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
Qualifiers
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
Treatments tested in this trial
- HSK41959
- Sintilimab
- Pemetrexed + Cisplatin /Carboplatin
- Paclitaxel + Carboplatin
- Nab-paclitaxel + Carboplatin
- Nab-paclitaxel + Gemcitabine
- Docetaxel
Treatment groups
258 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov