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

Phase 1

Recruiting

• Conditions: Solid Tumor
• Interventions: Drug: GT90001+KN046; Drug: GT90001/KN046

• Registration Number: NCT04984668
• Lead Sponsor: Suzhou Kintor Pharmaceutical Inc,

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-21
• Study First Posted: 2021-07-30
• Study Start: 2021-11-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-09
• Primary Completion: 2025-04
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GT90001+KN046	GT90001/KN046	GT90001, 100 mg/10 mL/vial. GT90001 will be administered via intravenous infusion (IV) for around 60 minutes, once every 2 weeks (Q2W) in each 14-day cycle. KN046, 40 mg/1.6 mL/vial, 300 mg/12 mL/vial KN046 will be administered via intravenous infusion (IV) for at least 120 minutes (up to 4h for the first 6 cycles), once every 2 weeks (Q2W) in each 14-day cycle, after 60 minutes post the GT90001 taken.
GT90001+KN046	GT90001+KN046	GT90001, 100 mg/10 mL/vial. GT90001 will be administered via intravenous infusion (IV) for around 60 minutes, once every 2 weeks (Q2W) in each 14-day cycle. KN046, 40 mg/1.6 mL/vial, 300 mg/12 mL/vial KN046 will be administered via intravenous infusion (IV) for at least 120 minutes (up to 4h for the first 6 cycles), once every 2 weeks (Q2W) in each 14-day cycle, after 60 minutes post the GT90001 taken.

Primary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events (TEAEs), treatment-related AEs (TRAEs), serious adverse events (SAEs), Dose Limiting Toxicities (DLTs)	until progression or death,whichever came first, assessed up to 2 years	safety
Phase 2 dose (RP2D) of GT90001 in combination with KN046	after completion of the DLT evaluation of the last subject of Phase Ib, up to 28 days	RP2D
Objective response rate	until progression or death,whichever came first, assessed up to 2 years	Efficacy

Secondary Outcome Measures

Name	Time	Method
ORR (Phase Ib) in %, disease control rate (DCR) in %, progression-free survival (PFS)in months, and duration of response (DoR) in %	until progression or death,whichever came first, assessed up to 2 years	Efficacy
TEAEs, severity of TEAEs, TRAEs, SAEs	until progression or death,whichever came first, assessed up to 2 years	safety
occurrence of anti-GT90001 and anti-KN046 antibody	until progression or death,whichever came first, assessed up to 2 years	immunogenecity
AUC0-t, Cmax, Tmax, t½ , CLss for GT90001 , Ctroug for KN046 (only Phase Ib)	until progression or death,whichever came first, assessed up to 2 years	Pharmacokinetic evaluations

Trial Locations

Locations (1)

Chi-Mei Medical Center; 🇨🇳 Tainan, Taiwan