NCT07230977

GenSci139 in Patients With Advanced Solid Tumors

A Phase I, Two-Part, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activities of GenSci139 in Patients With Locally Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I, two-part, multicenter, first-in-human study. The Part 1 study will assess the safety, tolerability, preliminary anti-tumor activities, PK profile, immunogenicity and biomarker of GenSci139 in participants with locally advanced or metastatic solid tumors, as well as identity MTD (if any) and RDE. The Part 2 study is to further evaluate the preliminary anti-tumor activities, safety, PK profile, immunogenicity and biomarker of GenSci139 at RDE dose levels with selected advanced cancers.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	GenSci139	GenSci139 is a bispecific antibody drug conjugate targeting EGFR and HER2.

Timeline

• Start date: 2025-11-19
• Primary completion: 2028-07-07
• Completion: 2029-01-08
• First posted: 2025-11-17
• Last updated: 2025-12-24

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study