Actively Recruiting
A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
Led by Tyligand Pharmaceuticals (Suzhou) Limited · Updated on 2026-04-24
440
Participants Needed
19
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject fully understands the study and voluntarily signs informed consent.
- Age 18 years or older; up to 75 years for certain cohorts.
- Life expectancy of at least 3 months.
- ECOG performance status of 0 or 1.
- Histologically or cytologically confirmed advanced or metastatic solid tumor with KRAS G12D mutation.
- Refractory or intolerant to standard treatment, no standard treatment available, or ineligible/declines standard treatment.
- For phase 2 monotherapy: pancreatic, colorectal, or non-small cell lung cancer with KRAS G12D mutation.
- Adequate heart, liver, and kidney function.
You will not qualify if you...
- Presence of leptomeningeal disease or active central nervous system metastases.
- Received systemic anti-cancer treatment within 21 days or 5 half-lives prior to first study dose.
- Received radical radiation within 4 weeks or palliative radiation within 1 week prior to first study dose.
- Unresolved Grade 2 or higher toxicity from prior therapy except alopecia.
- Participated in investigational drug study and received study drug within 21 days or 5 half-lives before first dose.
- History or current interstitial lung disease, drug-induced ILD, active pneumonitis, radiation pneumonitis needing treatment, or uncontrolled lung disease.
- Experienced myocardial infarction, unstable angina, symptomatic heart failure, stroke, transient ischemic attack, or pulmonary embolism in past 6 months.
- Prior treatment targeting KRAS G12D mutation.
- Any severe condition or lab abnormality that may interfere with study participation or interpretation of results as judged by investigator.
AI-Screening
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Trial Site Locations
Total: 19 locations
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
2
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
3
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
4
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Actively Recruiting
5
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
6
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Actively Recruiting
7
Hubei Cancer Hospital
Wuhan, Hubei, China
Actively Recruiting
8
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
9
The First Affiliated Hospital of Nanchang University - Donghu District
Nanchang, Jiang, China
Actively Recruiting
10
Linyi Cancer Hospital
Linyi, Shandong, China
Actively Recruiting
11
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
12
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
13
Sir Run Run Shaw Hospital - Zhejiang University School of Med
Hangzhou, Zhejiang, China
Actively Recruiting
14
The First Affiliated Hospital - Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
15
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
16
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Actively Recruiting
17
Beijing Cancer Hospital, Beijing, China
Beijing, China, 100142
Actively Recruiting
18
Shanghai Chest Hospital, Shanghai, China
Shanghai, China, 200030
Actively Recruiting
19
Shanghai Zhongshan Hospital, Shanghai, China
Shanghai, China, 200032
Actively Recruiting
Research Team
T
Tyligand Clinical Trial Info
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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