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

StatusRecruiting
PhasePhase 1/2
Started2025-04-11
View on ClinicalTrials.gov ↗

Amendment history

2026-01-27
Study Status, Study Design v3
Enrollment target400→436
2025-11-14
Study Status, Study Design, Arms and Interventions, Eligibility v2
PhasePhase 1→Phase 1/2
Enrollment target270→400
InterventionsJMT108 (Drug)→Ivonescimab (Drug), JMT108 (Drug), Pembrolizumab (Drug)
Eligibility criteria+331 characters
[...] ll 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. Participants with at least one evaluable tumor lesion in the [...] three months after radiotherapy) according to RECIST v1.1. Stage I: ECOG performance statusscore ≤ 2. Stage II: ECOG performance score ≤2.0-1 Expected survival ≥ 3 months. Adequate organ f [...]
2025-04-29
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-03-30→confirmed 2025-04-11
Study sites0→1
2025-03-11
Original filing
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.
Trial Details
NCT Number NCT06877650
Lead Sponsor Shanghai JMT-Bio Inc.
Conditions Advanced Malignant Tumors
Enrollment 436 participants
Start Date 2025-04-11
Primary Completion 2028-03-30 (estimated)
Study Completion 2029-03-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-29