Clinical trial NCT04152499: Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01)
Official title: A Phase I-II, First-in-Human Study of SKB264 in Patients With Locally Advanced Unresectable /Metastatic Solid Tumors Who Are Refractory to Available Standard Therapies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Epithelial Ovarian Cancer
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Urothelial Carcinoma
Non-Small Cell Lung Cancer
Small-Cell Lung Cancer
Endometrial Carcinoma
Head and Neck Squamous Cell Carcinoma
Breast Cancer
Cervical Cancer
Keywords: TROP2, ADC
Lead sponsor: Klus Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-05
Enrollment: 1410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A Phase I-II, First-in-Human Study of SKB264 (Sac-TMT; MK-2870) in Patients with Locally Advanced Unresectable/Metastatic Solid Tumors who are refractory to Available Standard Therapies. Patient must have historically documented, incurable, locally advanced or metastatic cancer that are refractory to standard therapies of one of the following types:

1. Triple negative breast cancer
2. Epithelial ovarian cancer
3. Non-small cell lung cancer
4. Gastric adenocarcinoma/Gastroesophageal junction adenocarcinoma
5. Small cell lung cancer
6. HR+/ HER2-breast cancer
7. Head and neck squamous cell carcinoma
8. Endometrial carcinoma
9. Urothelial carcinoma
10. Cervical cancer

Detailed description: This is an open label, Phase I-II, first in human (FIH) study for SKB264 as monotherapy in patients who have locally advanced unresectable or metastatic solid tumor that is refractory to all standard therapies. TROP2 (trophoblast antigen 2) assessments will not be performed prior to enrollment but it will be assessed retrospectively. Confirmation of TROP2 (trophoblast antigen 2) expression by immunohistology or other means is not required, but the Sponsor will request fresh tumor biopsy or tissue specimens from archived materials for determination of TROP2 (trophoblast antigen 2) expression retrospectively. The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy whose tumor is refractory to standard therapies. Patients will receive study drug as a single IV infusion at the prescribed dose level at each administration. Cycles will continue until disease progression or unacceptable toxicity. The study is divided into 2 parts (Phase I and Phase II).

Eligibility criteria: Diagnosis and Main Criteria for Inclusion:

Inclusion Criteria:

Patients must meet the following criteria for inclusion into the study:

Phase I:

1. Patients must be able to provide documented voluntary informed consent.
2. Male or female patient aged 18-75 years.
3. Histologically documented, incurable, locally advanced or metastatic epithelial origin malignant cancer, priority to include but not limited to the following tumor types:

   Breast cancer Ovarian epithelial cancer Non-small cell lung cancer Gastric adenocarcinoma Small cell lung cancer Urothelial carcinoma Note: Confirmation of TROP2 expression by immunohistology or other means is not required, but the Sponsor will request tissue specimens from fresh or archived materials for determination of TROP2 expression.
4. Measurable disease by CT/MRI during dose escalation.
5. Patients should have an unresectable locally advanced or metastatic solid tumor that is refractory to standard therapies, or have no standard therapies, or standard treatment is not applicable at this stage.
6. Granulocyte count ≥ 1.5×109/L, platelet count ≥ 100×109/L, and hemoglobin ≥ 9 g/dL.
7. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5×ULN.
8. Serum bilirubin ≤ 1.5 mg/dL (Patients with known Gilbert disease who have serum bilirubin level ≤ 3 ×ULN may be enrolled)., aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5 × upper limit of normal (ULN), with the exception of patients with hepatic metastases (ALT and AST ≤ 5 × ULN) and patients with hepatic and/or bone metastases (alkaline phosphatase ≤ 5 × ULN).
9. Creatinine clearance ≥ 50 mL/min calculated by Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration, or Modification of Diet in Renal Disease formulas. Note that 24 hour urine collection is not required but is allowed.
10. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
11. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception during study treatment. Female and male patient treated with SKB264 should continue contraception use for 7 months after the last dose. Such methods include combined (estrogen and progestogen containing) hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation together with another additional barrier method always containing a spermicide, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion or vasectomized partner (on the understanding that this is the only one partner during the whole study duration), and sexual abstinence.

    * Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drug. The same rules are valid for male patients involved in this clinical trial if they have a partner of childbirth potential. Male patients must always use a condom.
    * Women are excluded from birth control if they had had tubal ligation or a hysterectomy.
12. Patients must have recovered (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia and vitiligo.
13. Expected survival ≥ 3 months.

