HSK41959 Added to Standard Treatment for Advanced Lung and Pancreatic Cancers With MTAP Deletion
Tests HSK41959 with standard treatment in adults with MTAP-deleted advanced solid tumors.
Key facts
- Who runs it
- Haisco Pharmaceutical Group Co., Ltd.
- Where
- Shanghai, ChinaSee the site
- Trial code
- Registry title
- HSK41959 With Standard Therapy in Solid Tumors With MTAP Deletion
- Status
- Not yet recruiting
- Phase
- Phase 1
- People taking part
- 258 people, planned
- Started
- Jul 2026
- Expected to end
- Nov 2029
- Type of study
- Interventional, 4 groups
- Treatments tested
- HSK41959
- Sintilimab
- Pemetrexed + Cisplatin /Carboplatin
- Paclitaxel + Carboplatin
- Nab-paclitaxel + Carboplatin
- Nab-paclitaxel + Gemcitabine
- Docetaxel
- Record updated
- 14 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced lung cancer (NSCLC) or pancreatic cancer whose tumour has an MTAP deficiency (MTAP deletion).
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Advanced or metastatic non-small cell lung cancer or pancreatic ductal adenocarcinoma, confirmed by tissue or cell testing, with at least one measurable lesion (RECIST version 1.1).
- Earlier treatment
- Prior treatment must meet the protocol's requirements for each cohort. People who had treatment aimed at the MAT2A or PRMT5 pathway cannot join.
- Biomarker or test result
- Tumour with MTAP deficiency found by a validated test.
Main reasons for not taking part
- Earlier treatment targeting the MAT2A or PRMT5 pathway
- Known driver gene changes excluded for certain lung cancer cohorts (for example EGFR, ALK, ROS1, KRAS G12C)
- Significant stomach or bowel disorders that may affect drug absorption
- Clinically significant heart disease
- Known HIV infection, active hepatitis B or active hepatitis C
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- 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
Where in China
- Shanghai East HospitalShanghai, ChinaNo longer taking part
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Dose-Escalation ArmTreatment being tested
Treatment: HSK41959, Sintilimab, Pemetrexed + Cisplatin /Carboplatin, Paclitaxel + Carboplatin, and Nab-paclitaxel + Carboplatin
- Dose-Expansion：First-line NSCLC cohortTreatment being tested
Treatment: HSK41959, Sintilimab, Pemetrexed + Cisplatin /Carboplatin, Paclitaxel + Carboplatin, and Nab-paclitaxel + Carboplatin
- Dose-Expansion Second-line NSCLC cohortTreatment being tested
Treatment: HSK41959 and Docetaxel
- Dose-Expansion First-line PDAC cohortTreatment being tested
Treatment: HSK41959 and Nab-paclitaxel + Gemcitabine
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- HSK41959 Added to Standard Treatment for Advanced Lung and Pancreatic Cancers With MTAP DeletionGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 14 July 2026