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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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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

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.

China1 site

Shanghai East Hospital
Shanghai, Shanghai Municipality

Other trials in China

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

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 groups in NCT07699757
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.

Jul 2026Nov 2029

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)

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

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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