NCT06385925RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 440 (estimated)
- First submitted
- 18 Apr 2024
- Start date
- 29 Apr 2024
- Primary completion date
- 30 Oct 2026
- Lead sponsor
- Tyligand Pharmaceuticals (Suzhou) Limited
- Diseases
- Lung cancer, Pancreatic cancer, Colorectal cancer
- NCT number
- NCT06385925
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 440
- From 29 Apr 2024 to the primary completion date, 30 Oct 2026
- 19 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Prior treatment with KRAS G12D targeted therapy.
Other illness
- Leptomeningeal disease or Active central nervous system (CNS) metastases.
- 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.
Lab values
- 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.
Other
- Subjects will be excluded if they meet any of the following criteria:
Criteria the registry did not label
- Subjects must meet all the following inclusion criteria to be eligible for participation in this study:
- 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:
- Subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumor harboring KRAS G12D mutation; subjects must be refractory or intolerable to standard treatment, or have no standard treatment available, or the subject is ineligible or declines standard treatment.
- Phase 2 part of TSN1611 Monotherapy:
- Subjects with histologically or cytologically confirmed locally advanced or metastatic PDAC、CRC and NSCLC harboring KRAS G12D mutation; According to the requirements of different combined cohorts, the number of previous treatments is taken into account.
- Patients with adequate cardiac, liver, renal function, etc.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital, Beijing, China Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| West China Hospital，Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Sir Run Run Shaw Hospital - Zhejiang University School of Med Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The Second Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Anhui Provincial Cancer Hospital Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| LinYi Cancer Hospital Coordinator of this site? Confirm its status | Linyi | China | Recruiting |
| The First Affiliated Hospital of Nanchang University - Donghu District Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Shanghai Zhongshan Hospital, Shanghai, China Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai Chest Hospital, Shanghai, China Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai Tenth People's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Taizhou Hospital of Zhejiang Province Coordinator of this site? Confirm its status | Taizhou | China | Recruiting |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| NEXT Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| NEXT Oncology Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.