Phase I Study of HSK42360-Na in Solid Tumors With BRAF V600 Mutation
ConditionSolid Tumors (Phase 1)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaisco Pharmaceutical Group Co., Ltd.
About this trial
This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK42360-Na when given orally in patients with active BRAF V600 mutation locally advanced or metastatic Solid Tumors.
Eligibility criteria
Qualifiers
Age ≥ 18 years#Male and female patients, at time of signing informed consent form (ICF).
ECOG performance status 0-1, or KPS (Karnofsky Performance Status) Score≥70.
Life expectancy ≥ 3 months.
Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology, who have failed standard treatment (disease progression after treatment or intolerable treatment); patients who have previously received BRAF and/or MEK inhibitor therapy are allowed to be included in this study.
Disqualifiers
malignant tumor within 2 years, with the exception of cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, or other tumors with low malignancy.
Uncontrollable pleural effusion, ascites, or pericardial effusion per protocol.
Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the exception of alopecia, dermal toxicity, and other toxicity considering no safety risks by investigator.
Any disease which would preclude drug absorption, metabolism or pharmacokinetics, e.g. active peptic ulcer or chronic gastroesophageal reflux disease.
Trial design
Treatments tested in this trial
- HSK42360-Na
Treatment groups
159 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov