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Malignant NeoplasmPhase 1/2NCT06385925

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

A Phase 1/2 study testing TSN1611 in people with Malignant Neoplasm, run by Tyligand Pharmaceuticals (Suzhou) Limited at 19 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Malignant Neoplasm
What is being tested?
TSN1611
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
19 sitesin 2 countries
Study dates
29 Apr 2024to 30 Apr 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

19 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Tyligand Clinical Trial Info contact

+86 021-50720081

clinical_trial@tyligand.com

19 sites in 2 countries

China16 sites, 16 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

    Minglei Zhuo

    Minglei Zhuo

    Recruiting

  • Beijing Cancer Hospital, Beijing, China

    Beijing, 100142

    Lin Shen

    Lin Shen, MD

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Lin Wu, MD

    Lin Wu

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

    Ma Ji

    Ji Ma

    Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

    Chengzhi Zhou

    Chengzhi Zhou

    Recruiting

  • Sir Run Run Shaw Hospital - Zhejiang University School of Med

    Hangzhou, Zhejiang

    Haizhou Lou

    Haizhou Lou

    Recruiting

  • The First Affiliated Hospital - Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Jianya Zhou

    Jianya Zhou

    Recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Yuan Ying

    Ying Yuan

    Recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui

    Yueyin Pan

    Yueyin Pan

    Recruiting

  • Linyi Cancer Hospital

    Linyi, Shandong

    Janhua Shi

    Jianhua Shi

    Recruiting

  • The First Affiliated Hospital of Nanchang University - Donghu District

    Nanchang, Jiang

    Yong Li

    Pu Li

    Recruiting

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai Municipality

    Xiaojun Chen

    Xiaojun Chen

    Recruiting

  • Shanghai Chest Hospital, Shanghai, China

    Shanghai, 200030

    Shun Lu

    Shun Lu, MD

    Recruiting

  • Shanghai Zhongshan Hospital, Shanghai, China

    Shanghai, 200032

    Tianshu Liu

    Tianshu Liu, MD

    Recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang

    Dongqing Lv

    Dongqing Lv

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei

    Bin Yang

    Bin Yang

    Recruiting

Other trials in China

United States3 sites, 3 recruiting

  • NEXT Virginia

    Fairfax, Virginia, 22031

    Alexander Spira, MD

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Siqing Fu, MD,PhD

    Recruiting

  • NEXT Oncology

    San Antonio, Texas, 78229

    David Sommerhalder, MD

    Recruiting

Other trials in United States

About this study

Official title: Phase 1/2 Study of TSN1611 in Subjects With Advanced Solid Tumors Harboring KRAS G12D Mutation

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.

Read the detailed description

Phase 1 Part of TSN1611 Monotherapy:

The phase 1 part will evaluate the prespecified dose levels of TSN1611. Dose escalation will continue until up to the highest planned dose or the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is determined. Dose optimization could be performed as indicated by the emerging data.

Phase 2 Part of TSN1611 Monotherapy:

hase 2 part of TSN1611 monotherapy will evaluate the efficacy and safety of TSN1611 as monotherapy at the RP2D until disease progression or unacceptable toxicity in separate groups of patients with pancreatic cancer, colorectal cancer, non-small cell lung cancer, or other solid tumors, harboring KRAS G12D mutations.

Phase 1b/2 Part of TSN1611 Combination Therapy:

This part will consist of the investigations of 3 combined therapies (Cohort A, B and C). In each cohort, there will be a Phase 1b Safety Lead-in Stage to determine the dose of TSN1611 for the combination therapy (this part will be conducted in selected sites), followed by the Phase 2 Expansion Stage to enroll more subjects to determine the efficacy in different cohorts.

Being tested
TSN1611
Keywords
solid tumor, KRAS G12D mutation, pancreatic cancer, colorectal cancer, non-small cell lung cancer, malignant neoplasm
Medical subject headings
Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TSN1611Drug

    TSN1611 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.

  • TSN1611Drug

    TSN1611 BID, Cetuximab will be administered via intravenous infusion at a dose of 500 mg/m² every 2 weeks.

  • TSN1611Drug

    Also called Paclitaxel (albumin-bound)

    TSN1611 BID, Paclitaxel (albumin-bound) at 125 mg/m² and gemcitabine at 1000 mg/m² will be administered via intravenous infusion on Days 1, 8, and 15 of each 4-week cycle.

  • TSN1611Drug

    Also called Oxaliplatin injection, fluorouracil, leucovorin

    TSN1611 BID everyday and Patients will be administered with mFOLFOX6 on Days 1 and 2, every 2 weeks.

Study groups in NCT06385925
Study groupRoleWhat they receive
Phase 1: Dose-finding/evaluation of TSN1611 monotherapyExperimentalThe 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.
Receives: Drug: TSN1611
Phase 2: Dose expansion of TSN1611 monotherapyExperimentalPhase 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.
Receives: Drug: TSN1611
Dose of Phase 1b/2 part of TSN1611 combination therapy-Cohort AExperimentalCohort A: TSN1611 combined with cetuximab treating subjects with advanced solid tumors harboring KRAS G12D mutation:
Receives: Drug: TSN1611
Dose of Phase 1b/2 part of TSN1611 combination therapy-Cohort BExperimentalCohort 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.
Receives: Drug: TSN1611
Dose of Phase 1b/2 part of TSN1611 combination therapy-Cohort CExperimentalCohort 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.
Receives: Drug: TSN1611

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicities (DLTs) in phase 1 part

    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.

    Measured: 21 days

  2. Objective response rate (ORR) in phase 2 part

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

    Measured: Up to 3 years

Secondary outcomes (9)

  1. Adverse events

    To assess the safety profile and tolerability of TSN1611 as monotherapy in subjects with KRAS G12D mutant advanced solid tumors.

    Measured: Up to 3 years

  2. Area under the plasma concentration-time curve (AUC)

    To characterize the pharmacokinetic (PK) profile of TSN1611.

    Measured: 9 weeks

  3. Maximum blood concentrations (Cmax)

    To characterize the PK profile of TSN1611.

    Measured: 9 weeks

  4. Time to maximum blood concentration (Tmax)

    To characterize the PK profile of TSN1611.

    Measured: 9 weeks

  5. Duration of response (DOR)

    To evaluate the anti-tumor activity of TSN1611 using RECIST version 1.1.

    Measured: Up to 3 years

  6. Time to response (TTR)

    To evaluate the anti-tumor activity of TSN1611 using RECIST version 1.1.

    Measured: Up to 3 years

  7. Disease control rate (DCR)

    To evaluate the anti-tumor activity of TSN1611 using RECIST version 1.1.

    Measured: Up to 3 years

  8. Progression free survival (PFS)

    To evaluate the anti-tumor activity of TSN1611 using RECIST version 1.1.

    Measured: Up to 3 years

  9. Overall survival

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2024
  2. Study start29 Apr 2024
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
440 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06385925
Sponsor's protocol ID
TSN1611-2023-101
Status last verified
Apr 2026
First submitted
18 Apr 2024
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TSN1611 in people with Malignant Neoplasm, run by Tyligand Pharmaceuticals (Suzhou) Limited at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tyligand Clinical Trial Info (+86 021-50720081, clinical_trial@tyligand.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicities (DLTs) in phase 1 part (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06385925.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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