RecruitingPhase 1Phase 2NCT06385925

A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation

Phase 1/2 Study of TSN1611 in Subjects With Advanced Solid Tumors Harboring KRAS G12D Mutation

Sponsor

Tyligand Pharmaceuticals (Suzhou) Limited

Enrollment

440 participants

Start Date

Apr 29, 2024

Study Type

INTERVENTIONAL

Conditions

Malignant Neoplasm

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new targeted drug called TSN1611 in people with advanced solid tumors that have a specific genetic mutation called KRAS G12D — a mutation found in many pancreatic, colorectal, and lung cancers that makes tumors grow and resist standard treatments. **You may be eligible if...** - You are between 18 and 75 years old - You have a confirmed advanced or metastatic solid tumor with a KRAS G12D mutation - You have already tried at least one standard treatment that did not work - You are in generally good health (ECOG 0–1) - Your heart, liver, and kidney function are adequate **You may NOT be eligible if...** - You have active brain or spinal cord metastases - You have had recent chemotherapy (within 21 days or 5 half-lives) - You have active lung inflammation or serious lung disease - You had a heart attack, stroke, or serious heart event in the past 6 months - You have previously received KRAS G12D-targeted therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Center

Houston, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

NEXT Virginia

Fairfax, Virginia, 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, China

Shanghai Chest Hospital, Shanghai, China

Shanghai, China

Shanghai Zhongshan Hospital, Shanghai, China

Shanghai, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06385925

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