Phase II:

1. Patients must be able to provide documented voluntary informed consent.
2. Male or female patient aged ≥ 18 years.
3. Histologically or cytologically documented, incurable, locally advanced, recurrent or metastatic cancer, including the following tumor types:

   * Cohort 1: triple negative breast cancer (\< 1% expression for estrogen receptor \[ER\] and progesterone receptor \[PR\] and HER2 negative)
   * Cohort 2: ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
   * Cohort 3: non-small cell lung cancer
   * Cohort 4: gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (HER2 negative)
   * Cohort 6: HR+/ HER2- breast cancer (≥1% expression for ER and/or PR and HER2 negative)
   * Cohort 7: Head and neck squamous cell carcinoma (including primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx. Other primary tumor sites of HNSCC are not eligible)
   * Cohort 8: Endometrial carcinoma (including carcinosarcoma, but excluding sarcoma and neuroendocrine endometrial carcinoma)
   * Cohort 9: Urothelial carcinoma (including urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra, patients with mixed histology are eligible provided urothelial component \> 50% and plasmacytoid component\<10%, patients whose tumors contain any neuroendocrine component are not eligible)
   * Cohort 10: Cervical cancer (including squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix) Note: Evaluation of TROP-2 expression is required.
4. Measurable disease by CT/MRI.
5. Patients should have an unresectable locally advanced or metastatic solid tumor that is refractory to standard therapies.
6. Neutrophil count ≥ 1.5×109/L, platelet count ≥ 100×109/L, and hemoglobin ≥ 9 g/dL.
7. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5×ULN.
8. Serum bilirubin ≤ 1.5 ×ULN (Patients with known Gilbert disease who have serum bilirubin level ≤ 3 ×ULN may be enrolled), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5 × upper limit of normal (ULN), with the exception of patients with hepatic metastases (ALT and AST ≤ 5 × ULN) and patients with hepatic and/or bone metastases (alkaline phosphatase ≤ 5 × ULN).
9. Creatinine clearance ≥ 30 mL/min calculated by Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), or Modification of Diet in Renal Disease (MDRD) formulas. Note that 24 hour urine collection is not required but is allowed.
10. ECOG Performance Status 0 or 1.
11. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception during study treatment. Female and male patient treated with SKB264 should continue contraception use for 6 months after the last dose. Such methods include combined (estrogen and progestogen containing) hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation together with another additional barrier method always containing a spermicide, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion or vasectomized partner (on the understanding that this is the only one partner during the whole study duration), and sexual abstinence.

    * Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drug. The same rules are valid for male patients involved in this clinical trial if they have a partner of childbirth potential. Male patients must always use a condom.
    * Women are excluded from birth control if they had had tubal ligation or a hysterectomy.
12. Patients must have recovered (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia and vitiligo. Note: Subjects with endocrine AE of any grade are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.
13. Expected survival ≥ 3 months.

Exclusion Criteria:

Patients that meet the following criteria will be excluded from entry into the study:

Phase I:

1. Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure (New York Heart Association) III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 6 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia).
2. Symptomatic brain metastases or any radiation or surgery for brain metastases within 1 months of first infusion of study drug.
3. Subjects with second primary cancers (except for cured in situ non-melanoma skin cancer and in situ cervical cancer with no relapse in the last 3 years).
4. Require supplemental oxygen for daily activities.
5. Documented Grade ≥ 2 peripheral neuropathy.
6. History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, corneal disease that prevents/delays corneal healing, macular degeneration.
7. Subjects previously treated with TROP 2 targeted therapies.
8. Any standard cancer therapy (e.g. chemotherapy, hormonal therapy, radiotherapy, immunotherapy, biologic therapy treatment, or therapy with traditional Chinese medicines approved for anti-tumor treatment, etc.) within 4 weeks or five half-lives, whichever is shorter, of first infusion of study drug.
9. Any experimental therapy within 4 weeks or five half-lives, whichever is shorter, of first infusion of study drug.
10. Any major surgical procedure within 4 weeks of first infusion of study drug.
11. Diagnosed active liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis.
12. Have known prior positive test results or medical history for human immunodeficiency virus.
13. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) or diabetes (HbA1c ≥ 9.0%).
14. Subjects who require use of strong inhibitors or inducers of CYP3A4 at least 14 days prior to and throughout Study. Use of strong inhibitors or inducers of CYP3A4 is not allowed in this study. List of representative examples of strong inhibitors or inducers of CYP3A4 is provided in Appendix III.
15. Pregnancy or lactation.
16. Left ventricular ejection fraction \< 45% determined by echocardiogram or multiple gated acquisition scan.
17. Resting QTc \> 480 msec at baseline.
18. Ascites requiring paracentesis ≥1 per week.
19. Symptomatic pleural effusion (\< 90% oxygen saturation).
20. Subjects with non-infectious interstitial lung diseases (ILD) or medical history of pneumonia requiring steroid treatments; severe pulmonary dysfunction caused by lung diseases.
21. New diagnosed thromboembolic events that requires therapeutic intervention over the last 6 months (patients with stable control of lower limb deep venous thrombosis are allowed).
22. The investigator considers other situations that patients are not appropriate to participate in this trial.

