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Taking people in ChinaPhase 1/2

Tests TSN1611 in adults with advanced solid tumors carrying KRAS G12D mutation

Tests TSN1611 in adults with advanced solid tumors having a KRAS G12D change.

Key facts

Who runs it
Tyligand Pharmaceuticals (Suzhou) Limited
Where
Beijing, Changsha, Chengdu, Guangzhou, Hangzhou, Hefei, Linyi, Nanchang, Shanghai, Taizhou, and Wuhan, ChinaSee the 16 sitesAlso in 1 other country, 3 sites
Trial code
Registry title
A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
Status
Recruiting
Phase
Phase 1/2
People taking part
440 people, planned
Started
29 Apr 2024
Expected to end
30 Apr 2027
Type of study
Interventional, 5 groups
Treatments tested
  • TSN1611
Record updated
24 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with an advanced solid tumor that carries a KRAS G12D mutation. Phase 1 needs people who did not respond to standard treatment or have none available.

Age
At least 18 years. Up to 75 years for Cohort B and C.
Sex
All sexes can join.
Disease stage
Locally advanced or metastatic solid tumor, confirmed by tissue or cell tests. Phase 2 looks at pancreatic cancer (PDAC), colorectal cancer (CRC) and lung cancer (NSCLC). Good daily function (ECOG 0 or 1) and life expectancy of 3 months or more.
Earlier treatment
Phase 1: standard treatment did not work or was not tolerated, none is available, or the person is not able to have it or declines it. Phase 2: the number of earlier treatments depends on the cohort.
Biomarker or test result
KRAS G12D mutation in the tumor.

Main reasons for not taking part

  • Cancer spread to the lining of the brain or active brain metastases
  • Earlier treatment with a KRAS G12D targeted therapy
  • Systemic anti-cancer treatment or another study drug within 21 days or 5 half-lives before the first dose
  • Interstitial lung disease or active pneumonitis
  • Heart attack, unstable angina, heart failure, stroke or pulmonary embolism in the past 6 months

The registry criteria, word for word

Show all 17 criteriaShow less

Who cannot take part

  • 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
  • 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
  • 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
  • Subjects will be excluded if they meet any of the following criteria:

Other criteria

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in China

Also in 1 other country, 3 sites

  • Beijing Cancer HospitalBeijing, ChinaContact: Minglei ZhuoTaking people
  • Beijing Cancer Hospital, Beijing, ChinaBeijing, ChinaContact: Lin ShenTaking people
  • Hunan Cancer HospitalChangsha, ChinaContact: Lin Wu, MDTaking people
  • West China Hospital，Sichuan UniversityChengdu, ChinaContact: Ma JiTaking people
  • The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaContact: Chengzhi ZhouTaking people
  • Sir Run Run Shaw Hospital - Zhejiang University School of MedHangzhou, ChinaContact: Haizhou LouTaking people
  • The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaContact: Jianya ZhouTaking people
  • The Second Affiliated Hospital of Zhejiang University School of MedicineHangzhou, ChinaContact: Yuan YingTaking people
  • Anhui Provincial Cancer HospitalHefei, ChinaContact: Yueyin PanTaking people
  • LinYi Cancer HospitalLinyi, ChinaContact: Janhua ShiTaking people
  • The First Affiliated Hospital of Nanchang University - Donghu DistrictNanchang, ChinaContact: Yong LiTaking people
  • Shanghai Chest Hospital, Shanghai, ChinaShanghai, ChinaContact: Shun LuTaking people
  • Shanghai Tenth People's HospitalShanghai, ChinaContact: Xiaojun ChenTaking people
  • Shanghai Zhongshan Hospital, Shanghai, ChinaShanghai, ChinaContact: Tianshu LiuTaking people
  • Taizhou Hospital of Zhejiang ProvinceTaizhou, ChinaContact: Dongqing LvTaking people
  • Hubei Cancer HospitalWuhan, ChinaContact: Bin YangTaking people

About the trial

What the trial wants to find out

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.

The 5 groups in the trial

  • Phase 1: Dose-finding/evaluation of TSN1611 monotherapyTreatment being tested

    The phase 1 part will evaluate the prespecified sequential dose levels of TSN1611 in subjects with KRAS G12D mutant advanced solid tumors to determine the recommended dose of TSN1611 for further investigation.

    Treatment: TSN1611

  • Phase 2: Dose expansion of TSN1611 monotherapyTreatment being tested

    Phase 2 part will evaluate the efficacy and safety of TSN1611 as monotherapy at the recommended dose level in separate groups of patients with pancreatic cancer, colorectal cancer, non-small cell lung cancer, or other solid tumors, harboring KRAS G12D mutations.

    Treatment: TSN1611

  • Dose of Phase 1b/2 part of TSN1611 combination therapy-Cohort ATreatment being tested

    Cohort A: TSN1611 combined with cetuximab treating subjects with advanced solid tumors harboring KRAS G12D mutation:

    Treatment: TSN1611

  • Dose of Phase 1b/2 part of TSN1611 combination therapy-Cohort BTreatment being tested

    Cohort B: TSN1611 combined with GnP regimen (i.e., gemcitabine and nab-paclitaxel) treating subjects with advanced PDAC with KRAS G12D mutation who received no prior systemic treatment in the advanced setting.

    Treatment: TSN1611

  • Dose of Phase 1b/2 part of TSN1611 combination therapy-Cohort CTreatment being tested

    Cohort C: TSN1611 combined with cetuximab and mFOLFOX6 regimen (i.e., fluorouracil, leucovorin, oxaliplatin) treating subjects with advanced CRC with KRAS G12D mutation who received no prior systemic treatment in the advanced setting.

    Treatment: TSN1611

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Phase 1/2 Study of TSN1611 in Subjects With Advanced Solid Tumors Harboring KRAS G12D Mutation
Plain-language title
Tests TSN1611 in adults with advanced solid tumors carrying KRAS G12D mutationGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06385925, who can take part
Record updated
24 April 2026