A Phase I, Open Label, Multi-center Study to Assess the Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor.
Overview
- Phase
- Phase 1
- Intervention
- JMT101
- Conditions
- Advanced Solid Tumor
- Sponsor
- Shanghai JMT-Bio Inc.
- Enrollment
- 259
- Locations
- 9
- Primary Endpoint
- Maximum Tolerated Dose (MTD)
- Last Updated
- 5 years ago
Overview
Brief Summary
This study is a Phase I, open label, multi-center study of to evaluate the safety and efficacy of JMT101 in patients with advanced solid tumor.
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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).
Intervention: JMT101
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.
Intervention: JMT101
Outcomes
Primary Outcomes
Maximum Tolerated Dose (MTD)
Time Frame: 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
Number of Subjects Experiencing DLTs (Dose Limiting Toxicity).
Time Frame: Time from the first dose of study drug up to 4 weeks
Secondary Outcomes
- Disease control rate (DCR).(From first dose to disease progression or end of study, an average of 1 year)
- Overall survival (OS).(From first dose to death or end of study, an average of 1 year)
- Objective Response Rate (ORR)(From first dose to disease progression or end of study, an average of 1 year)
- Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of JMT101.(From enrollment until 30 days after the last dose)
- Maximum measured plasma concentration (Cmax) of JMT101.(From enrollment until 30 days after the last dose)
- Half-life (T1/2) of JMT101.(From enrollment until 30 days after the last dose)
- Progression free survival (PFS).(From first dose to disease progression or end of study, an average of 1 year)
- Time to maximum plasma concentration (Tmax) of JMT101.(From enrollment until 30 days after the last dose)
- Immunogenicity profile of JMT101.(From enrollment until 30 days after the last dose)
- Potential biomarkers detected in plasma or tumor issue DNA.(From enrollment up to disease progression, an average of 1 year)