Phase II:

1. Any patient who was treated in the Phase I part of this study.
2. Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure (New York Heart Association) III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 6 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia).
3. Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or other active CNS metastases.
4. Patients with active second primary cancers (except for cured in situ non-melanoma skin cancer and in situ cervical cancer with no relapse in the last 3 years, or other malignant cancers that have been cured and no evidence of recurrence).
5. Require supplemental oxygen for daily activities.
6. Documented Grade ≥ 2 peripheral neuropathy.
7. History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, corneal disease that prevents/delays corneal healing, macular degeneration.
8. Patients previously treated with TROP 2 targeted therapies at any time for early stage or metastatic disease.
9. Any standard cancer therapy (e.g. chemotherapy, hormonal therapy, radiotherapy, immunotherapy, biologic therapy treatment, or therapy with traditional Chinese medicines approved for anti-tumor treatment, etc.) within 4 weeks or 5 half-lives, whichever is shorter, of first infusion of study drug.
10. Any experimental therapy within 4 weeks or 5 half-lives, whichever is shorter, of first infusion of study drug.
11. Any major surgical procedure within 4 weeks of first infusion of study drug.
12. Diagnosed active liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis.
13. Have known prior positive test results or medical history for human immunodeficiency virus.
14. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) or diabetes (HbA1c ≥ 9.0%).
15. Subjects who require use of strong inhibitors or inducers of CYP3A4 at least 14 days prior to and throughout Study. Use of strong inhibitors or inducers of CYP3A4 is not allowed in this Study. List of representative examples of strong inhibitors or inducers of CYP3A4 is provided in Appendix III.
16. Pregnancy or lactation.
17. Left ventricular ejection fraction \< 45% determined by echocardiogram or multiple gated acquisition scan.
18. Resting QTcF \> 480 msec at baseline.
19. Ascites requiring paracentesis \>1 per week.
20. Symptomatic pleural effusion (\< 90% oxygen saturation).
21. History of interstitial lung diseases (ILD) or non-infectious pneumonitis requiring steroid treatments; severe pulmonary dysfunction caused by lung diseases.
22. New diagnosed thromboembolic events that requires therapeutic intervention over the last 6 months (patients with stable control of lower limb deep venous thrombosis are allowed).
23. Known allergic to any components of SKB264, including excipients (including polysorbate-20); or history of severe hypersensitivity to another biologic therapy.
24. The investigator considers other situations that patients are not appropriate to participate in this trial.

