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NCT06877650PHASE1, PHASE2RECRUITING

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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Key Facts

Study type
INTERVENTIONAL
Conditions
Advanced Malignant Tumors
Interventions
JMT108, Pembrolizumab, Ivonescimab
Enrollment
436 participants
Primary completion
Mar 2028
Study completion
Mar 2029
First posted
Mar 2025
Last updated
Jan 2026

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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Source

Open on ClinicalTrials.gov