NCT04984668

A Phase Ib/II Study of GT90001 Combined With KN046 in Solid Tumors

A Phase Ib/II, Multicenter Study of GT90001 in Combination With KN046 in Patients With Advanced or Refractory Solid Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Suzhou Kintor Pharmaceutical Inc, · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase Ib is a dose De-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumor activity of GT90001 in combination with KN046 in subjects with advanced or refractory hepatocellular carcinoma (HCC), gastric carcinoma (GC) and gastroesophageal junction (GEJ) adenocarcinoma, urothelial carcinoma (UC) and esophageal square cell carcinoma (ESCC). Phase II is to investigate anti-tumor efficacy of GT90001 in combination with KN046 at RP2D in subjects with specific types of tumors. A Simon two-stage design is planned for each indication in order to minimize the number of treated participants if there is minimal efficacy activity in that indication.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	GT90001+KN046	GT90001 7.0mg/Kg， KN046 5mg/Kg
DRUG	GT90001+KN046	GT90001 7.0mg/Kg ， KN046 3mg/Kg
DRUG	GT90001/KN046	GT90001 4.5mg/Kg / KN046 5mg/Kg
DRUG	GT90001+KN046	GT90001 4.5mg/Kg， KN046 3mg/Kg
DRUG	GT90001+KN046	GT90001 3mg/Kg ， KN046 3mg/Kg

Timeline

• Start date: 2021-11-02
• Primary completion: 2025-04-01
• Completion: 2025-12-01
• First posted: 2021-07-30
• Last updated: 2024-02-09

Locations

1 site across 1 country: Taiwan