A Phase Ib/II, Multicenter Study of GT90001 in Combination With KN046 in Patients With Advanced or Refractory Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- GT90001+KN046
- Conditions
- Solid Tumor
- Sponsor
- Suzhou Kintor Pharmaceutical Inc,
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Treatment-emergent adverse events (TEAEs), treatment-related AEs (TRAEs), serious adverse events (SAEs), Dose Limiting Toxicities (DLTs)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: 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.
Intervention: GT90001/KN046
Outcomes
Primary Outcomes
Treatment-emergent adverse events (TEAEs), treatment-related AEs (TRAEs), serious adverse events (SAEs), Dose Limiting Toxicities (DLTs)
Time Frame: until progression or death,whichever came first, assessed up to 2 years
safety
Phase 2 dose (RP2D) of GT90001 in combination with KN046
Time Frame: after completion of the DLT evaluation of the last subject of Phase Ib, up to 28 days
RP2D
Objective response rate
Time Frame: until progression or death,whichever came first, assessed up to 2 years
Efficacy
Secondary Outcomes
- 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)
- TEAEs, severity of TEAEs, TRAEs, SAEs(until progression or death,whichever came first, assessed up to 2 years)
- occurrence of anti-GT90001 and anti-KN046 antibody(until progression or death,whichever came first, assessed up to 2 years)
- 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)