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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04805307
Other study ID # KYM901
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date December 24, 2020
Est. completion date October 2024

Study information

Verified date December 2022
Source Keymed Biosciences Co.Ltd
Contact Qian Jia
Phone 028-88610620
Email qianjia@keymedbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multi-center, open-label, dose escalation and dose expansion, Phase 1 study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of CMG901. The dose escalation part (Part A) will determine the MTD of CMG901 in subjects with relapsed and/or refractory advanced solid tumor for which there is no available standard therapy likely to confer clinical benefit, or the subject is not a candidate for such available therapy based on a modified 3+3 dose escalation design (an accelerated dose titration design followed by traditional 3+3 dose escalation design). The dose expansion part (Part B) will evaluate the preliminary anti-tumor activity and safety of CMG901 in subjects with Claudin 18.2 positive gastric cancer (GC), gastroesophageal junction (GEJ) cancer, and pancreatic cancer who have relapsed and/or are refractory to approved therapies.


Recruitment information / eligibility

Status Recruiting
Enrollment 162
Est. completion date October 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Key Inclusion Criteria: - Part A: Patient must have histologically or cytologically confirmed advanced and/or metastatic solid tumor malignancies for which standard treatment do not exist, are no longer effective, or are not acceptable to the patient. - Part A: Must provide archival tumor tissue specimen or agree to undergo a fresh biopsy if archival specimen is unavailable for retrospective Claudin 18.2 testing prior to enrollment; Claudin 18.2 expression is not required for enrollment. - Part A: Measurable or evaluable disease per RECIST v 1.1. - Part B: Histologically-confirmed, advanced unresectable or metastatic GC, GEJ adenocarcinoma, or pancreatic cancer which have relapsed and/or are refractory to approved therapies. - Part B: CLDN18.2-positive tumor sample assessed by central testing. New biopsies and archival bio-samples are allowed. If archival tissue samples from several points of time are available, the most recent one is preferred. - Part B: Measurable disease per RECIST v 1.1. - Women of childbearing potential and male subjects must agree to remain abstinent or use contraceptive methods as defined by the protocol. - Eastern Cooperative Oncology Group Performance Status 0-1. - Side effects of any prior therapy or procedures for any medical condition has recovered to NCI-CTCAE v.5.0 Grade = 1 or stable status by investigator. Key Exclusion Criteria: - Received: chemotherapy or any investigational anti-tumor agents within 28 days of the start of CMG901 treatment; molecularly-targeted agents, immunoconjugate, or antibody drug conjugate within 28 days or or 5 half-lives (whichever is shorter) of the start of CMG901 treatment; major surgery within 28 days of the start of CMG901 treatment; radiotherapy within 21 days of the start of CMG901 treatment; potent cytochrome P450 3A4 (CYP3A4) inhibitors within 14 days or or 5 half-lives (whichever is longer) of the start of CMG901 treatment. - Diagnosis of immunodeficiency or requiring another form of chronic immunosuppressive therapy. Or is receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone or equivalent) within 7 days prior to the first dose. - History of severe hypersensitivity to any component or excipient of CMG901. - Ongoing or active infection assessed by investigator. - Any severe cardiac dysfunction including left ventricular ejection fraction <50%, congestive heart failure =Grade 2 (New York Heart Association), QTc >480 msec, history of acute myocardial infarction, angina pectoris, uncontrolled arrhythmia, acute coronary syndromes, stent placement, stroke, or transient ischemic attack within 6 months of enrollment. - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. - Subjects with uncontrolled ascites, pleural effusion, or pericardial effusion by investigator. - Preexisting sensory and/or motor neuropathy Grade =2. - Uncontrolled diabetes mellitus or diabetic neuropathy within 3 months of the first dose of CMG901. - Known infection with HIV, or HIV positive; Known active hepatitis B, or HBsAg positive with HBV-DNA positive, or anti-HBc positive with HBV-DNA positive; Known active hepatitis C, or anti-HCV antibody positive with HCV-RNA positive. - Any severe and/or uncontrolled systemic disease or other conditions that in the opinion of the Investigator make the subject unsuitable for participation in this study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CMG901
CMG901 will be administered intravenously (IV) on Day 1 of every 21-day cycle. Individual subjects may continue study treatment until there is evidence of disease progression (clinical or radiologic) judged by Investigators, unacceptable toxicity or other reasons for treatment discontinuation.

