Clinical trial NCT06154291: FIH XON7 in Advanced/Metastatic Solid Tumors
Official title: Phase I/II, Multi Center, Open Label, First-in-human, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, and Anti-tumors Efficacy of the Glyco-humanized Polyclonal Antibody XON7 in Patients With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumor
Metastatic Cancer
Keywords: Advanced or metastatic solid tumors
Lead sponsor: Xenothera SAS
Sponsor class: INDUSTRY
First posted: 2023-12-04
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The Part I component is a multicenter, open-label, multiple-dose, dose escalation, first-in-human study. Six dose levels are planned: 1.5; 3; 6; 12; 16 and 20mg/kg, Q2W (once every two weeks). Up to 45 participants with relapsed or refractory, advanced or metastatic solid tumors will be included.

The Part II component is a multi-center, open-label, non-randomized, multi-cohorts, expansion trial with adaptive design.

The selected cohorts of the study will investigate RP2D to determine the anti-tumors efficacy, safety, and tolerability of XON7 in participants with relapsed or refractory, advanced or metastatic solid tumors after failure to standard of care treatments.

Up to 7 cohorts could be investigated. A maximum of 30 participants will be enrolled in each cohort.
Primary purpose: TREATMENT

Brief summary: This is a two-stage trial consisting of a Part I, dose escalation and dose-finding component to establish the Maximal Tolerated Dose (MTD), if any, and Recommended Part 2 Dose (RP2D) of XON7, followed by a Part II component to investigate anti-tumors efficacy in selected solid tumor types and to further evaluate safety and tolerability of XON7 at RP2D.


Eligibility criteria: Inclusion Criteria:

1. Provide signed, written informed consent.
2. Male and female participant, age ≥ 18 years old (at the time consent is obtained)
3. Solid tumors indications:

   * Participant in phase I, must have a histologically or cytologically confirmed advanced or metastatic solid tumors for which no effective standard therapy is available. All tumor types except glioblastoma, could be included.
   * Participant in phase II, must have histologically or cytologically confirmed advanced or metastatic solid tumors of the following: NSCLC, gastro-esophageal adenocarcinoma, CRC, pancreatic cancer, Sarcoma, TNBC, or ovarian cancer.
4. Line of treatment: Participant must have solid tumors progressing after ≤ 4 lines of standard appropriate anticancer therapies for the specific tumor type, or for which the patient is ineligible. Participants whose cancers harbor molecular alterations for which targeted therapy is standard of care should have received health authority-approved appropriate targeted therapy for their tumor types before enrollment.
5. Measurable disease per RECIST version 1.1 - v5
6. (ECOG) performance status (PS) 0-1
7. Life expectancy of at least 12 weeks.
8. Adequate organ function
9. QT duration corrected for heart rate by Fridericia's formula (QTcF) \<450 msec or QTcF \<480 msec for participants with bundle branch block.
10. In France, a participant will be eligible for inclusion in this trial only if either affiliated to or a beneficiary of a social security category.
11. Female participant who are not of child-bearing potential, and female participants of child-bearing potential who have a negative serum pregnancy test within 7 days prior to initial trial treatment. Female participants of child-bearing potential, and all male partners must consent to use a medically acceptable method of contraception throughout the trial period and for at least 60 days after the last dose of XON7. A barrier method of contraception must be included.
12. Male participant willing to use adequate contraceptive measures throughout the trial period and for at least 60 days after the last dose of trial intervention.
13. For phase II, participant in pharmacodynamics cohort must provide biopsy of a tumor lesion not previously irradiated during the screening period and must agree to provide at least one additional on-treatment biopsy between day 36 and 42 after trial intervention administration.
14. For phase II, participant in pharmacodynamics cohort must have accessible tumor tissue available for fresh biopsy except for ovarian cancer and sarcoma.

Exclusion Criteria:

