HSK41959 With Standard Therapy in Solid Tumors With MTAP Deletion

Sponsor
Haisco Pharmaceutical Group Co., Ltd.
Study ID
NCT07699757
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

  • HSK41959 — DRUG
    Oral administration, QD
  • Sintilimab — DRUG
    Specified dose on specified days
  • Pemetrexed + Cisplatin /Carboplatin — DRUG
    Specified dose on specified days
  • Paclitaxel + Carboplatin — DRUG
    Specified dose on specified days
  • Nab-paclitaxel + Carboplatin — DRUG
    Specified dose on specified days
  • Nab-paclitaxel + Gemcitabine — DRUG
    Specified dose on specified days
  • Docetaxel — DRUG
    Specified dose on specified days

Study Details

This is a Phase Ib, open-label, multicenter study of HSK41959 tablets in combination with standard therapy in patients with MTAP-deficient advanced solid tumors. The study consists of dose-escalation and dose-expansion parts and is intended to evaluate the safety, tolerability, dose-limiting toxicity, maximum tolerated dose, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HSK41959 tablets when used together with standard therapy.

Key Dates

First listed
Jul 13, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Apr 30, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
258 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose-Escalation Arm
  • Experimental: Dose-Expansion：First-line NSCLC cohort
  • Experimental: Dose-Expansion Second-line NSCLC cohort
  • Experimental: Dose-Expansion First-line PDAC cohort

Primary Outcome Measure

DLTs [ Time Frame: 21 days for NSCLC cohorts; 28 days for PDAC cohorts ]

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