Non-Small Cell Lung CancerPhase 1NCT07699757
HSK41959 With Standard Therapy in Solid Tumors With MTAP Deletion
A Phase 1 study testing HSK41959, Sintilimab and Pemetrexed + Cisplatin /Carboplatin in people with Non-Small Cell Lung Cancer and Pancreatic Ductal Adenocarcinoma (mPDAC), run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma (mPDAC), Advanced Solid Tumors
- What is being tested?
- HSK41959, Sintilimab and Pemetrexed + Cisplatin /Carboplatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to Nov 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- HSK41959, Sintilimab, Pemetrexed + Cisplatin /Carboplatin, Paclitaxel + Carboplatin, Nab-paclitaxel + Carboplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK41959Drug
Oral administration, QD
SintilimabDrug
Specified dose on specified days
Pemetrexed + Cisplatin /CarboplatinDrug
Specified dose on specified days
Paclitaxel + CarboplatinDrug
Specified dose on specified days
Nab-paclitaxel + CarboplatinDrug
Specified dose on specified days
Nab-paclitaxel + GemcitabineDrug
Specified dose on specified days
DocetaxelDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Dose-Escalation Arm | Experimental | Not described Receives: Drug: HSK41959; Drug: Sintilimab; Drug: Pemetrexed + Cisplatin /Carboplatin; Drug: Paclitaxel + Carboplatin; Drug: Nab-paclitaxel + Carboplatin |
| Dose-Expansion：First-line NSCLC cohort | Experimental | Not described Receives: Drug: HSK41959; Drug: Sintilimab; Drug: Pemetrexed + Cisplatin /Carboplatin; Drug: Paclitaxel + Carboplatin; Drug: Nab-paclitaxel + Carboplatin |
| Dose-Expansion Second-line NSCLC cohort | Experimental | Not described Receives: Drug: HSK41959; Drug: Docetaxel |
| Dose-Expansion First-line PDAC cohort | Experimental | Not described Receives: Drug: HSK41959; Drug: Nab-paclitaxel + Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLTs
DLTs assessed during the protocol-defined DLT evaluation period.
Measured: 21 days for NSCLC cohorts; 28 days for PDAC cohorts
AEs
Rate and severity of adverse events of HSK41959 Tablets in Combination With Standard Therapy
Measured: Up to approximately 3 years
Secondary outcomes (7)
Overall response rate (ORR)
ORR, defined as the proportion of patients who experience a best response of confirmed CR or PR according to RECIST 1.1
Measured: Up to approximately 3 years
Disease control rate (DCR)
DCR, defined as the proportion of patients who experience a best response of CR, PR, or stable disease (SD) according to RECIST 1.1
Measured: Up to approximately 3 years
Progression free survival (PFS)
PFS, defined as the time frocease or death due to any cause, whichever occurs first
Measured: Up to approximately 3 years
Overall survival (OS)
OS, defined as the time from the first dose of HSK41959 until the date of death due to any cause
Measured: Up to approximately 3 years
Area under the curve (AUC) of HSK41959 Tablets in Combination With Standard Therapy
Measured: Up to approximately 6 months
maximum plasma concentration (Cmax) of HSK41959 Tablets in Combination With Standard Therapy
Measured: Up to approximately 6 months
Tmax(Time to maximum plasma concentration) of HSK41959 Tablets in Combination With Standard Therapy
Measured: Up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699757
- Sponsor's protocol ID
- HSK41959-102
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07699757
- Acronym / sponsor ID
- HSK41959-102
- Conditions
- Non-Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma (mPDAC), Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose-Escalation Arm | Experimental | Drug: HSK41959, Drug: Sintilimab, Drug: Pemetrexed + Cisplatin /Carboplatin, Drug: Paclitaxel + Carboplatin, Drug: Nab-paclitaxel + Carboplatin |
| Dose-Expansion：First-line NSCLC cohort | Experimental | Drug: HSK41959, Drug: Sintilimab, Drug: Pemetrexed + Cisplatin /Carboplatin, Drug: Paclitaxel + Carboplatin, Drug: Nab-paclitaxel + Carboplatin |
| Dose-Expansion Second-line NSCLC cohort | Experimental | Drug: HSK41959, Drug: Docetaxel |
| Dose-Expansion First-line PDAC cohort | Experimental | Drug: HSK41959, Drug: Nab-paclitaxel + Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK41959Oral administration, QD | Drug | Dose-Escalation Arm, Dose-Expansion First-line PDAC cohort, Dose-Expansion Second-line NSCLC cohort, Dose-Expansion：First-line NSCLC cohort |
| SintilimabSpecified dose on specified days | Drug | Dose-Escalation Arm, Dose-Expansion：First-line NSCLC cohort |
| Pemetrexed + Cisplatin /CarboplatinSpecified dose on specified days | Drug | Dose-Escalation Arm, Dose-Expansion：First-line NSCLC cohort |
| Paclitaxel + CarboplatinSpecified dose on specified days | Drug | Dose-Escalation Arm, Dose-Expansion：First-line NSCLC cohort |
| Nab-paclitaxel + CarboplatinSpecified dose on specified days | Drug | Dose-Escalation Arm, Dose-Expansion：First-line NSCLC cohort |
| Nab-paclitaxel + GemcitabineSpecified dose on specified days | Drug | Dose-Expansion First-line PDAC cohort |
| DocetaxelSpecified dose on specified days | Drug | Dose-Expansion Second-line NSCLC cohort |
Primary outcome
DLTs
Time frame: 21 days for NSCLC cohorts; 28 days for PDAC cohorts
DLTs assessed during the protocol-defined DLT evaluation period.
AEs
Time frame: Up to approximately 3 years
Rate and severity of adverse events of HSK41959 Tablets in Combination With Standard Therapy
7 secondary outcomes
Overall response rate (ORR)
Time frame: Up to approximately 3 years
Disease control rate (DCR)
Time frame: Up to approximately 3 years
Progression free survival (PFS)
Time frame: Up to approximately 3 years
Overall survival (OS)
Time frame: 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
maximum plasma concentration (Cmax) of HSK41959 Tablets in Combination With Standard Therapy
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HSK41959, Sintilimab and Pemetrexed + Cisplatin /Carboplatin in people with Non-Small Cell Lung Cancer and Pancreatic Ductal Adenocarcinoma (mPDAC), run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLTs (time frame: 21 days for NSCLC cohorts; 28 days for PDAC cohorts). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.