Study Procedures|- **Vasectomy** Risks Or Discomforts Of Participation Risks And Possible Undesirable Effects Of Lmb-100|There May Also Be Pain And Swelling At The Infusion Site.|The Most Important Symptoms You Need To Report To Your Doctor Immediately Are:|The Most Important Symptoms You Need To Report To Your Doctor Immediately Are:|Risks Of Nab**-Paclitaxel** Very Common, Some May Be Serious|Very Common, Some May Be Serious|Common, Some May Be Serious In 100 People Receiving Nab-Paclitaxel, From 1 To 9 May Have:|Common, Some May Be Serious|Uncommon, Some May Be Serious|Elderly|Birth Defects|Risks From Pre-Medications Acetaminophen|Risks From Pre-Medications Acetaminophen|Ranitidine:|Ranitidine:|Dexamethasone:|Risks From Study Procedures|Risks From Study Procedures|Blood Draws

Prior to this study LMB-100 has only been given to 15 subjects; therefore, we do not know all of the possible side effects. However, below is a list of the most common and most serious side effects occurring on the earlier study, some occurring at higher doses than will be used in this study. The most common side effects (some were serious) were:
Low levels of the blood protein albumin which may lead to swelling, muscle weakness or loss of appetite  
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Tiredness Swelling of the arms and legs Nausea Fever Decreased appetite Shortness of breath Pain in muscles Less common, but serious side effects included:
Fluid in the organs which may cause low blood pressure, shortness of breath, swelling of ankles Abnormal heartbeat Reactions during or following the infusion of the drug which may cause fever, chills, rash or low blood pressure Pain in joints Kidney damage which may cause swelling, may require dialysis Other possible side effects Other possible side effects discussed below are based on side effects that occurred when testing a similar agent, SS1P and in animal studies of LMB-100. It is possible that there may be other unexpected side-effects that occur in addition to those listed below. LMB-100 may cause inflammation to membranes causing chest pain, shortness of breath, low blood pressure, and heart failure. In animals, some mild kidney toxicity was seen, characterized by increased enzymes and protein in the urine. This will be checked for with regular blood and urine tests. As with other drugs similar to LMB-100, there is a chance that the drug could cause the body to produce an unwanted response called 'Anti-drug antibodies' (ADAs). These might not cause problems however there is a chance they could lead to a severe anti-drug response in the body.  
ADA levels will be measured during the study to monitor any changes.  
There may also be pain and swelling at the infusion site. It is important that you contact your doctor as soon as you experience any side effects whether you think the treatment has caused them or not. You must also tell your doctor if you have started any new medication or had a change to your existing medication. This includes medications available without a prescription (over the counter) and alternative medicines. If you have any questions or concerns about any of the information provided above, about the possible side effects of treatment, or the possible consequences of treatment for those side effects, please ask the principal investigator or the research staff for more information.  
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o **possible infusion or allergic reactions (symptoms that start during or within a few**
hours of the infusion, e.g., wheezing, tightness in the throat or chest, rash, and facial swelling)
o **chest pain** o **shortness of breath**
o **palpitations (fast heart beat)**
o **bleeding and high fever** o **impaired brain function (e.g., dizziness, blurred vision, confusion)**
If you experience any severe or dangerous side effect, you should:

o **possible infusion or allergic reactions (symptoms that start during or within a few**
hours of the infusion, e.g., wheezing, tightness in the throat or chest, rash, and facial swelling)
o **chest pain** o **shortness of breath**
o **palpitations (fast heart beat)**
o **bleeding and high fever** o **impaired brain function (e.g., dizziness, blurred vision, confusion)**
If you experience any severe or dangerous side effect, you should:
1. Seek professional medical help immediately. 2. Call your study doctor. 3. If necessary, go to the nearest emergency room.

Acetaminophen is considered to be safe and effective in the recommended doses. However, when taken incorrectly acetaminophen can cause liver damage. Your risk of liver damage may be increased if you drink more than three alcoholic drinks every day, take more than the recommended dose (overdose), or if you take any additional drugs that also contain acetaminophen at the same time. Diphenhydramine Drowsiness, dizziness, constipation, stomach upset, blurred vision, or dry mouth/nose/throat may occur when taking diphenhydramine.

Acetaminophen is considered to be safe and effective in the recommended doses. However, when taken incorrectly acetaminophen can cause liver damage. Your risk of liver damage may be increased if you drink more than three alcoholic drinks every day, take more than the recommended dose (overdose), or if you take any additional drugs that also contain acetaminophen at the same time. Diphenhydramine Drowsiness, dizziness, constipation, stomach upset, blurred vision, or dry mouth/nose/throat may occur when taking diphenhydramine.

It can cause constipation, diarrhea, headache, nausea or upset stomach. Rare serious side effects include severe allergic reaction with rash, hives, itching, difficulty breathing; confusion, dark urine, depression, fast or slow heartbeat, unusual bruising or bleeding, yellowing of the eyes or skin (indicating liver damage). Dexamethasone: Stomach upset, headache, dizziness, changes in your period, trouble sleeping, increased appetite, or weight gain may occur. Rarely patients using dexamethasone have experienced increased infection, bone/joint pain, thirst, increased urination, irregular heartbeat, eye pain, vision problems, black stools, vomit that looks like coffee grounds, puffy face, swelling of the feet and ankles, pain/redness/swelling of the arms or legs, tiredness, mood changes, unusual hair/skin growth, muscle cramps, weakness, easy bruising/bleeding, slow wound healing, thinning skin and seizures.

It can cause constipation, diarrhea, headache, nausea or upset stomach. Rare serious side effects include severe allergic reaction with rash, hives, itching, difficulty breathing; confusion, dark urine, depression, fast or slow heartbeat, unusual bruising or bleeding, yellowing of the eyes or skin (indicating liver damage).

