- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04689100
Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor
A Phase I, Open Label, Multi-center Study to Assess the Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor.
Study Overview
Detailed Description
The objective of the trial is to evaluate the safety and efficacy of JMT101 in patients with advanced solid tumor.
This study consists of two parts (Stage I and Stage II). Stage I was a dose escalation study, and Stage II was a dose expansion study.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Xiugao Yang
- Phone Number: 8021-60677906
- Email: yangxiugao@mail.ecspc.com
Study Contact Backup
- Name: Rong Hu
- Phone Number: 8021-60673935
- Email: hurong@mail.ecspc.com
Study Locations
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-
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Beijing, China
- Recruiting
- Peking University Cancer Hospital
-
Contact:
- Lin Shen
- Phone Number: 8010-88196561
- Email: linshenpku@163.com
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Beijing, China
- Recruiting
- Beijing Luhe Hospital. Capital Medical University
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Bengbu, China
- Recruiting
- The First Affiliated Hospital of Bengbu Medical College
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Principal Investigator:
- Jun Qian
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Contact:
- Jun Qian
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Principal Investigator:
- Huan Zhou
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Changzhou, China
- Recruiting
- The First People's Hospital of Changzhou
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Contact:
- Wenwei Hu
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Chongqing, China
- Recruiting
- Chongqing University Cancer Hospital
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Contact:
- Weiqi Nian
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Guangzhou, China
- Recruiting
- The Sixth Affiliated Hospital, Sun Yat-sen University
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Shanghai, China
- Recruiting
- Zhongshan Hospital
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Suzhou, China
- Recruiting
- The First Affiliated Hospital of Soochow University
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Contact:
- Weichang Chen
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Zhengzhou, China
- Not yet recruiting
- Henan Cancer Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Monotherapy: Pathologically or cytologically confirmed, advanced solid tumor, harboring RAS wild type; Combined with chemotherapy: Pathologically or cytologically confirmed, locally advanced /metastatic colorectal cancer, harboring RAS and BRAF V600E wild type.
- At least 1 measurable lesion according to RECIST 1.1;
- ECOG score 0 or 1;
- Stable for more than 14 days of brain metastasis or spinal cord compression.
Exclusion Criteria:
- Receipt of any EGFR inhibitors within 5 months prior to the first dose of study treatment.
- The second primary malignant tumor was diagnosed within 5 years prior to the first dose of study treatment.
- Known hypersensitivity to any ingredient of JMT101 or their excipients;
- Major surgery within prior 4 weeks of first treatment.
- Receiving an investigational product in another clinical study within 4 weeks;
- History of serious systemic diseases;
- Pregnancy or lactating wo
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dose Expansion Cohort
Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.
|
Monotherapy: Accelerated titration method, IV infusion QW; Conventional 3 + 3 study design, IV infusion Q2W.
(28-day cycles) Combined with chemotherapy: Conventional 3 + 3 study design, IV infusion Q2W.
(28-day cycles)
Other Names:
IV infusion Q2W (28-day cycles)
Other Names:
|
Experimental: Dose Escalation Cohort
Monotherapy: Six dose levels of JMT101 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design. Combined with chemotherapy: Three dose levels of JMT101 will be tested by a conventional 3 + 3 study design. The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days). |
Monotherapy: Accelerated titration method, IV infusion QW; Conventional 3 + 3 study design, IV infusion Q2W.
(28-day cycles) Combined with chemotherapy: Conventional 3 + 3 study design, IV infusion Q2W.
(28-day cycles)
Other Names:
IV infusion Q2W (28-day cycles)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum Tolerated Dose (MTD)
Time Frame: 28 days
|
28 days
|
Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 4.03 (CTCAE V4.03)).
Time Frame: From enrollment until 30 days after the last dose
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From enrollment until 30 days after the last dose
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Number of Subjects Experiencing DLTs (Dose Limiting Toxicity).
Time Frame: Time from the first dose of study drug up to 4 weeks
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Time from the first dose of study drug up to 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease control rate (DCR).
Time Frame: From first dose to disease progression or end of study, an average of 1 year
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From first dose to disease progression or end of study, an average of 1 year
|
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Progression free survival (PFS).
Time Frame: From first dose to disease progression or end of study, an average of 1 year
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From first dose to disease progression or end of study, an average of 1 year
|
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Overall survival (OS).
Time Frame: From first dose to death or end of study, an average of 1 year
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From first dose to death or end of study, an average of 1 year
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Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of JMT101.
Time Frame: From enrollment until 30 days after the last dose
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From enrollment until 30 days after the last dose
|
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Maximum measured plasma concentration (Cmax) of JMT101.
Time Frame: From enrollment until 30 days after the last dose
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From enrollment until 30 days after the last dose
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Time to maximum plasma concentration (Tmax) of JMT101.
Time Frame: From enrollment until 30 days after the last dose
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From enrollment until 30 days after the last dose
|
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Half-life (T1/2) of JMT101.
Time Frame: From enrollment until 30 days after the last dose
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From enrollment until 30 days after the last dose
|
|
Objective Response Rate (ORR)
Time Frame: From first dose to disease progression or end of study, an average of 1 year
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From first dose to disease progression or end of study, an average of 1 year
|
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Immunogenicity profile of JMT101.
Time Frame: From enrollment until 30 days after the last dose
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Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies(ADA) and neutralizing antibodies by electrochemical luminescence(ECL).
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From enrollment until 30 days after the last dose
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Potential biomarkers detected in plasma or tumor issue DNA.
Time Frame: From enrollment up to disease progression, an average of 1 year
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The content of RAS(reticular activating system), EGFR(epidermal growth factor receptor), BRAF(B-Raf proto-oncogene) gene will be detected.
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From enrollment up to disease progression, an average of 1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Xiugao Yang, Department of Medicine, CSPC Clinical Development Division
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Topoisomerase Inhibitors
- Micronutrients
- Vitamins
- Calcium-Regulating Hormones and Agents
- Topoisomerase I Inhibitors
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Oxaliplatin
- Leucovorin
- Irinotecan
- Calcium
- Levoleucovorin
Other Study ID Numbers
- JMT101-ECL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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