First-in-Human Investigation of JMT108 Injection in Participants With Advanced Malignant Tumors
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JMT108 Injection in Participants With Advanced Malignant Tumors.
Sponsor: Shanghai JMT-Bio Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Dose-Limiting Toxicity(DLT)
Time frame: Approximately 28 days.
Adverse Events (AEs)
Time frame: through study completion, an average of 1 year
Secondary Endpoints
Maximum plasma concentration (Cmax)
Eligibility Criteria
Inclusion Criteria: 1. Fully informed of the study, with good compliance and willing to provide written informed consent. 2. Male or female participants aged ≥18 years (at the time of obtaining informed consent). 3. Participants with histologically or cytologically confirmed advanced malignant tumors who are unresponsive or intolerant to all standard of care, or have no standard of care available. For locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC without sensitive gene mutations, participants who have not received systemic treatment in the advanced stage and are unwilling to accept the current standard treatment can also be enrolled in the cohort expansion phase. 4. Participants with at least one evaluable tumor lesion in the Phase 1a dose-escalation phase; and at least one measurable lesion in the Phase 1a dose-expansion phase and Phase 1b (tumor lesions in the past radiation fields or that underwent locoregional therapy are generally not considered measurable les…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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