The following study procedures and treatments may have risks and cause discomfort while you participate on this study: Blood draws There is the risk of slight pain, bruising or infection when your blood is drawn. Drawing blood may cause some people to faint. ECGs The glue used to keep the electrodes in place during the ECG may irritate your skin and cause redness. Tumor Biopsies and Effusions Tumor biopsies and tumor effusions: local anesthesia of the skin will be given prior to any tumor biopsy or effusion collection, in order to prevent painful sensations. However, you may still experience pain or discomfort at the biopsy site. Irritation, redness, swelling and/or bleeding may also occur. There is a risk of abnormal healing, fever, infection or of an allergic reaction to the anesthetic agent used to anesthetize the skin at the biopsy site. Once the sample has been obtained, a stitch may be used to close the wound and facilitate healing. In some cases, we may use CT scans to help guide us during your biopsy. This introduces the added risk of research radiation. This research study may involve exposure to radiation from up to 2 CT guided tumor biopsies. **This radiation exposure is not required for your medical care and** is for research purposes only. The amount of radiation you will receive in this study is 1.5 rem which is below the guideline of 5 rem per year allowed for research subjects by the NIH Radiation Safety Committee. The average person in the United States receives a radiation exposure of 0.3 rem per year from natural sources, such as the sun, outer space, and the earth's air and soil. If you would like more information about radiation, please ask the investigator for a copy of the pamphlet, An Introduction to Radiation for NIH Research Subjects. While there is no direct evidence that the amount of exposure received from participating in this study is harmful, there is indirect evidence it may not be completely safe. There may be a very slight increase in the risk of cancer.  
Please tell your doctor if you have had any radiation exposure in the past year, either from other research studies or from medical tests or care, so we can make sure that you will not receive too much radiation. Radiation exposure includes x-rays taken in radiology departments, cardiac catheterization, and fluoroscopy as well as nuclear medicine scans in which radioactive materials were injected into your body.

The following study procedures and treatments may have risks and cause discomfort while you participate on this study:  
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Prior to this study LMB-100 has only been given to 15 subjects; therefore, we do not know all of the possible side effects. However, below is a list of the most common and most serious side effects occurring on the earlier study, some occurring at higher doses than will be used in this study. The most common side effects (some were serious) were:
Low levels of the blood protein albumin which may lead to swelling, muscle weakness or loss of appetite Tiredness Swelling of the arms and legs Nausea Fever Decreased appetite Shortness of breath Pain in muscles Less common, but serious side effects included:
Fluid in the organs which may cause low blood pressure, shortness of breath, swelling of ankles Abnormal heartbeat Reactions during or following the infusion of the drug which may cause fever, chills, rash or low blood pressure Pain in joints Kidney damage which may cause swelling, may require dialysis Other possible side effects Other possible side effects discussed below are based on side effects that occurred when testing a similar agent, SS1P and in animal studies of LMB-100. It is possible that there may be other unexpected side-effects that occur in addition to those listed below. LMB-100 may cause inflammation to membranes causing chest pain, shortness of breath, low blood pressure, and heart failure. In animals, some mild kidney toxicity was seen, characterized by increased enzymes and protein in the urine. This will be checked for with regular blood and urine tests. As with other drugs similar to LMB-100, there is a chance that the drug could cause the body to produce an unwanted response called 'Anti-drug antibodies' (ADAs). These might not cause problems however there is a chance they could lead to a severe anti-drug response in the body. ADA levels will be measured during the study to monitor any changes.  
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It is important that you contact your doctor as soon as you experience any side effects whether you think the treatment has caused them or not. You must also tell your doctor if you have started any new medication or had a change to your existing medication. This includes medications available without a prescription (over the counter) and alternative medicines. If you have any questions or concerns about any of the information provided above, about the possible side effects of treatment, or the possible consequences of treatment for those side effects, please ask the principal investigator or the research staff for more information.

o **possible infusion or allergic reactions (symptoms that start during or within a few**
hours of the infusion, e.g., wheezing, tightness in the throat or chest, rash, and facial swelling)
o **chest pain** o **shortness of breath**
o **palpitations (fast heart beat)**
o **bleeding and high fever** o **impaired brain function (e.g., dizziness, blurred vision, confusion)**
If you experience any severe or dangerous side effect, you should:

o **possible infusion or allergic reactions (symptoms that start during or within a few**
hours of the infusion, e.g., wheezing, tightness in the throat or chest, rash, and facial swelling)
o **chest pain** o **shortness of breath**
o **palpitations (fast heart beat)**
o **bleeding and high fever** o **impaired brain function (e.g., dizziness, blurred vision, confusion)**
If you experience any severe or dangerous side effect, you should:
1. Seek professional medical help immediately. 2. Call your study doctor. 3. If necessary, go to the nearest emergency room.

In 100 people receiving nab-paclitaxel, more than 9 and up to 100 may have:  
anemia (a decrease in the number of red blood cells which may make you feel weak or tired) low number of white blood cells with or without fever (that may make it easier get infections) a decrease in the number platelets, the cells that help your blood to clot (which may lead to unusual bleeding or bruising under the skin)  
constipation  
diarrhea  
nausea  
vomiting  
pain (including muscle, joints, bone, and chest pain) swelling caused by fluid held in the tissues, especially of the ankles, feet or fingers fever  
chills  
decreased appetite  
change in taste  
weight loss difficulty sleeping depression cough  
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In 100 people receiving nab-paclitaxel, more than 9 and up to 100 may have:
stomach pain pain, swelling or sores on the inside of the mouth neuropathy, a disorder of the nerves which can cause tingling or numbness, with weakness, or decreased sensation or movement dizziness headache feeling tired or weak hair loss rash, possibly red, bumpy or generalized itchiness changes in nails, including discoloration or separation from nailbed abnormal liver function test results dehydration (loss of water and minerals in the body)
nose bleed decreased potassium levels in the blood

| a severe reduction of red or white blood  cells and platelets (at nearly the same  time) which can cause weakness,  bruising, or make infections more likely  infections, including pneumonia or of  the lung, mouth, gallbladder, urinary  tract, nail, or hair follicle  a very severe infection of the blood  which may include a decrease in blood  pressure  inflammation of the lung passages  thickening, inflammation or scarring in  the lungs which may cause  breathlessness, cough  inflammation of the bowel causing  abdominal pain or diarrhea  blockage of the intestine  trouble swallowing  indigestion or upset stomach  abnormal chemistry or electrolyte blood  test results  abnormal kidney function test results   | nasal congestion  mouth or throat pain  dry mouth, nose, and throat  coughing up blood or bloody sputum  blood clot in the lungs or in deep vein  fluid in the chest cavity  red or flushed skin  dry skin  hand-foot syndrome, involving  reddening, swelling, numbness and  peeling of palms and soles of feet  high blood pressure low blood pressure  a decrease in the heart's ability to pump  blood to all parts of the body and  possibly heart failure  faster heart beat  watery eyes  changes in vision or blurry vision  infusion site reactions (described as  discomfort, bleeding or  bruising/swelling at the needle site, and   |
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| PATIENT IDENTIFICATION                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | Consent to Participate in a Clinical Research Study NIH-2977 (4-17) File in Section 4: Protocol Consent (2) Version Date: 03/01/2020 Page 7 of 16                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
| CC ICF template v. 09.27.19                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |

In 100 people receiving nab-paclitaxel, from 1 to 9 may have:  
| acute kidney failure  blood in the urine  lack of muscle coordination  muscle weakness  anxiety   |
|---------------------------------------------------------------------------------------------------|

| in some instances infection or leaking  of IV fluid outside of blood vessel into  the surrounding tissue)  localized swelling due to buildup of  lymph fluid   |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|  
In 100 people receiving nab-paclitaxel, fewer than 1 may have:
Additional side effects observed during post-marketing surveillance of nab**-paclitaxel, not** otherwise noted above include:
- **lack of movement in the vocal cords with possible voice changes**  
- **skin sensitivity to sunlight**
- **potentially life threatening allergic reaction [may include skin rash with skin blistering]**
- **skin or tissue damage from prior radiation therapy can become damaged again, when a**
person receives chemotherapy after having had radiation therapy. This is referred to as radiation recall and may involve redness, peeling, pain, and swelling. Skin changes  
 have been noted to range from mild redness to tissue death. Radiation recall

In subjects 65 years old with metastatic breast cancer who received nab-**paclitaxel monotherapy,**
a higher incidence of nose bleed, diarrhea, dehydration (loss of water and minerals in the body),
feeling tired or weak and swelling caused by fluid held in the tissues, especially of the ankles, feet or fingers has been reported.

Nab**-paclitaxel may cause serious birth defects. Please refer to the section about birth control for** more information on how to protect yourself if you are a female who is able to get pregnant or a male patient who has a partner who is able to get pregnant. Nab**-paclitaxel can cause irreversible**
infertility in male patients. Male patients should seek advice on conservation of sperm prior to treatment.

Acetaminophen is considered to be safe and effective in the recommended doses. However, when taken incorrectly acetaminophen can cause liver damage. Your risk of liver damage may be increased if you drink more than three alcoholic drinks every day, take more than the recommended dose (overdose), or if you take any additional drugs that also contain acetaminophen at the same time. Diphenhydramine Drowsiness, dizziness, constipation, stomach upset, blurred vision, or dry mouth/nose/throat may occur when taking diphenhydramine.

Acetaminophen is considered to be safe and effective in the recommended doses. However, when taken incorrectly acetaminophen can cause liver damage. Your risk of liver damage may be increased if you drink more than three alcoholic drinks every day, take more than the recommended dose (overdose), or if you take any additional drugs that also contain acetaminophen at the same time. Diphenhydramine Drowsiness, dizziness, constipation, stomach upset, blurred vision, or dry mouth/nose/throat may occur when taking diphenhydramine.

It can cause constipation, diarrhea, headache, nausea or upset stomach. Rare serious side effects include severe allergic reaction with rash, hives, itching, difficulty breathing; confusion, dark urine, depression, fast or slow heartbeat, unusual bruising or bleeding, yellowing of the eyes or skin (indicating liver damage). Dexamethasone: Stomach upset, headache, dizziness, changes in your period, trouble sleeping, increased appetite, or weight gain may occur. Rarely patients using dexamethasone have experienced increased infection, bone/joint pain, thirst, increased urination, irregular heartbeat, eye pain, vision problems, black stools, vomit that looks like coffee grounds, puffy face, swelling of the feet and ankles, pain/redness/swelling of the arms or legs, tiredness, mood changes, unusual hair/skin growth, muscle cramps, weakness, easy bruising/bleeding, slow wound healing, thinning skin and seizures.

It can cause constipation, diarrhea, headache, nausea or upset stomach. Rare serious side effects include severe allergic reaction with rash, hives, itching, difficulty breathing; confusion, dark urine, depression, fast or slow heartbeat, unusual bruising or bleeding, yellowing of the eyes or skin (indicating liver damage).

Stomach upset, headache, dizziness, changes in your period, trouble sleeping, increased appetite, or weight gain may occur. Rarely patients using dexamethasone have experienced increased infection, bone/joint pain, thirst, increased urination, irregular heartbeat, eye pain, vision problems, black stools, vomit that looks like coffee grounds, puffy face, swelling of the feet and ankles, pain/redness/swelling of the arms or legs, tiredness, mood changes, unusual hair/skin growth, muscle cramps, weakness, easy bruising/bleeding, slow wound healing, thinning skin and seizures.

The following study procedures and treatments may have risks and cause discomfort while you participate on this study: Blood draws There is the risk of slight pain, bruising or infection when your blood is drawn. Drawing blood may cause some people to faint. ECGs The glue used to keep the electrodes in place during the ECG may irritate your skin and cause redness. Tumor Biopsies and Effusions Tumor biopsies and tumor effusions: local anesthesia of the skin will be given prior to any tumor biopsy or effusion collection, in order to prevent painful sensations. However, you may still experience pain or discomfort at the biopsy site. Irritation, redness, swelling and/or bleeding may also occur. There is a risk of abnormal healing, fever, infection or of an allergic reaction to the anesthetic agent used to anesthetize the skin at the biopsy site. Once the sample has been obtained, a stitch may be used to close the wound and facilitate healing. In some cases, we may use CT scans to help guide us during your biopsy. This introduces the added risk of research radiation. This research study may involve exposure to radiation from up to 2 CT guided tumor biopsies. **This radiation exposure is not required for your medical care and** is for research purposes only. The amount of radiation you will receive in this study is 1.5 rem which is below the guideline of 5 rem per year allowed for research subjects by the NIH Radiation Safety Committee. The average person in the United States receives a radiation exposure of 0.3 rem per year from natural sources, such as the sun, outer space, and the earth's air and soil. If you would like more information about radiation, please ask the investigator for a copy of the pamphlet, An Introduction to Radiation for NIH Research Subjects. While there is no direct evidence that the amount of exposure received from participating in this study is harmful, there is indirect evidence it may not be completely safe. There may be a very slight increase in the risk of cancer.  
Please tell your doctor if you have had any radiation exposure in the past year, either from other research studies or from medical tests or care, so we can make sure that you will not receive too much radiation. Radiation exposure includes x-rays taken in radiology departments, cardiac catheterization, and fluoroscopy as well as nuclear medicine scans in which radioactive materials were injected into your body.

