Phase 1/2 Study of TSN1611 in Subjects With Advanced Solid Tumors Harboring KRAS G12D Mutation
Tyligand Pharmaceuticals (Suzhou) Limited
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. This study will evaluate the efficacy of TSN1611 at RP2D(s) through ORR using RECIST version 1.1, and determine and confirm the MTD/RP2D for TSN1611 in combination with cetuximab, in combination with cetuximab and mFOLFOX6, in combination with gemcitabine and albumin-bound paclitaxel in subjects with selected solid tumors.
Description
Phase 1 Part of TSN1611 Monotherapy: 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 of TSN1611 Monotherapy: hase 2 part of TSN1611 monotherapy will evaluate the efficacy and safety of TSN1611 as monotherapy at the RP2D until disease progression or unacceptable toxicity in separate groups of patients with pancreatic cancer, colorecta…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Subjects must meet all the following inclusion criteria to be eligible for participation in this study: * The subject fully understands the requirements of the study and voluntarily signs the ICF. * At least 18 years of age at the time of informed consent.≤ 75 years of age for Cohort B and C. * Life expectancy of 3 months or more. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Phase 1 part (1a/1b) of Monotherapy: Subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumor harboring KRAS G12D mutation; subjects must be refractor…
Interventions
- DrugTSN1611
TSN1611 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.
- DrugTSN1611
TSN1611 BID, Cetuximab will be administered via intravenous infusion at a dose of 500 mg/m² every 2 weeks.
- DrugTSN1611
TSN1611 BID, Paclitaxel (albumin-bound) at 125 mg/m² and gemcitabine at 1000 mg/m² will be administered via intravenous infusion on Days 1, 8, and 15 of each 4-week cycle.
- DrugTSN1611
TSN1611 BID everyday and Patients will be administered with mFOLFOX6 on Days 1 and 2, every 2 weeks.
Locations (19)
- MD Anderson Cancer CenterHouston, Texas
- NEXT OncologySan Antonio, Texas
- NEXT VirginiaFairfax, Virginia
- Anhui Provincial Cancer HospitalHefei, Anhui
- Beijing Cancer HospitalBeijing, Beijing Municipality
- The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, Guangdong