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Not yet recruiting NCT07699757

HSK41959 With Standard Therapy in Solid Tumors With MTAP Deletion

Phase I Interventional Non-Small Cell Lung Cancer Pancreatic Ductal Adenocarcinoma (mPDAC) Advanced Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HSK41959, Sintilimab, Pemetrexed + Cisplatin /Carboplatin, Paclitaxel + Carboplatin.
Who it may be relevant to
Registry conditions: Non-Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma (mPDAC), Advanced Solid Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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
  • Drug Nab-paclitaxel + Gemcitabine
    Specified dose on specified days
  • Drug Docetaxel
    Specified dose on specified days

Primary outcome measures

  • DLTs [Time frame: 21 days for NSCLC cohorts; 28 days for PDAC cohorts]
  • AEs [Time frame: Up to approximately 3 years]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Factorial
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai East Hospital — Shanghai

Identifiers

NCT: NCT07699757 · HSK41959-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