The following study procedures and treatments may have risks and cause discomfort while you participate on this study:  
File in Section 4: Protocol Consent (2) Version Date: 03/01/2020  
Page 9 **of** 16  
CC ICF template v. 09.27.19

There is the risk of slight pain, bruising or infection when your blood is drawn. Drawing blood may cause some people to faint. ECGs The glue used to keep the electrodes in place during the ECG may irritate your skin and cause redness. Tumor Biopsies and Effusions Tumor biopsies and tumor effusions: local anesthesia of the skin will be given prior to any tumor biopsy or effusion collection, in order to prevent painful sensations. However, you may still experience pain or discomfort at the biopsy site. Irritation, redness, swelling and/or bleeding may also occur. There is a risk of abnormal healing, fever, infection or of an allergic reaction to the anesthetic agent used to anesthetize the skin at the biopsy site. Once the sample has been obtained, a stitch may be used to close the wound and facilitate healing. In some cases, we may use CT scans to help guide us during your biopsy. This introduces the added risk of research radiation. This research study may involve exposure to radiation from up to 2 CT guided tumor biopsies. **This radiation exposure is not required for your medical care and** is for research purposes only. The amount of radiation you will receive in this study is 1.5 rem which is below the guideline of 5 rem per year allowed for research subjects by the NIH Radiation Safety Committee. The average person in the United States receives a radiation exposure of 0.3 rem per year from natural sources, such as the sun, outer space, and the earth's air and soil. If you would like more information about radiation, please ask the investigator for a copy of the pamphlet, An Introduction to Radiation for NIH Research Subjects.  
While there is no direct evidence that the amount of exposure received from participating in this study is harmful, there is indirect evidence it may not be completely safe. There may be a very slight increase in the risk of cancer. Please tell your doctor if you have had any radiation exposure in the past year, either from other research studies or from medical tests or care, so we can make sure that you will not receive too much radiation. Radiation exposure includes x-rays taken in radiology departments, cardiac catheterization, and fluoroscopy as well as nuclear medicine scans in which radioactive materials were injected into your body.
Clinical trial: NCT02798536
Section: Procedures
Subsections: What Will Happen If You Take Part In This Research Study? Before You Begin The Study|What Will Happen If You Take Part In This Research Study? Before You Begin The Study|During The Study|During The Study|When You Are Finished Taking The Drugs|When You Are Finished Taking The Drugs|What Will Happen If You Take Part In This Research Study? Before You Begin The Study|What Will Happen If You Take Part In This Research Study? Before You Begin The Study|During The Study|During The Study|When You Are Finished Taking The Drugs|When You Are Finished Taking The Drugs

Before beginning the study, you will need to undergo tests and/or procedures to help your doctor verify whether you can participate. This is called screening. Most of the exams, tests, and procedures you will have are part of the usual approach for your cancer. However, there are some extra procedures that you will need to have if you take part in this study. If you have already undergone some of these examinations very recently, your doctor may decide not to repeat them. Briefly, these tests, which are performed under a separate consent, include:
Confirmation of diagnosis (You must provide a sample tumor tissue for an evaluation from the NCI Laboratory of Pathology. The tissue may be from a previous surgery, biopsy or  
File in Section 4: Protocol Consent (1) Version Date: 03/01/2020  
Page 2 **of** 13  
CC ICF template v. 09.27.19  
collection from a tumor effusion (fluid around the tumor). If none is available, we will ask you to have a biopsy or a collection of effusion material to provide a fresh sample). Please see page 7, Tumor Biopsies and Effusions for a description of the procedure.  
Medical history and physical examination Routine blood and urine tests including pregnancy test in women who can have children. Pregnant women will not be allowed on study.  
Scans and x-rays Electrocardiogram (ECG) Echocardiogram Tests for viruses (hepatitis and HIV)

Before beginning the study, you will need to undergo tests and/or procedures to help your doctor verify whether you can participate. This is called screening. Most of the exams, tests, and procedures you will have are part of the usual approach for your cancer. However, there are some extra procedures that you will need to have if you take part in this study. If you have already undergone some of these examinations very recently, your doctor may decide not to repeat them. Briefly, these tests, which are performed under a separate consent, include:  
Confirmation of diagnosis (You must provide a sample tumor tissue for an evaluation by the NCI Laboratory of Pathology. The tissue may be from a previous surgery, biopsy or collection from a tumor effusion (fluid around the tumor). If none is available, we will ask you to have a biopsy or a collection of effusion material to provide a fresh sample). Please see page 10, Tumor Biopsies and Effusions for a description of the procedure.  
Medical history and physical examination Routine blood and urine tests including pregnancy test in women who can have children.  
Pregnant women will not be allowed on study.  
Scans and x-rays Electrocardiogram (ECG) Echocardiogram Tests for viruses (hepatitis and HIV)

Once it is determined that you are eligible and you have signed the consent for the study, you will receive IV infusions of LMB-100 as described above. Each infusion will last about 30 minutes, but it might take longer if your study doctor decides it is needed for your safety. You will be monitored for side effects for 2 hours after the first infusion, and for 30 minutes after all other infusions if no side effects occurred previously. We will give you standard pre-medications that include an antihistamine (such a Benadryl), acetaminophen (Tylenol), ranitidine (Zantac) and dexamethasone, a steroid to help prevent infusion related side effects. While you are taking study medication, we will perform a number of tests and examinations for safety and to test the effect of the study therapy. These include routine blood and urine tests that will be done 4 - 5 times per cycle, a chest X-ray on day 1 of each cycle, scans that will be performed approximately every 6 weeks, and ECGs that will be done just before each infusion. We will also perform tests for research studies to find out how your body handles the drug (PKs), the types of immune cells present in your disease, how your body reacts to the drug and how certain side effects of the LMB-100 might be caused. Most of the sampling for these research tests will be done before your first dose of study drug, on the days you take the study drug (just before or just after you get the study drug) or at the end of treatment. In addition, a blood sample will be collected at the end of cycle 2 and on day 8 of each cycle. Exceptions to this are:  
PK studies on days 1 and 5 of cycle 1 and on day 1of cycle 2. These samples will be drawn before your infusion and periodically for up to 6 hours after the start of infusion.  
Optional biopsies which may be collected before the first dose of LMB-100 (if you have not given a biopsy at screening) and after you have completed two cycles of therapy. The biopsies to be performed are exclusively for research purposes and will not benefit you. It might help other people in the future. You will be given the opportunity to decide whether you want to have these sample collected at the time of each biopsy. All tissue will be reviewed by the NCI Laboratory of Pathology.  
File in Section 4: Protocol Consent (1) Version Date: 03/01/2020  
Page 3 **of** 13  
CC ICF template v. 09.27.19