1. A participant who has received more than 4 prior lines of therapy for advanced or metastatic disease.
2. A participant who has had a prior anti-cancer mAb within 3 weeks prior to trial Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier prior to trial Day 1.
3. A participant who has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to trial Day 1 or who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent (Except alopecia, hearing loss, grade 2 neuropathy or endocrinopathy managed with replacement therapy).
4. A participant with ≥Grade 3 toxicity related to prior immunotherapy leading to treatment discontinuation.
5. A participant whose toxicity related to prior treatment has not resolved to Grade 1 (except alopecia, hearing loss, grade 2 neuropathy or endocrinopathy managed with replacement therapy).
6. A participant who has received major surgery 2 weeks before the first dose of trial treatment or has not recovered adequately from the toxicity and/or complications from any surgery (major or minor) before initiating trial treatment.
7. Concomitant use of another experimental drug, or wash-out period of at least 5 half-lives for a previous experimental drug not completed before start of trial intervention
8. Participant treated with drugs known to prolong the QT interval
9. Participant with carcinomatous meningitis.
10. Central nervous system (CNS) metastases, with the exception of individuals who have been previously treated CNS metastases, are asymptomatic, and have had no requirement for steroids for 3 weeks prior to first dose of trial drug.
11. Malignancies other than disease under trial within 3 years prior to first dose of trial intervention.
12. History of autoimmune disease
13. Active or uncontrolled infections requiring systemic treatment (known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen or hepatitis C).
14. Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the trial such as history or evidence of cardiovascular risk including any of the following:

    * Recent (within the past 6 months) history of serious uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities including second degree (Type II) or third-degree atrioventricular block.
    * Documented cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting, or bypass grafting within the past 6 months before enrollment.
    * Documented congestive heart failure (Class II, III, or IV) as defined by the New York Heart Association functional classification system (NYHA, 1994).
15. Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.
16. Current active liver or biliary disease (Except for Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per investigator assessment).
17. Concurrent medical condition requiring the use of systemic immunosuppressive medications within 28 days before the first dose of trial treatment.
18. Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction.
19. Current or history of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia. Note: post-radiation changes in the lung related to prior radiotherapy and/or asymptomatic radiation-induced pneumonitis not requiring treatment may be permitted if agreed by the investigator and Medical Monitor.
20. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
21. Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions.
22. Participant who has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony- stimulating factor \[G-CSF\], granulocyte-macrophage colony-stimulating factor \[GM- CSF\], recombinant erythropoietin) within 2 weeks before the first dose of trial intervention.
23. Known, current drug or alcohol abuse.
24. Female participant who is pregnant or lactating.
25. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
26. Inability or unwillingness to comply with trial and/or follow-up procedures outlined in the protocol.
27. For France, patients under legal protection (safeguard, guardianship, curatorship)

