HSK41959 With Standard Therapy in Solid Tumors With MTAP Deletion
- 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.
- Short title
- HSK41959 With Standard Therapy in Solid Tumors With MTAP Deletion
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2029-11-01
- First posted
- 2026-07-13
- Registry last updated
- 2026-07-14
- Primary completion date
- 2029-04-01
- Start date
- 2026-07-01
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07699757
- ClinicalTrials.gov ID
- NCT07699757
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Factorial
- Purpose
- Treatment
- Masking
- No masking
DLTs
Timeframe: 21 days for NSCLC cohorts; 28 days for PDAC cohorts
DLTs assessed during the protocol-defined DLT evaluation period.
AEs
Timeframe: Up to approximately 3 years
Rate and severity of adverse events of HSK41959 Tablets in Combination With Standard Therapy
Overall response rate (ORR)
Timeframe: Up to approximately 3 years
ORR, defined as the proportion of patients who experience a best response of confirmed CR or PR according to RECIST 1.1
Disease control rate (DCR)
Timeframe: Up to approximately 3 years
DCR, defined as the proportion of patients who experience a best response of CR, PR, or stable disease (SD) according to RECIST 1.1
Progression free survival (PFS)
Timeframe: Up to approximately 3 years
PFS, defined as the time frocease or death due to any cause, whichever occurs first
Overall survival (OS)
Timeframe: Up to approximately 3 years
OS, defined as the time from the first dose of HSK41959 until the date of death due to any cause
Area under the curve (AUC) of HSK41959 Tablets in Combination With Standard Therapy
Timeframe: Up to approximately 6 months
maximum plasma concentration (Cmax) of HSK41959 Tablets in Combination With Standard Therapy
Timeframe: Up to approximately 6 months
Tmax(Time to maximum plasma concentration) of HSK41959 Tablets in Combination With Standard Therapy
Timeframe: Up to approximately 6 months
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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.
- Prior exposure to agents targeting the MAT2A or PRMT5 pathway.
- Prior antitumor therapy or unresolved toxicities not meeting protocol-defined washout/recovery requirements.
- 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).
- Significant gastrointestinal disorders that may affect drug absorption.
- Clinically significant cardiovascular disease, including clinically relevant QTc prolongation, reduced left ventricular ejection fraction, or severe heart failure.
- Uncontrolled metabolic disease, uncontrolled hypertension, or active infection.
- Known HIV infection, active hepatitis B with significant viral replication, or active hepatitis C infection.
- 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 serious medical or psychiatric conditions that, in the investigator's judgment, would make study participation inappropriate.
- Shanghai East HospitalShanghai, China
Related records
Drugs (7)
Lead sponsors (1)
Conditions (2)
- Non-small cell lung carcinoma Primary condition
- Pancreatic ductal adenocarcinoma