Once it is determined that you are eligible and you have signed the consent for the study, you will receive IV infusions of LMB-100 and nab-**paclitaxel. as described above. Each infusion will last** about 30 minutes, but it might take longer if your study doctor decides it is needed for your safety. Each nab-paclitaxel infusion also lasts about 30 minutes. On day 1 of each cycle, when both medications are given, you will receive the LMB-100 about 30 minutes after you have completed the nab-paclitaxel infusion. You will be monitored for side effects for 2 hours after the first infusion, and for 30 minutes after all other infusions if no side effects occurred previously. We will give you standard pre-medications that include an antihistamine (such a Benadryl), acetaminophen (Tylenol), ranitidine (Zantac) and dexamethasone, a steroid to help prevent infusion related side effects. While you are taking study medication, we will perform a number of tests and examinations for safety and to test the effect of the study therapy.  
These include routine blood and urine tests that will be done 4 - 5 times per cycle, a chest X-ray on day 1 of each cycle, scans that will be performed approximately every 6 weeks, and ECGs that will be done just before each infusion. We will also perform tests for research studies to find out how your body handles the drug (PKs), the types of immune cells present in your disease, how your body reacts to the drug and how certain side effects of the LMB-100 might be caused. Most of the sampling for these research tests will be done before your first dose of study drug, on the days you take the study drug (just before or just after you get the study drug) or at the end of treatment. In addition, a blood sample will be collected at the end of cycle 2 and on day 8 of the first two cycles. Exceptions to this are:
PK studies will be performed on days 1 and 5 of cycles 1 and 2. Except for the cycle 2 day  
 5 sample, which will only be drawn immediately before and after the LMB-100 infusion, these samples will be drawn before your infusion and periodically for up to 6 hours after the start of infusion.  
File in Section 4: Protocol Consent (2) Version Date: 03/01/2020  
Page 3 **of** 16  
CC ICF template v. 09.27.19  
Optional biopsies which may be collected before the first dose of LMB-100 (if you have not given a biopsy at screening) and after you have completed two cycles of therapy. The biopsies to be performed are exclusively for research purposes and will not benefit you. It might help other people in the future. You will be given the opportunity to decide whether you want to have these sample collected at the time of each biopsy. All tissue will be reviewed by the NCI Laboratory of Pathology.

Approximately 4 - 6 weeks after you have had your last dose of study drug, you will be asked to return to the NIH for a follow up visit to have the following tests:
Medical history and physical exam Routine blood and urine tests Scans if your disease has not worsened since the beginning of the study ECG
If after this visit, your disease remains stable or improves, you will continue to be scanned every 6 weeks until your disease worsens. About once a year, regardless of whether your disease has gotten worse, we will contact you or your physician by telephone to ask about any other cancer therapies you may have started and about your survival status.

Approximately 4 - 6 weeks after you have had your last dose of study drug, you will be asked to return to the NIH for a follow up visit to have the following tests:
Medical history and physical exam Routine blood and urine tests Scans if your disease has not worsened since the beginning of the study ECG
If after this visit, your disease remains stable or improves, you will continue to be scanned every 6 weeks until your disease worsens. About once a year, regardless of whether your disease has gotten worse, we will contact you or your physician by telephone to ask about any other cancer therapies you may have started and about your survival status.

Before beginning the study, you will need to undergo tests and/or procedures to help your doctor verify whether you can participate. This is called screening. Most of the exams, tests, and procedures you will have are part of the usual approach for your cancer. However, there are some extra procedures that you will need to have if you take part in this study. If you have already undergone some of these examinations very recently, your doctor may decide not to repeat them. Briefly, these tests, which are performed under a separate consent, include:
Confirmation of diagnosis (You must provide a sample tumor tissue for an evaluation from the NCI Laboratory of Pathology. The tissue may be from a previous surgery, biopsy or  
File in Section 4: Protocol Consent (1) Version Date: 03/01/2020  
Page 2 **of** 13  
CC ICF template v. 09.27.19  
collection from a tumor effusion (fluid around the tumor). If none is available, we will ask you to have a biopsy or a collection of effusion material to provide a fresh sample). Please see page 7, Tumor Biopsies and Effusions for a description of the procedure.  
Medical history and physical examination Routine blood and urine tests including pregnancy test in women who can have children. Pregnant women will not be allowed on study.  
Scans and x-rays Electrocardiogram (ECG) Echocardiogram Tests for viruses (hepatitis and HIV)

Before beginning the study, you will need to undergo tests and/or procedures to help your doctor verify whether you can participate. This is called screening. Most of the exams, tests, and procedures you will have are part of the usual approach for your cancer. However, there are some extra procedures that you will need to have if you take part in this study. If you have already undergone some of these examinations very recently, your doctor may decide not to repeat them. Briefly, these tests, which are performed under a separate consent, include:  
Confirmation of diagnosis (You must provide a sample tumor tissue for an evaluation by the NCI Laboratory of Pathology. The tissue may be from a previous surgery, biopsy or collection from a tumor effusion (fluid around the tumor). If none is available, we will ask you to have a biopsy or a collection of effusion material to provide a fresh sample). Please see page 10, Tumor Biopsies and Effusions for a description of the procedure.  
Medical history and physical examination Routine blood and urine tests including pregnancy test in women who can have children.  
Pregnant women will not be allowed on study.  
Scans and x-rays Electrocardiogram (ECG) Echocardiogram Tests for viruses (hepatitis and HIV)

Once it is determined that you are eligible and you have signed the consent for the study, you will receive IV infusions of LMB-100 as described above. Each infusion will last about 30 minutes, but it might take longer if your study doctor decides it is needed for your safety. You will be monitored for side effects for 2 hours after the first infusion, and for 30 minutes after all other infusions if no side effects occurred previously. We will give you standard pre-medications that include an antihistamine (such a Benadryl), acetaminophen (Tylenol), ranitidine (Zantac) and dexamethasone, a steroid to help prevent infusion related side effects. While you are taking study medication, we will perform a number of tests and examinations for safety and to test the effect of the study therapy. These include routine blood and urine tests that will be done 4 - 5 times per cycle, a chest X-ray on day 1 of each cycle, scans that will be performed approximately every 6 weeks, and ECGs that will be done just before each infusion. We will also perform tests for research studies to find out how your body handles the drug (PKs), the types of immune cells present in your disease, how your body reacts to the drug and how certain side effects of the LMB-100 might be caused. Most of the sampling for these research tests will be done before your first dose of study drug, on the days you take the study drug (just before or just after you get the study drug) or at the end of treatment. In addition, a blood sample will be collected at the end of cycle 2 and on day 8 of each cycle. Exceptions to this are:  
PK studies on days 1 and 5 of cycle 1 and on day 1of cycle 2. These samples will be drawn before your infusion and periodically for up to 6 hours after the start of infusion.  
Optional biopsies which may be collected before the first dose of LMB-100 (if you have not given a biopsy at screening) and after you have completed two cycles of therapy. The biopsies to be performed are exclusively for research purposes and will not benefit you. It might help other people in the future. You will be given the opportunity to decide whether you want to have these sample collected at the time of each biopsy. All tissue will be reviewed by the NCI Laboratory of Pathology.  
File in Section 4: Protocol Consent (1) Version Date: 03/01/2020  
Page 3 **of** 13  
CC ICF template v. 09.27.19