Primary outcomes:
measure: Dose Escalation part: Dose Limiting Toxicities (DLTs)
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: treatment emergent adverse events (TEAEs)
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Leucocytes count
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Red Blood Cells Count
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Hemoglobin
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Hematocrit
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Absolute Neutrophil Count
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Absolute Eosinophil Count
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Absolute Basophil Count
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Absolute Lymphocytes Count
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Absolute Monocytes Count
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Platelet Count
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Albumin
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Bicarbonate
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Total Bilirubin
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Calcium
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Urea
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Chloride
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Creatinine
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Creatinine Clearance
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Glucose
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Magnesium
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Phosphate
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Potassium
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Sodium
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Total Protein
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Alanine aminotransferase (ALT)
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Aspartate aminotransferase (AST)
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Gamma-glutamyl transférase (GGT)
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Alkaline Phosphatase (ALP)
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Lactate dehydrogenase (LDH)
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Amylase
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Lipase
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Total Protein Creatine Kinase (CK)
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Creatine kinase - cardiac muscle isoenzyme (CK-MB)
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Troponin T
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Prothrombin Time (PT)
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in INR (if under VKA Therapy)
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant changes in Activated Partial Thromboplastin Time (aPTT)
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant findings in blood pressure (BP)
timeFrame: At the end of Cycle 1 (28 days)
measure: Dose Escalation part: clinically significant findings in electrocardiogram (ECGs)
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: Anti-tumors efficacy
timeFrame: Within 3 months after XON7 initiation
Secondary outcomes:
measure: Pharmacokinetics (PK) of XON7 (Part 1): Cmax
timeFrame: Cycle 1-Day 1 Predose and Postdose: 5 minutes; 1; 2; 4; 8; 24; 72 or 96; 144 hours after the end of infusion. Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 7 Day 1: Predose and 5 minutes after the end of infusion
measure: Pharmacokinetics (PK) of XON7 (Part 2): Cmax
timeFrame: Cycle 1-Day 1; Cycle 2-Day 1; Cycle 3-Day 1; Cycle 6-Day 1; Cycle 9-Day1 and Cycle 12-Day 1: Predose and 5 minutes after the end of infusion
measure: Pharmacokinetics (PK) of XON7 (Part 1): Tmax
timeFrame: Cycle 1-Day 1 Predose and Postdose: 5 minutes; 1; 2; 4; 8; 24; 72 or 96; 144 hours after the end of infusion. Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 7 Day 1: Predose and 5 minutes after the end of infusion
measure: Pharmacokinetics (PK) of XON7 (Part 2): Tmax
timeFrame: Cycle 1-Day 1; Cycle 2-Day 1; Cycle 3-Day 1; Cycle 6-Day 1; Cycle 9-Day1 and Cycle 12-Day 1: Predose and 5 minutes after the end of infusion
measure: Pharmacokinetics (PK) of XON7 (Part 1): AUC
timeFrame: Cycle 1-Day 1 Predose and Postdose: 5 minutes; 1; 2; 4; 8; 24; 72 or 96; 144 hours after the end of infusion. Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 7 Day 1: Predose and 5 minutes after the end of infusion
measure: Pharmacokinetics (PK) of XON7 (Part 2): AUC
timeFrame: Cycle 1-Day 1; Cycle 2-Day 1; Cycle 3-Day 1; Cycle 6-Day 1; Cycle 9-Day1 and Cycle 12-Day 1: Predose and 5 minutes after the end of infusion
measure: Pharmacokinetics (PK) of XON7 (Part 1): Ctrough
timeFrame: Cycle 1-Day 1 Predose and Postdose: 5 minutes; 1; 2; 4; 8; 24; 72 or 96; 144 hours after the end of infusion. Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 7 Day 1: Predose and 5 minutes after the end of infusion
measure: Pharmacokinetics (PK) of XON7 (Part 2): Ctrough
timeFrame: Cycle 1-Day 1; Cycle 2-Day 1; Cycle 3-Day 1; Cycle 6-Day 1; Cycle 9-Day1 and Cycle 12-Day 1: Predose and 5 minutes after the end of infusion
measure: Pharmacokinetics (PK) of XON7 (Part 1): Cmin
timeFrame: Cycle 1-Day 1 Predose and Postdose: 5 minutes; 1; 2; 4; 8; 24; 72 or 96; 144 hours after the end of infusion. Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 7 Day 1: Predose and 5 minutes after the end of infusion
measure: Pharmacokinetics (PK) of XON7 (Part 2): Cmin
timeFrame: Cycle 1-Day 1; Cycle 2-Day 1; Cycle 3-Day 1; Cycle 6-Day 1; Cycle 9-Day1 and Cycle 12-Day 1: Predose and 5 minutes after the end of infusion
measure: Pharmacokinetics (PK) of XON7 (Part 1): T1/2
timeFrame: Cycle 1-Day 1 Predose and Postdose: 5 minutes; 1; 2; 4; 8; 24; 72 or 96; 144 hours after the end of infusion. Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 7 Day 1: Predose and 5 minutes after the end of infusion
measure: Pharmacokinetics (PK) of XON7 (Part 2): T1/2
timeFrame: Cycle 1-Day 1; Cycle 2-Day 1; Cycle 3-Day 1; Cycle 6-Day 1; Cycle 9-Day1 and Cycle 12-Day 1: Predose and 5 minutes after the end of infusion
measure: Pharmacokinetics (PK) of XON7 (Part 1): CL
timeFrame: Cycle 1-Day 1 Predose and Postdose: 5 minutes; 1; 2; 4; 8; 24; 72 or 96; 144 hours after the end of infusion. Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 7 Day 1: Predose and 5 minutes after the end of infusion
measure: Pharmacokinetics (PK) of XON7 (Part 2): CL
timeFrame: Cycle 1-Day 1; Cycle 2-Day 1; Cycle 3-Day 1; Cycle 6-Day 1; Cycle 9-Day1 and Cycle 12-Day 1: Predose and 5 minutes after the end of infusion
measure: Pharmacokinetics (PK) of XON7 (Part 1): Vd
timeFrame: Cycle 1-Day 1 Predose and Postdose: 5 minutes; 1; 2; 4; 8; 24; 72 or 96; 144 hours after the end of infusion. Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 7 Day 1: Predose and 5 minutes after the end of infusion
