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RecruitingPhase 1 / Phase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests TSN1611 in people with advanced solid cancers that have a gene change called KRAS G12D. It is the first study of TSN1611 in humans and aims to find suitable doses and see how well it works, alone and with other cancer drugs.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Understand the study and freely sign a consent form.
  • Be at least 18 years old. People in groups B and C must also be 75 or younger.
  • Be expected to live at least 3 months.
  • Be fully active or able to do light work despite some limits on hard physical activity.
  • For phase 1 treatment with TSN1611 alone: have a solid cancer confirmed by tissue or cell testing that has grown nearby or spread and has the KRAS G12D gene change.
  • For phase 1 treatment with TSN1611 alone: standard treatment has not worked, cannot be tolerated, is not available, is not suitable, or is declined.
  • For phase 2 treatment with TSN1611 alone: have confirmed advanced pancreatic duct cancer, colon or rectal cancer, or non-small cell lung cancer with the KRAS G12D gene change. Prior treatment requirements vary by study group.
  • Have heart, liver, kidney, and other organ function that meets study requirements.

Who can't join

  • Have cancer in the lining around the brain or spinal cord, or active cancer spread to the brain or spinal cord.
  • Recently received cancer drugs that act throughout the body or an experimental drug: within 21 days before the first study dose, or a shorter period based on how long the drug stays in the body.
  • Had radiation aimed at curing cancer within 4 weeks, or radiation to ease symptoms within 1 week, before the first study dose.
  • Still have moderate or worse side effects from earlier cancer treatment, except hair loss.
  • Have a history of lung tissue disease or drug-caused lung disease, current lung inflammation, radiation-caused lung inflammation needing treatment, or another uncontrolled lung disease.
  • In the past 6 months, had a heart attack, unstable chest pain, heart failure with symptoms, stroke, mini-stroke, or a blood clot in the lungs.
  • Previously received treatment targeting KRAS G12D.
  • Have a serious condition, other treatment, or abnormal test result that the study doctor believes could affect the results or make participation unsuitable.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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. Exclusion Criteria 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. * 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.

Study sites (3)

TX

VA