HSK41959 With Standard Therapy in Solid Tumors With MTAP Deletion
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaisco Pharmaceutical Group Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Factorial
Treatments tested in this trial
HSK41959
DrugOral administration, QD
Sintilimab
DrugSpecified dose on specified days
Pemetrexed + Cisplatin /Carboplatin
DrugSpecified dose on specified days
Paclitaxel + Carboplatin
DrugSpecified dose on specified days
Nab-paclitaxel + Carboplatin
DrugSpecified dose on specified days
Nab-paclitaxel + Gemcitabine
DrugSpecified dose on specified days
Docetaxel
DrugSpecified dose on specified days
Treatment groups
258 Participants
are divided into 4 treatment groupsGroup A: Dose-Escalation ArmExperimental treatment 5 interventions
Group B: Dose-Expansion：First-line NSCLC cohortExperimental treatment 5 interventions
Group C: Dose-Expansion Second-line NSCLC cohortExperimental treatment 2 interventions
Group D: Dose-Expansion First-line PDAC cohortExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
DLTs
DLTs assessed during the protocol-defined DLT evaluation period.
Time frame
21 days for NSCLC cohorts; 28 days for PDAC cohorts2
AEs
Rate and severity of adverse events of HSK41959 Tablets in Combination With Standard Therapy
Time frame
Up to approximately 3 yearsSecondary outcomes
1
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
Time frame
Up to approximately 3 years2
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
Time frame
Up to approximately 3 years3
Progression free survival (PFS)
PFS, defined as the time frocease or death due to any cause, whichever occurs first
Time frame
Up to approximately 3 years4
Overall survival (OS)
OS, defined as the time from the first dose of HSK41959 until the date of death due to any cause
Time frame
Up to approximately 3 yearsSponsors and contacts
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Source ClinicalTrials.gov
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