First-in-Human Investigation of JMT108 Injection in Participants With Advanced Malignant Tumors

Sponsor
Shanghai JMT-Bio Inc.
Study ID
NCT06877650
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Malignant Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JMT108 — DRUG
    Intravenous (IV) administration every three weeks (D1) in a 3-week cycle.
  • Pembrolizumab — DRUG
    Intravenous (IV) administration every three weeks (D1) in a 3-week cycle.
  • Ivonescimab — DRUG
    Intravenous (IV) administration every three weeks (D1) in a 3-week cycle.

Study Details

This study is designed as an open-label, multi-center Phase 1 clinical study in participants with advanced malignant tumors to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor activity of JMT108 injection, and to determine the RP2D/schedule for subsequent studies.

Key Dates

Start date
Apr 11, 2025
Status verified
Apr 2025
Primary completion
Mar 30, 2028
Completion
Mar 30, 2029

Study Design

Enrollment
436 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: JMT108

Primary Outcome Measure

Dose-Limiting Toxicity(DLT) [ Time Frame: Approximately 28 days. ]

Central Contacts

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