HSK41959 With Standard Therapy in Solid Tumors With MTAP Deletion
NCT07699757 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 258
Last updated 2026-07-14
Summary
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.
Conditions
- Non-Small Cell Lung Cancer
- Pancreatic Ductal Adenocarcinoma (mPDAC)
- Advanced Solid Tumors
Interventions
- DRUG
-
HSK41959
Oral administration, QD
- DRUG
-
Sintilimab
Specified dose on specified days
- DRUG
-
Pemetrexed + Cisplatin /Carboplatin
Specified dose on specified days
- DRUG
-
Paclitaxel + Carboplatin
Specified dose on specified days
- DRUG
-
Nab-paclitaxel + Carboplatin
Specified dose on specified days
- DRUG
-
Nab-paclitaxel + Gemcitabine
Specified dose on specified days
- DRUG
-
Specified dose on specified days
Sponsors & Collaborators
-
Haisco Pharmaceutical Group Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2029-04-30
- Completion
- 2029-11-30
Countries
- China
Study Locations
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