Once it is determined that you are eligible and you have signed the consent for the study, you will receive IV infusions of LMB-100 and nab-**paclitaxel. as described above. Each infusion will last** about 30 minutes, but it might take longer if your study doctor decides it is needed for your safety. Each nab-paclitaxel infusion also lasts about 30 minutes. On day 1 of each cycle, when both medications are given, you will receive the LMB-100 about 30 minutes after you have completed the nab-paclitaxel infusion. You will be monitored for side effects for 2 hours after the first infusion, and for 30 minutes after all other infusions if no side effects occurred previously. We will give you standard pre-medications that include an antihistamine (such a Benadryl), acetaminophen (Tylenol), ranitidine (Zantac) and dexamethasone, a steroid to help prevent infusion related side effects. While you are taking study medication, we will perform a number of tests and examinations for safety and to test the effect of the study therapy.  
These include routine blood and urine tests that will be done 4 - 5 times per cycle, a chest X-ray on day 1 of each cycle, scans that will be performed approximately every 6 weeks, and ECGs that will be done just before each infusion. We will also perform tests for research studies to find out how your body handles the drug (PKs), the types of immune cells present in your disease, how your body reacts to the drug and how certain side effects of the LMB-100 might be caused. Most of the sampling for these research tests will be done before your first dose of study drug, on the days you take the study drug (just before or just after you get the study drug) or at the end of treatment. In addition, a blood sample will be collected at the end of cycle 2 and on day 8 of the first two cycles. Exceptions to this are:
PK studies will be performed on days 1 and 5 of cycles 1 and 2. Except for the cycle 2 day  
 5 sample, which will only be drawn immediately before and after the LMB-100 infusion, these samples will be drawn before your infusion and periodically for up to 6 hours after the start of infusion.  
File in Section 4: Protocol Consent (2) Version Date: 03/01/2020  
Page 3 **of** 16  
CC ICF template v. 09.27.19  
Optional biopsies which may be collected before the first dose of LMB-100 (if you have not given a biopsy at screening) and after you have completed two cycles of therapy. The biopsies to be performed are exclusively for research purposes and will not benefit you. It might help other people in the future. You will be given the opportunity to decide whether you want to have these sample collected at the time of each biopsy. All tissue will be reviewed by the NCI Laboratory of Pathology.

Approximately 4 - 6 weeks after you have had your last dose of study drug, you will be asked to return to the NIH for a follow up visit to have the following tests:
Medical history and physical exam Routine blood and urine tests Scans if your disease has not worsened since the beginning of the study ECG
If after this visit, your disease remains stable or improves, you will continue to be scanned every 6 weeks until your disease worsens. About once a year, regardless of whether your disease has gotten worse, we will contact you or your physician by telephone to ask about any other cancer therapies you may have started and about your survival status.

Approximately 4 - 6 weeks after you have had your last dose of study drug, you will be asked to return to the NIH for a follow up visit to have the following tests:
Medical history and physical exam Routine blood and urine tests Scans if your disease has not worsened since the beginning of the study ECG
If after this visit, your disease remains stable or improves, you will continue to be scanned every 6 weeks until your disease worsens. About once a year, regardless of whether your disease has gotten worse, we will contact you or your physician by telephone to ask about any other cancer therapies you may have started and about your survival status.
Clinical trial: NCT02798536
Section: Purpose of Research
Subsections: Why Is This Study Being Done?|Why Is This Study Being Done?|Why Are You Being Asked To Take Part In This Study?|Why Are You Being Asked To Take Part In This Study?|Description Of Research Study|Description Of Research Study|Why Is This Study Being Done?|Why Is This Study Being Done?|Why Are You Being Asked To Take Part In This Study?|Why Are You Being Asked To Take Part In This Study?|Description Of Research Study|Description Of Research Study

In this study, we will determine a safe dose of LMB-100 in patients with advanced mesothelioma with or without nab-**paclitaxel. LMB-100 is an investigational agent, meaning that it has not been** approved by the US Food and Drug Administration. It is a type of manufactured protein which is similar to protein normally produced by your body in response to a specific foreign substance.  
LMB-100 is attracted to the mesothelin protein, which is present in a lot of different tumors, File in Section 4: Protocol Consent (1) Version Date: 03/01/2020 Page 1 **of** 13 CC ICF template v. 09.27.19 including mesothelioma, but is found in only a very small number of normal tissues. After binding to the mesothelin on tumors, LMB-100 can then attack and kill cancer cells. Nab-**paclitaxel is an** FDA approved agent used in the treatment of breast cancer, non-small cell lung cancer and pancreatic cancer. Its use in this study is investigational as it has not been approved in the treatment of mesothelioma. Part A of the study included two groups of patients (Arms A1 and A2) who were assigned to receive LMB-100 alone. In part B, two other groups (Arms B1 and B2) will be assigned to receive LMB-100 with nab**-paclitaxel. You are participating in either Arm A1** or A2 depending on when you were enrolled on the study..

In this study, we will determine a safe dose of LMB-100 in patients with advanced mesothelioma with or without nab-**paclitaxel. LMB-100 is an investigational agent, meaning that it has not been** approved by the US Food and Drug Administration. It is a type of manufactured protein which is similar to protein normally produced by your body in response to a specific foreign substance.  
LMB-100 is attracted to the mesothelin protein, which is present in a lot of different tumors, File in Section 4: Protocol Consent (2) Version Date: 03/01/2020 Page 1 **of** 16 CC ICF template v. 09.27.19 including mesothelioma, but is found in only a very small number of normal tissues. After binding to the mesothelin on tumors, LMB-100 can then attack and kill cancer cells. Nab-**paclitaxel is an** FDA approved agent used in the treatment of breast cancer, non-small cell lung cancer and pancreatic cancer. Its use in this study is investigational as it has not been approved in the treatment of mesothelioma. Part A of the study included two groups of patients (Arms A1 and A2) who were assigned to receive LMB-100 alone. In part B, two other groups (Arms B1 and B2) will be assigned to receive LMB-100 with nab**-paclitaxel. You will participate in either Arm B1** or B2 depending on when you enroll in the study.

