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

Recruiting now · Phase 1/Phase 2

Conditions studied: Malignant Neoplasm

In brief

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.

Key facts

Study ID

NCT06385925

Run by

Tyligand Pharmaceuticals (Suzhou) Limited

People needed

440

Starts

2024-04-29

Expected to finish

2027-04-30

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects will be excluded if they meet any of the following criteria:
• Leptomeningeal disease or Active central nervous system (CNS) metastases.
• Prior systemic anti-cancer treatment within 21 days or 5 half-lives (whichever is shorter will be used as the criteria) prior to the first dose of study drug.
• Radical radiation within 4 weeks prior to the first dose of study drug; palliative radiotherapy within 1 week prior to the first dose of study drug.
• Any unresolved Grade 2 or higher toxicity from previous anticancer therapy except alopecia.
• Has participated in a study of investigational agent and received the investigational agent within 21 days or 5 half-lives, if known (whichever is shorter) prior to the first dose of study drug.
• History of interstitial lung disease (ILD), drug induced IDL, or current active pneumonitis, radiation pneumonitis requiring therapeutic intervention, or uncontrolled other lung disease.
• Any of the following in the past 6 months: myocardial infarction, unstable angina, symptomatic congestive heart failure, stroke or transient ischemic attack, pulmonary embolism.
• Prior treatment with KRAS G12D targeted therapy.
• Has a history or current evidence of any severe condition, concurrent therapy, or laboratory abnormality that might confound the interpretation of the study results, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the investigator.

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• NEXT Oncology — San Antonio, Texas, United States (enrolling)
• NEXT Virginia — Fairfax, Virginia, United States (enrolling)
• Anhui Provincial Cancer Hospital — Hefei, Anhui, China (enrolling)
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (enrolling)
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (enrolling)
• Hubei Cancer Hospital — Wuhan, Hubei, China (enrolling)
• Hunan Cancer Hospital — Changsha, Hunan, China (enrolling)
• The First Affiliated Hospital of Nanchang University - Donghu District — Nanchang, Jiang, China (enrolling)
• Linyi Cancer Hospital — Linyi, Shandong, China (enrolling)
• Shanghai Tenth People's Hospital — Shanghai, Shanghai Municipality, China (enrolling)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (enrolling)
• Sir Run Run Shaw Hospital - Zhejiang University School of Med — Hangzhou, Zhejiang, China (enrolling)
• The First Affiliated Hospital - Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
• Taizhou Hospital of Zhejiang Province — Taizhou, Zhejiang, China (enrolling)
• Beijing Cancer Hospital, Beijing, China — Beijing, China (enrolling)
• Shanghai Chest Hospital, Shanghai, China — Shanghai, China (enrolling)
• Shanghai Zhongshan Hospital, Shanghai, China — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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