A Study of TSN1611 Treating Patients with Advanced Solid Tumors Harboring KRAS G12D Mutation
- Registration Number
- NCT06385925
- Lead Sponsor
- Tyligand Pharmaceuticals (Suzhou) Limited
- Brief Summary
The study is a first-in-human (FIH), open-label, multi-center phase 1/2 study of TSN1611 in subjects with KRAS G12D mutant advanced solid tumors. This study will consist of a phase 1 dose escalation part and phase 2 dose expansion part.
- Detailed Description
Phase 1 Part:
The phase 1 part will evaluate the prespecified dose levels of TSN1611. Dose escalation will continue until up to the highest planned dose or the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is determined. Dose optimization could be performed as indicated by the emerging data.
Phase 2 Part:
Phase 2 part will evaluate the efficacy and safety of TSN1611 as monotherapy at the recommended dose in separate groups of patients with pancreatic cancer, colorectal cancer, non-small cell lung cancer, or other solid tumors, harboring KRAS G12D mutations.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 1: Dose-finding/evaluation of TSN1611 monotherapy TSN1611 The phase 1 part will evaluate the prespecified sequential dose levels of TSN1611 in subjects with KRAS G12D mutant advanced solid tumors to determine the recommended dose of TSN1611 for further investigation. Phase 2: Dose expansion of TSN1611 monotherapy TSN1611 Phase 2 part will evaluate the efficacy and safety of TSN1611 as monotherapy at the recommended dose level in separate groups of patients with pancreatic cancer, colorectal cancer, non-small cell lung cancer, or other solid tumors, harboring KRAS G12D mutations.
- Primary Outcome Measures
Name Time Method Dose limiting toxicities (DLTs) in phase 1 part 21 days To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose(s) (RP2D\[s\]) of TSN1611 as monotherapy in subjects with KRAS G12D mutant advanced solid tumors.
Objective response rate (ORR) in phase 2 part Up to 3 years To evaluate the anti-tumor activity of TSN1611 using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Secondary Outcome Measures
Name Time Method Progression free survival (PFS) Up to 3 years To evaluate the anti-tumor activity of TSN1611 using RECIST version 1.1.
Adverse events Up to 3 years To assess the safety profile and tolerability of TSN1611 as monotherapy in subjects with KRAS G12D mutant advanced solid tumors.
Maximum blood concentrations (Cmax) 9 weeks To characterize the PK profile of TSN1611.
Duration of response (DOR) Up to 3 years To evaluate the anti-tumor activity of TSN1611 using RECIST version 1.1.
Overall survival Up to 3 years Area under the plasma concentration-time curve (AUC) 9 weeks To characterize the pharmacokinetic (PK) profile of TSN1611.
Time to maximum blood concentration (Tmax) 9 weeks To characterize the PK profile of TSN1611.
Time to response (TTR) Up to 3 years To evaluate the anti-tumor activity of TSN1611 using RECIST version 1.1.
Disease control rate (DCR) Up to 3 years To evaluate the anti-tumor activity of TSN1611 using RECIST version 1.1.
Trial Locations
- Locations (6)
MD Anderson Cancer Center
πΊπΈHouston, Texas, United States
NEXT Oncology
πΊπΈSan Antonio, Texas, United States
NEXT Virginia
πΊπΈFairfax, Virginia, United States
Beijing Cancer Hospital, Beijing, China
π¨π³Beijing, China
Shanghai Chest Hospital, Shanghai, China
π¨π³Shanghai, China
Shanghai Zhongshan Hospital, Shanghai, China
π¨π³Shanghai, China