measure: Pharmacokinetics (PK) of XON7 (Part 2): Vd
timeFrame: Cycle 1-Day 1; Cycle 2-Day 1; Cycle 3-Day 1; Cycle 6-Day 1; Cycle 9-Day1 and Cycle 12-Day 1: Predose and 5 minutes after the end of infusion
measure: Host immunogenicity to XON7 (Part 1 and part 2)
timeFrame: Cycle 1-Day 1; Cycle 1-Day4; Cycle 1-Day7; Cycle 1-Day15; Cycle 2 and additional cycles-Day1; 30 and 60 days after the last dose of XON7
measure: Host immunogenicity to XON7 (Part 1 and part 2)
timeFrame: Cycle 1-Day 1; Cycle 1-Day4; Cycle 1-Day7; Cycle 1-Day15; Cycle 2 and additional cycles-Day1; 30 and 60 days after the last dose of XON7
measure: Further assess anti-tumor efficacy (Part 1): ORR
timeFrame: Tumor imaging (computed tomography [CT]) will be performed within 28 days prior to enrollment, and while on study approximately every 8 weeks during the treatment period. During the survival follow-up, results of CT only performed in current practice
measure: Further assess anti-tumor efficacy (Part 2): CBR
timeFrame: Tumor imaging (computed tomography [CT]) will be performed within 28 days prior to enrollment, and while on study approximately every 8 weeks during the treatment period. During the survival follow-up, results of CT only performed in current practice
measure: Further assess anti-tumor efficacy (Part 1 and part 2): DCR
timeFrame: Tumor imaging (computed tomography [CT]) will be performed within 28 days prior to enrollment, and while on study approximately every 8 weeks during the treatment period. During the survival follow-up, results of CT only performed in current practice
measure: Further assess anti-tumor efficacy (Part 1 and part 2): DoR
timeFrame: Tumor imaging (computed tomography [CT]) will be performed within 28 days prior to enrollment, and while on study approximately every 8 weeks during the treatment period. During the survival follow-up, results of CT only performed in current practice
measure: Further assess anti-tumor efficacy (Part 2): TTR
timeFrame: Tumor imaging (computed tomography [CT]) will be performed within 28 days prior to enrollment, and while on study approximately every 8 weeks during the treatment period. During the survival follow-up, results of CT only performed in current practice
measure: Further assess anti-tumor efficacy (Part 1 and part 2): PFS
timeFrame: Tumor imaging (computed tomography [CT]) will be performed within 28 days prior to enrollment, and while on study approximately every 8 weeks during the treatment period. During the survival follow-up, results of CT only performed in current practice
measure: Further assess anti-tumor efficacy (Part 1 and part 2): OS
timeFrame: Tumor imaging (computed tomography [CT]) will be performed within 28 days prior to enrollment, and while on study approximately every 8 weeks during the treatment period. During the survival follow-up, results of CT only performed in current practice
measure: Expansion part: treatment emergent adverse events (TEAEs)
timeFrame: Participants will be assessed for AEs and SAEs beginning immediately after the first dose of investigational drug and continuing through to follow-up which is 60 ± 5 days of last dose of investigational drug.
measure: Dose Escalation part: clinically significant findings in blood pressure (BP)
timeFrame: Before and immediately after the first dose of investigational drug and continuing through to follow-up which is 60 ± 5 days of last dose of investigational drug
measure: Dose Escalation part: clinically significant findings in electrocardiogram (ECGs)
timeFrame: Before and immediately after the first dose of investigational drug and continuing through to follow-up which is 60 ± 5 days of last dose of investigational drug
measure: Expansion part: clinically significant changes in Leucocytes count
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Red Blood Cells Count
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Hemoglobin
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Hematocrit
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Absolute Neutrophil Count
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Absolute Eosinophil Count
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Absolute Basophil Count
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Absolute Lymphocytes Count
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Absolute Monocytes Count
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Platelet Count
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Albumin
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Bicarbonate
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Total Bilirubin
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Calcium
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Urea
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Chloride
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Creatinine
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Creatinine Clearance
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Glucose
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Magnesium
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Phosphate
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Potassium
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Sodium
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Total Protein
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Alanine aminotransferase (ALT)
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Aspartate aminotransferase (AST)
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Gamma-glutamyl transférase (GGT)
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Alkaline Phosphatase (ALP)
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Lactate dehydrogenase (LDH)
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Amylase
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Lipase
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Total Protein Creatine Kinase (CK)
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Creatine kinase - cardiac muscle isoenzyme (CK-MB)
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Troponin T
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Prothrombin Time (PT)
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in INR (if under VKA Therapy)
timeFrame: At the end of Cycle 1 (28 days)
measure: Expansion part: clinically significant changes in Activated Partial Thromboplastin Time (aPTT)
timeFrame: At the end of Cycle 1 (28 days)
Other outcomes:
Locations:
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Lyon
country: France
facility: Centre Léon Bérard
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulouse
country: France
facility: IUCT-Oncopole
Study officials:
affiliation: Hôpital Foch
name: Jaafar BENNOUNA, MD
role: PRINCIPAL_INVESTIGATOR
References: