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

Part of paid clinical trials in Houston, Texas.

Sponsor
Tyligand Pharmaceuticals (Suzhou) Limited
Study ID
NCT06385925
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Malignant Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • TSN1611 — DRUG
    TSN1611 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.
  • TSN1611 — DRUG
    TSN1611 BID, Cetuximab will be administered via intravenous infusion at a dose of 500 mg/m² every 2 weeks.
  • TSN1611 — DRUG
    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.
  • TSN1611 — DRUG
    TSN1611 BID everyday and Patients will be administered with mFOLFOX6 on Days 1 and 2, every 2 weeks.

Study Details

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.

Key Dates

Start date
Apr 29, 2024
Status verified
Apr 2026
Primary completion
Oct 30, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
440 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: Dose-finding/evaluation of TSN1611 monotherapy
    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.
  • Experimental: Phase 2: Dose expansion of TSN1611 monotherapy
    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.
  • Experimental: Dose of Phase 1b/2 part of TSN1611 combination therapy-Cohort A
    Cohort A: TSN1611 combined with cetuximab treating subjects with advanced solid tumors harboring KRAS G12D mutation:
  • Experimental: Dose of Phase 1b/2 part of TSN1611 combination therapy-Cohort B
    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.
  • Experimental: Dose of Phase 1b/2 part of TSN1611 combination therapy-Cohort C
    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.

Primary Outcome Measure

Dose limiting toxicities (DLTs) in phase 1 part [ Time Frame: 21 days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Siqing Fu, MD,PhD
NEXT OncologySan AntonioTexas78229
David Sommerhalder, MD
NEXT VirginiaFairfaxVirginia22031
Alexander Spira, MD

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