Locations

Country Name City State
China Affiliated Hospital of Hebei University Baoding
China Hunan Cancer Hospital Changsha
China Sichuan Cancer Hospital Chengdu
China West China Hospital of Sichuan University Chengdu Sichuan
China Chongqing University Cancer Hospital Chongqing
China Fujian Cancer Hosppital Fuzhou
China Fujian Medical University Union Hospital Fuzhou
China The First Affiliated Hospital of Fujian Medical University Fuzhou
China Guangdong Provincial People's Hospital Guangzhou
China Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou
China Sun Yat-sen University Cancer Center (SYSUCC) Guangzhou Guangdong
China The First Affiliated Hospital, Sun Yat-sen University Guangzhou
China Hainan General Hospital Haikou
China The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou
China Harbin Medical University Cancer Hospital Harbin
China The Second Hospital of Anhui Medical University Hefei
China Affiliated Hospital of Jining Medical University Jining
China Lanzhou University Second Hospital Lanzhou
China The First Affiliated Hospital of Henan University of science and Technology Luoyang
China Meizhou People's Hospital Meizhou
China Jiangxi Cancer Hospital Nanchang
China Huashan Hospital, Fudan University Shanghai
China Liaoning Cancer Hospital & Institute Shenyang
China The First Hospital of China Medical University Shenyang
China The Forth Hospital of Hebei Medical University and Hebei Tumor Hospital Shijiazhuang
China The Second Affiliated Hospital of Soochow University Suzhou
China Hubei Cancer Hospital Wuhan
China Tongji Hospital Tongji Medical College of HUST Wuhan
China The First Affiliated Hospital of Xiamen University Xiamen
China The Affiliated Hospital of Xuzhou Medical University Xuzhou
China Henan Cancer Hospital Zhengzhou Henan
China The First Affiliated Hospital of Zhengzhou University Zhengzhou

Sponsors (1)

Lead Sponsor Collaborator
Keymed Biosciences Co.Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part A: Number of Participants with a Dose-Limiting Toxicity (DLT) Up to 21 days after the first dose
Primary Part A: Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 Up to 30 days after the last dose of CMG901 or until the start of subsequent anticancer therapy, if earlier
Primary Part B: Objective Response Rate, Assessed According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Up to 24 months
Primary Part B: Recommended phase II dose Up to 24 months
Secondary Part A & Part B: AUC to the last quantifiable concentration [AUC(0-last)], over the dosing interval [AUC(0-tau)], extrapolated to infinity [AUC(0-inf), time to Cmax (tmax), apparent half-life (t1/2), systemic clearance (CL). 21 days after the first dose
Secondary Part A & Part B: AUC(0-last), AUC(0-tau), Cmax, tmax, t1/2, systemic clearance (CL), volume of distribution (Vz, Vss), minimum concentration (Cmin), Ctrough, accumulation ratios for Cmax and AUC(0-tau) for multiple doses up to 24 months
Secondary Part A & Part B: Incidence of anti-CMG901 up to 24 months
Secondary Part A & Part B: Disease Control Rate, Assessed According to RECIST v1.1 up to 24 months
Secondary Part A & Part B: Duration of Response, Assessed According to RECIST v1.1 up to 24 months
Secondary Part A & Part B: Progression Free Survival, Assessed According to RECIST v1.1 up to 24 months
Secondary Part A: Claudin 18.2 expression by retrospective testing in tumor specimens by immunohistochemistry up to 24 months
Secondary Part A: ORR, Assessed according to RECIST 1.1 Up to 24 months
Secondary Part A & Part B: Overall Survival Up to 24 months
Secondary Part B: Incidence, severity, and outcome of TEAEs and SAEs based on NCI CTCAE version 5.0 Up to 24 months
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