You are being asked to take part in this study because you have pleural or peritoneal mesothelioma that has not responded to prior platinum based therapy.

You are being asked to take part in this study because you have pleural or peritoneal mesothelioma that has not responded to prior platinum based therapy.

The first 3 participants were enrolled in the phase 1 portion of part A (Arm A1) at the highest dose of LMB-100 that we will test. As there were intolerable side effects in more than 1 subject at this dose, the next lowest dose was given in the next 7 subjects enrolled and the 3 original subjects received the lower dose during their next treatment cycles. Of these 10 participants; 9 had stable disease, meaning the tumor did not change in size, while in 1 subject the tumors grew. There were no intolerable side effects at this dose. No additional patients will be enrolled in part A, but you will continue to receive LMB-100 alone if your disease has not worsened. Please note that based on the information from ongoing clinical trials of LMB-100, giving LMB-100 alone for more than 2 cycles provides no additional clinical benefit as we are unable to detect LMB-100 in the majority of participants beyond cycle 2. You will receive LMB-100 through an IV catheter (a tube inserted in a vein, usually in your arm) on day 1, day 3 and day 5 of each 21-day cycle. You will receive LMB-100 for up to 4 cycles or until your disease worsens or you have intolerable side effects, whichever happens first. We will continue to follow you after you have finished taking the study drug to keep track of your disease status (progression), your survival status or whether you have taken any additional cancer therapy. The specific procedures you will have are described below.

In Part A of the study a safe dose of LMB-100 alone has been established; however, 9 of 10 subjects who were evaluated had their tumors remain stable, while 1 subject's tumor grew.  
Therefore, we will enroll Part B to determine a safe dose of LMB-100 in combination with nab-**paclitaxel.**
The first 6 participants will be enrolled in the phase 1 portion of part B (Arm B1) at a slightly lower dose of LMB-100 than the safe dose of part A in combination with a nab-**paclitaxel. If it is** found to be safe, 10 additional participants will be enrolled (Arm B2) so that we may begin to determine whether the study therapy can shrink tumors. If there are too many intolerable side effects, we will test a lower dose of LMB-100 in combination with nab**-paclitaxel in the next 6** participants and the enroll an additional 10 patients at that dose level. You will receive LMB-100 through an IV catheter (a tube inserted in a vein, usually in your arm) on day 1, day 3 and day 5 of each 21-day cycle. You will receive LMB-100 for up to 2 cycles or until your disease worsens or you have intolerable side effects, whichever happens first. You will receive nab-**paclitaxel through an IV on day 1 and day 8 of each 21-day cycle for up to 6 cycles or** until your disease worsens or you have intolerable side effects caused, whichever happens first. We will continue to follow you after you have finished taking the study drug to keep track of your disease status (progression), your survival status or whether you have taken any additional cancer therapy. The specific procedures you will have are described below.

In this study, we will determine a safe dose of LMB-100 in patients with advanced mesothelioma with or without nab-**paclitaxel. LMB-100 is an investigational agent, meaning that it has not been** approved by the US Food and Drug Administration. It is a type of manufactured protein which is similar to protein normally produced by your body in response to a specific foreign substance.  
LMB-100 is attracted to the mesothelin protein, which is present in a lot of different tumors, File in Section 4: Protocol Consent (1) Version Date: 03/01/2020 Page 1 **of** 13 CC ICF template v. 09.27.19 including mesothelioma, but is found in only a very small number of normal tissues. After binding to the mesothelin on tumors, LMB-100 can then attack and kill cancer cells. Nab-**paclitaxel is an** FDA approved agent used in the treatment of breast cancer, non-small cell lung cancer and pancreatic cancer. Its use in this study is investigational as it has not been approved in the treatment of mesothelioma. Part A of the study included two groups of patients (Arms A1 and A2) who were assigned to receive LMB-100 alone. In part B, two other groups (Arms B1 and B2) will be assigned to receive LMB-100 with nab**-paclitaxel. You are participating in either Arm A1** or A2 depending on when you were enrolled on the study..

In this study, we will determine a safe dose of LMB-100 in patients with advanced mesothelioma with or without nab-**paclitaxel. LMB-100 is an investigational agent, meaning that it has not been** approved by the US Food and Drug Administration. It is a type of manufactured protein which is similar to protein normally produced by your body in response to a specific foreign substance.  
LMB-100 is attracted to the mesothelin protein, which is present in a lot of different tumors, File in Section 4: Protocol Consent (2) Version Date: 03/01/2020 Page 1 **of** 16 CC ICF template v. 09.27.19 including mesothelioma, but is found in only a very small number of normal tissues. After binding to the mesothelin on tumors, LMB-100 can then attack and kill cancer cells. Nab-**paclitaxel is an** FDA approved agent used in the treatment of breast cancer, non-small cell lung cancer and pancreatic cancer. Its use in this study is investigational as it has not been approved in the treatment of mesothelioma. Part A of the study included two groups of patients (Arms A1 and A2) who were assigned to receive LMB-100 alone. In part B, two other groups (Arms B1 and B2) will be assigned to receive LMB-100 with nab**-paclitaxel. You will participate in either Arm B1** or B2 depending on when you enroll in the study.

You are being asked to take part in this study because you have pleural or peritoneal mesothelioma that has not responded to prior platinum based therapy.

You are being asked to take part in this study because you have pleural or peritoneal mesothelioma that has not responded to prior platinum based therapy.

The first 3 participants were enrolled in the phase 1 portion of part A (Arm A1) at the highest dose of LMB-100 that we will test. As there were intolerable side effects in more than 1 subject at this dose, the next lowest dose was given in the next 7 subjects enrolled and the 3 original subjects received the lower dose during their next treatment cycles. Of these 10 participants; 9 had stable disease, meaning the tumor did not change in size, while in 1 subject the tumors grew. There were no intolerable side effects at this dose. No additional patients will be enrolled in part A, but you will continue to receive LMB-100 alone if your disease has not worsened. Please note that based on the information from ongoing clinical trials of LMB-100, giving LMB-100 alone for more than 2 cycles provides no additional clinical benefit as we are unable to detect LMB-100 in the majority of participants beyond cycle 2. You will receive LMB-100 through an IV catheter (a tube inserted in a vein, usually in your arm) on day 1, day 3 and day 5 of each 21-day cycle. You will receive LMB-100 for up to 4 cycles or until your disease worsens or you have intolerable side effects, whichever happens first. We will continue to follow you after you have finished taking the study drug to keep track of your disease status (progression), your survival status or whether you have taken any additional cancer therapy. The specific procedures you will have are described below.

In Part A of the study a safe dose of LMB-100 alone has been established; however, 9 of 10 subjects who were evaluated had their tumors remain stable, while 1 subject's tumor grew.  
Therefore, we will enroll Part B to determine a safe dose of LMB-100 in combination with nab-**paclitaxel.**
The first 6 participants will be enrolled in the phase 1 portion of part B (Arm B1) at a slightly lower dose of LMB-100 than the safe dose of part A in combination with a nab-**paclitaxel. If it is** found to be safe, 10 additional participants will be enrolled (Arm B2) so that we may begin to determine whether the study therapy can shrink tumors. If there are too many intolerable side effects, we will test a lower dose of LMB-100 in combination with nab**-paclitaxel in the next 6** participants and the enroll an additional 10 patients at that dose level. You will receive LMB-100 through an IV catheter (a tube inserted in a vein, usually in your arm) on day 1, day 3 and day 5 of each 21-day cycle. You will receive LMB-100 for up to 2 cycles or until your disease worsens or you have intolerable side effects, whichever happens first. You will receive nab-**paclitaxel through an IV on day 1 and day 8 of each 21-day cycle for up to 6 cycles or** until your disease worsens or you have intolerable side effects caused, whichever happens first. We will continue to follow you after you have finished taking the study drug to keep track of your disease status (progression), your survival status or whether you have taken any additional cancer therapy. The specific procedures you will have are described below.
Clinical trial: NCT02798536
Section: Voluntary Participation
Subsections: It Is Your Choice To Take Part In The Study|It Is Your Choice To Take Part In The Study|It Is Your Choice To Take Part In The Study|It Is Your Choice To Take Part In The Study

You may choose not to take part in this study for any reason. If you join this study, you may change your mind and stop participating in the study at any time and for any reason. In either case, you will not lose any benefits to which you are otherwise entitled. However, to be seen at the NIH, you must be taking part in a study or are being considered for a study. If you do choose to leave the study, please inform your study team to ensure a safe withdrawal from the research.

You may choose not to take part in this study for any reason. If you join this study, you may change your mind and stop participating in the study at any time and for any reason. In either case, you will not lose any benefits to which you are otherwise entitled. However, to be seen at the NIH, you must be taking part in a study or are being considered for a study. If you do choose to leave the study, please inform your study team to ensure a safe withdrawal from the research.

You may choose not to take part in this study for any reason. If you join this study, you may change your mind and stop participating in the study at any time and for any reason. In either case, you will not lose any benefits to which you are otherwise entitled. However, to be seen at the NIH, you must be taking part in a study or are being considered for a study. If you do choose to leave the study, please inform your study team to ensure a safe withdrawal from the research.

You may choose not to take part in this study for any reason. If you join this study, you may change your mind and stop participating in the study at any time and for any reason. In either case, you will not lose any benefits to which you are otherwise entitled. However, to be seen at the NIH, you must be taking part in a study or are being considered for a study. If you do choose to leave the study, please inform your study team to ensure a safe withdrawal from the research.
Clinical trial: NCT02798536
Section: Withdrawal from Study
Subsections: Stopping Therapy|Stopping Therapy|Stopping Therapy|Stopping Therapy

Your doctor may decide to stop your therapy for the following reasons:  
if he/she believes that it is in your best interest if your disease comes back during treatment if you become pregnant if you have side effects from the treatment that your doctor thinks are too severe if new information shows that another treatment would be better for you
In this case, you will be informed of the reason therapy is being stopped. You can stop taking part in the study at any time. However, if you decide to stop taking part in the study, we would like you to talk to the study doctor and your regular doctor first. If you decide at any time to withdraw your consent to participate in the trial, we will not collect any additional medical information about you. However, according to FDA guidelines, information collected on you up to that point may still be provided to collaborators or designated representatives. If you withdraw your consent and leave the trial, any samples of yours that have been obtained for the study and stored at the NCI can be destroyed upon request. However, any samples and data generated from the samples that have already been distributed to other researchers or placed in the research databases cannot **be recalled and destroyed.**

Your doctor may decide to stop your therapy for the following reasons:  
if he/she believes that it is in your best interest if your disease comes back during treatment if you become pregnant if you have side effects from the treatment that your doctor thinks are too severe if new information shows that another treatment would be better for you
In this case, you will be informed of the reason therapy is being stopped. You can stop taking part in the study at any time. However, if you decide to stop taking part in the study, we would like you to talk to the study doctor and your regular doctor first. If you decide at any time to withdraw your consent to participate in the trial, we will not collect any additional medical information about you. However, according to FDA guidelines, information collected on you up to that point may still be provided to collaborators or designated representatives. If you withdraw your consent and leave the trial, any samples of yours that have been obtained for the study and stored at the NCI can be destroyed upon request. However, any samples and data generated from the samples that have already been distributed to other researchers or placed in the research databases cannot **be recalled and destroyed.**

Your doctor may decide to stop your therapy for the following reasons:  
if he/she believes that it is in your best interest if your disease comes back during treatment if you become pregnant if you have side effects from the treatment that your doctor thinks are too severe if new information shows that another treatment would be better for you
In this case, you will be informed of the reason therapy is being stopped. You can stop taking part in the study at any time. However, if you decide to stop taking part in the study, we would like you to talk to the study doctor and your regular doctor first. If you decide at any time to withdraw your consent to participate in the trial, we will not collect any additional medical information about you. However, according to FDA guidelines, information collected on you up to that point may still be provided to collaborators or designated representatives. If you withdraw your consent and leave the trial, any samples of yours that have been obtained for the study and stored at the NCI can be destroyed upon request. However, any samples and data generated from the samples that have already been distributed to other researchers or placed in the research databases cannot **be recalled and destroyed.**

Your doctor may decide to stop your therapy for the following reasons:  
if he/she believes that it is in your best interest if your disease comes back during treatment if you become pregnant if you have side effects from the treatment that your doctor thinks are too severe if new information shows that another treatment would be better for you
In this case, you will be informed of the reason therapy is being stopped. You can stop taking part in the study at any time. However, if you decide to stop taking part in the study, we would like you to talk to the study doctor and your regular doctor first. If you decide at any time to withdraw your consent to participate in the trial, we will not collect any additional medical information about you. However, according to FDA guidelines, information collected on you up to that point may still be provided to collaborators or designated representatives. If you withdraw your consent and leave the trial, any samples of yours that have been obtained for the study and stored at the NCI can be destroyed upon request. However, any samples and data generated from the samples that have already been distributed to other researchers or placed in the research databases cannot **be recalled and destroyed.**