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Study of TSN1611 for Advanced Solid Tumors with KRAS G12D Mutation

This study is testing a new drug called TSN1611 for people with advanced solid tumors that have a specific genetic change called a KRAS G12D mutation. Researchers want to see how safe TSN1611 is and how well it works, both by itself and when combined with other treatments like Cetuximab, Paclitaxel, Gemcitabine, or mFOLFOX6. To join, you must be between 18 and 75 years old, have a life expectancy of at least 3 months, and have a tumor with the KRAS G12D mutation. The study will look at side effects (dose limiting toxicities) and how many patients respond to the treatment (objective response rate) over up to three years. The current status of this study is unclear, and it plans to enroll 440 participants.

Study design
This is a first-in-human, open-label (meaning you and your doctors will know what treatment you are receiving) study with two main parts: a Phase 1 part to find the right dose, and a Phase 2 part to further test effectiveness.
What's involved
You will receive TSN1611 orally, and potentially other medications intravenously, until your disease gets worse or side effects become too much. The study will involve regular check-ups and assessments.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how well the treatment works for up to three years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06385925

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

Recruiting
PHASE1Ages 18–75InterventionalTreatment
Tyligand Pharmaceuticals (Suzhou) Limited
~440 participants
Updated 2026-04-24 on ClinicalTrials.gov
What's tested:TSN1611

At a glance

Recruiting sites
19 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting toxicities (DLTs) in phase 1 part
Measured over 21 days
+1 more outcome measured

Conditions

Malignant Neoplasm

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Colorectal CarcinomaLung Non-Small Cell CarcinomaPancreatic CarcinomaSolid NeoplasmGTPase KRas

Where it's being run

19 sites across 13 states
Zhejiang4
China3
Texas2
Virginia1
Anhui1
Beijing Municipality1
Guangdong1
Hubei1

Study leadership

  • Cindy Li · STUDY_DIRECTOR · Tyligand Bioscience (Shanghai) Limited

Who to contact

Tyligand Clinical Trial Info
[email protected]
+86 021-50720081
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:

Exclusion

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.

What this trial measures

  • Dose limiting toxicities (DLTs) in phase 1 part21 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 partUp to 3 years

    To evaluate the anti-tumor activity of TSN1611 using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.