A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
Start Date
4/29/2024
Completion Date
4/30/2027
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.
Detailed 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, colorectal cancer, non-small cell lung cancer, or other solid tumors, harboring KRAS G12D mutations. Phase 1b/2 Part of TSN1611 Combination Therapy: This part will consist of the investigations of 3 combined therapies (Cohort A, B and C). In each cohort, there will be a Phase 1b Safety Lead-in Stage to determine the dose of TSN1611 for the combination therapy (this part will be conducted in selected sites), followed by the Phase 2 Expansion Stage to enroll more subjects to determine the efficacy in different cohorts.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
TSN1611
TSN1611
TSN1611
TSN1611
Conditions
Locations
MD Anderson Cancer Center
Houston, Texas 77030
United States
NEXT Oncology
San Antonio, Texas 78229
United States
NEXT Virginia
Fairfax, Virginia 22031
United States
Anhui Provincial Cancer Hospital
Hefei, Anhui
China
Beijing Cancer Hospital
Beijing, Beijing Municipality
China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
China
Hubei Cancer Hospital
Wuhan, Hubei
China
Hunan Cancer Hospital
Changsha, Hunan
China
The First Affiliated Hospital of Nanchang University - Donghu District
Nanchang, Jiang
China
Linyi Cancer Hospital
Linyi, Shandong
China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality
China
West China Hospital, Sichuan University
Chengdu, Sichuan
China
Sir Run Run Shaw Hospital - Zhejiang University School of Med
Hangzhou, Zhejiang
China
The First Affiliated Hospital - Zhejiang University School of Medicine
Hangzhou, Zhejiang
China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang
China
Beijing Cancer Hospital, Beijing, China
Beijing, 100142
China
Shanghai Chest Hospital, Shanghai, China
Shanghai, 200030
China
Shanghai Zhongshan Hospital, Shanghai, China
Shanghai, 200032
China