NCT06877650

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.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 436 (estimated)
• Sponsor: Shanghai JMT-Bio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Malignant Tumors

Interventions

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

Timeline

• Start date: 2025-04-11
• Primary completion: 2028-03-30
• Completion: 2029-03-30
• First posted: 2025-03-14
• Last updated: 2026-01-29

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study