HSK41959 With Standard Therapy in Solid Tumors With MTAP Deletion

July 12, 2026 updated by: Haisco Pharmaceutical Group Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
258

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Shanghai East Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult participants aged 18 years or older.
  2. ECOG performance status of 0 to 1.
  3. Life expectancy of at least 3 months.
  4. Histologically or cytologically confirmed advanced malignant tumor with MTAP deficiency identified by a validated assay.
  5. At least one measurable lesion according to RECIST version 1.1.
  6. For NSCLC cohorts: advanced or metastatic NSCLC meeting protocol-specified disease characteristics and prior treatment requirements.
  7. For PDAC cohorts: advanced or metastatic PDAC meeting protocol-specified disease characteristics and prior treatment requirements.
  8. Adequate bone marrow, hepatic, renal, and coagulation function.
  9. Willingness to provide tumor tissue and/or undergo protocol-required biomarker testing, if applicable.

Exclusion Criteria:

  1. Prior exposure to agents targeting the MAT2A or PRMT5 pathway.
  2. Prior antitumor therapy or unresolved toxicities not meeting protocol-defined washout/recovery requirements.
  3. 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).
  4. Significant gastrointestinal disorders that may affect drug absorption.
  5. Clinically significant cardiovascular disease, including clinically relevant QTc prolongation, reduced left ventricular ejection fraction, or severe heart failure.
  6. Uncontrolled metabolic disease, uncontrolled hypertension, or active infection.
  7. Known HIV infection, active hepatitis B with significant viral replication, or active hepatitis C infection.
  8. 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.
  9. Other serious medical or psychiatric conditions that, in the investigator's judgment, would make study participation inappropriate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose-Escalation Arm
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
Experimental: Dose-Expansion：First-line NSCLC cohort
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
Experimental: Dose-Expansion Second-line NSCLC cohort
Drug: Docetaxel
Specified dose on specified days
Drug: HSK41959
Oral administration, QD
Experimental: Dose-Expansion First-line PDAC cohort
Drug: HSK41959
Oral administration, QD
Drug: Nab-paclitaxel + Gemcitabine
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
DLTs
Time Frame: 21 days for NSCLC cohorts; 28 days for PDAC cohorts
DLTs assessed during the protocol-defined DLT evaluation period.
21 days for NSCLC cohorts; 28 days for PDAC cohorts
AEs
Time Frame: Up to approximately 3 years
Rate and severity of adverse events of HSK41959 Tablets in Combination With Standard Therapy
Up to approximately 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: 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
Up to approximately 3 years
Disease control rate (DCR)
Time Frame: 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
Up to approximately 3 years
Progression free survival (PFS)
Time Frame: Up to approximately 3 years
PFS, defined as the time frocease or death due to any cause, whichever occurs first
Up to approximately 3 years
Overall survival (OS)
Time Frame: 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
Up to approximately 3 years
Area under the curve (AUC) of HSK41959 Tablets in Combination With Standard Therapy
Time Frame: Up to approximately 6 months
Up to approximately 6 months
maximum plasma concentration (Cmax) of HSK41959 Tablets in Combination With Standard Therapy
Time Frame: Up to approximately 6 months
Up to approximately 6 months
Tmax(Time to maximum plasma concentration) of HSK41959 Tablets in Combination With Standard Therapy
Time Frame: Up to approximately 6 months
Up to approximately 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Haisco Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSK41959-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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