Phase I Study of Oral HSK42360-Na for Patients With Locally Advanced or Metastatic Solid Tumors Having BRAF V600 Mutation

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics PK, and pharmacodynamics PD of HSK42360-Na, an oral drug, in patients with locally advanced or metastatic solid tumors that have a BRAF V600 mutation. This phase I, open-label study includes patients who have active tumors and may have previously received BRAF andor MEK inhibitor therapy. The study is sponsored by Haisco Pharmaceutical Group Co., Ltd. and aims to understand how the drug behaves in the body and its safety profile. The study has two parts Phase 1a involves dose escalation of HSK42360-Na as monotherapy at various dose levels to find the maximum tolerated dose. Phase 1b is a dose expansion phase where patients receive HSK42360-Na at the dose determined in Phase 1a. Treatment is given orally. The study does not use randomization or blinding. Participants will be monitored for up to approximately 52 months for safety outcomes including dose-limiting toxicities, adverse events, and performance status evaluations. Researchers will also assess tumor response rates, disease control, duration of response, progression-free survival, and overall survival. Pharmacokinetic parameters such as maximum plasma concentration and half-life of HSK42360-Na will be measured during single-dose and multiple-dose periods. Participants may provide blood or tumor samples and will be followed closely throughout the study period.

Phase I Study of HSK42360-Na in Solid Tumors With BRAF V600 Mutation