Primary outcomes:
measure: Phase I: Maximum Tolerated Dose (MTD) and Recommended Doses for Expansion (RDEs)
timeFrame: Assess up to 12 months
measure: Phase II: Objective Response Rate (ORR)
timeFrame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary outcomes:
measure: Phase I: Dose Limiting Toxicities (DLTs)
timeFrame: Day 28 days after first infusion of study drug
measure: Phase I: Overall safety and tolerability profile
timeFrame: from the date of informed consent until 30 days after last infusion of study drug or begin a new anti cancer therapy, whichever occurs first
measure: Phase I: Preliminary efficacy based on ORR (Objective Response Rate)
timeFrame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, approximately 12 months
measure: Phase I: Preliminary efficacy based on DOR(Duration of Response)
timeFrame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, approximately 12 months
measure: Phase I: Preliminary efficacy based on PFS(Progression-Free Survival)
timeFrame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, approximately 12 months
measure: Phase I: Preliminary efficacy based on OS(Overall Survival)
timeFrame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, approximately 12 months
measure: Phase I: Percentage of patients with ADA formation to SKB264.
timeFrame: From Cycle 1 to Cycle 6 and End of Treatment(EOT), approximately 12 months
measure: Phase I: PK parameters for SKB264-ADC, SKB264 TAB, and free KL610023 payload.
timeFrame: From Cycle 1 to Cycle 6 and End of Treatment(EOT), approximately 12 months
measure: Phase II: Overall safety and tolerability profile
timeFrame: from the date of informed consent until 30 days after last infusion of study drug or begin a new anti cancer therapy, whichever occurs first
measure: Phase II: Efficacy based on DOR (Duration of Response)
timeFrame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, approximately 12 months.
measure: Phase II: Efficacy based on PFS (Progression-Free Survival)
timeFrame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, approximately 12 months.
measure: Phase II: Efficacy based on OS (Overall Survival)
timeFrame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, approximately 12 months.
measure: Phase II: Percentage of patients with ADA formation to SKB264.
timeFrame: From Cycle 1 to Cycle 6 and End of Treatment(EOT), approximately 12 months
measure: Phase II: PK parameters for SKB264-ADC, SKB264 TAB, and free KL610023 payload
timeFrame: From Cycle 1 to Cycle 6 and End of Treatment(EOT), approximately 12 months
measure: Phase II: Levels of TROP2 expression in tumor tissue
timeFrame: Screening and End of Treatment(EOT), approximately 12 months
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Los Angeles Hematology Oncology Medical Group
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Sarasota
country: United States
facility: Florida Cancer Specialists and Research Institute
state: Florida
city: Grand Rapids
country: United States
facility: START MidWest
state: Michigan
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute, LLC
state: Oklahoma
city: Portland
country: United States
facility: Providence Cancer Institute, Franz Clinic
state: Oregon
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Montreal
country: Canada
facility: MUHC,Glen - Women's Health Research Unit
state: Quebec
city: Providencia
country: Chile
facility: Centro de Estudios Clínicos SAGA
city: Santiago
country: Chile
facility: Centro de Investigacion Clinica Bradford Hill
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile - CICUC
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical University
state: Anhui
city: Hefei
country: China
facility: Anhui Cancer Hospital
state: Anhui
city: Hefei
country: China
facility: AnHui Provincial Cancer Hospital
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC Anhui Provincial Hospital
state: Anhui
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Obstetrics and Gynecology Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital (301 Hospital)
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Chongqing
country: China
facility: Chongqing University Cancer Hosptital
state: Chongqing
city: Fuzhou
country: China
facility: 900TH Hospital of Joint Logistics Support Force
state: Fujian
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Medical University Uion Hospital
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital Of Xiamen University
state: Fujian
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Affiliated Hospital of Guangdong Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital , Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer prevention Center
state: Guangdong
city: Guilin
country: China
facility: The Second Affiliated Hospital of Guilin Medical University
state: Guangxi
city: Nanning
country: China
facility: Guangxi Medical University Cancer Center
state: Guangxi
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Haikou
country: China
facility: The First Affiliated Hospital of Hainan Medical University
state: Hainan
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Anyang
country: China
facility: Anyang City Cancer Hospital
state: Henan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Nanyang
country: China
facility: Nanyang Center Hospital
state: Henan
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical College
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou Central Hospital
state: Henan
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College Huazhong University Of Science And Technology
state: Hubei
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University Of Science And Technology
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union Hospital of China
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Lianyungang
country: China
facility: The first people's hospital of Lianyungang
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Binzhou
country: China
facility: Affiliated Hospital of Binzhou Medical College
state: Shandong
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical College
state: Shandong
city: Weifang
country: China
facility: Weifang People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Obstetrics&Gynecology Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Neijiang
country: China
facility: Neijiang Second People's Hospital
state: Sichuan
city: Yibin
country: China
facility: Yibin Second People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang University School of Medical Sir Run Run Shaw Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Yenimahalle
country: Turkey
facility: Gazi University Medical Faculty
state: Ankara
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jordi Rodon Ahnert, MD, PhD
role: STUDY_CHAIR
References: