NCT07699757Not yet recruitingPhase 1
HSK41959 With Standard Therapy in Solid Tumors With MTAP Deletion
Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HSK41959 Tablets in Combination With Standard Therapy in Patients With MTAP Deletion Locally Advanced or Metastatic Solid Tumors
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 258 (estimated)
- First submitted
- 26 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 30 Apr 2029
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Diseases
- Lung cancer, Pancreatic cancer
- NCT number
- NCT07699757
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 258
- From 1 Jul 2026 to the primary completion date, 30 Apr 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior exposure to agents targeting the MAT2A or PRMT5 pathway.
- Prior antitumor therapy or unresolved toxicities not meeting protocol-defined washout/recovery requirements.
- Use of prohibited concomitant medications, including strong inhibitors or inducers of CYP3A4, P-gp, BCRP, or other protocol-specified transporters/enzymes within the required washout period.
Other illness
- Significant gastrointestinal disorders that may affect drug absorption.
- Uncontrolled metabolic disease, uncontrolled hypertension, or active infection.
- Known HIV infection, active hepatitis B with significant viral replication, or active hepatitis C infection.
- Other serious medical or psychiatric conditions that, in the investigator's judgment, would make study participation inappropriate.
Lab values
- Known actionable driver alterations or prior therapies excluded by the protocol for specific NSCLC cohorts (for example EGFR, ALK, ROS1, BRAF, NTRK, MET, RET, KRAS G12C, HER2, as applicable).
- Clinically significant cardiovascular disease, including clinically relevant QTc prolongation, reduced left ventricular ejection fraction, or severe heart failure.
Who the study is looking for
- Adult participants aged 18 years or older.
- ECOG performance status of 0 to 1.
- Life expectancy of at least 3 months.
- Histologically or cytologically confirmed advanced malignant tumor with MTAP deficiency identified by a validated assay.
- At least one measurable lesion according to RECIST version 1.1.
- For NSCLC cohorts: advanced or metastatic NSCLC meeting protocol-specified disease characteristics and prior treatment requirements.
- For PDAC cohorts: advanced or metastatic PDAC meeting protocol-specified disease characteristics and prior treatment requirements.
- Adequate bone marrow, hepatic, renal, and coagulation function.
- Willingness to provide tumor tissue and/or undergo protocol-required biomarker testing, if applicable.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai East Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.