A Phase Ib Study of HS-10370 in Addition to Other Anti-cancer Therapies in Patients With Advanced Solid Tumors

Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study ID
NCT06963502
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HS-10370 — DRUG
    Participants will receive HS-10370 dose 1 administered orally
  • HS-20117 — DRUG
    Participants will receive HS-20117 given as dose 3 intravenous infusion(IV) once every 14-day cycle.
  • Adebrelimab — DRUG
    Participants will receive Adebrelimab intravenous infusion(IV) once every 21-day cycle
  • Capecitabine — DRUG
    Participants will receive Capecitabine administered orally
  • Oxaliplatin — DRUG
    Participants will receive Oxaliplatin intravenous infusion(IV) once every 21-day cycle.
  • Folinic Acid, Fluorouracil and Oxaliplatin/Irinotecan — DRUG
    Participants will receive Folinic Acid, Fluorouracil and Oxaliplatin/Irinotecan intravenous infusion(IV) once every 14-day cycle.
  • HS-20093 — DRUG
    Participants will receive HS-20093 intravenous infusion(IV) once every 21-day cycle
  • platinum (cisplatin or carboplatin) — DRUG
    Participants will receive platinum (cisplatin or carboplatin) administered IV in 21-day cycles.

Study Details

This is a Phase Ib study that will evaluate the Safety, Tolerability , Pharmacokinetics, Activity and Immunogenicity of HS-10370 in Combination With Other Anti-cancer Therapies in Chinese patients with KRAS G12C mutation advanced or metastatic solid tumors, especially in and Colorectal cancer(CRC) and non-Small cell lung cancer (NSCLC).

Key Dates

Start date
May 30, 2025
Status verified
Apr 2025
Primary completion
Dec 31, 2028
Completion
Apr 30, 2030

Study Design

Enrollment
762 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1:HS-10370 dose 1+ HS-20117 dose 3
  • Experimental: Arm 2: HS-10370 dose 2 +HS-20117 dose 4+ Adebrelimab
  • Experimental: Arm 3: HS-10370 dose 1 + HS-20117 dose4 + Chemotherapy
  • Experimental: Arm 4: HS-10370 dose 1 + HS-20117 dose3 + Chemotherapy
  • Experimental: Arm 5:HS-10370 dose1+ HS-20117 dose 4+HS-20093 dose 5
  • Experimental: Arm 6:HS-10370 dose 2 +HS-20093 dose 5+ Adebrelimab
  • Experimental: Arm 7:HS-10370 dose 2 +HS-20093 dose 6+ Adebrelimab+ Chemotherapy

Primary Outcome Measure

Number of Participants with Adverse Event(s) (AEs) [ Time Frame: From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days). ]

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