HL-085 in NRAS-mutated Advanced Melanoma

• Status: Recruiting
• Trial end date: 2022-11-20
• Target enrollment: 0
• Participant gender: All

Summary

This was an open-label, single-arm, multi-center phase II clinical study, aimed at investigating the efficacy and safety of HL-085 capsule in the treatment of advanced melanoma patients with NRAS mutation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Kechow Pharma, Inc.

Criteria

Inclusion Criteria:

• Aged 18 Years or older (male or female).

• Patients have histologically or cytologically confirmed Unresectable stage III or IV melanoma;

• Able to provide the genetic test report with documented NRAS mutation at baseline.

• At least one target lesion as per RECIST v1.1 criteria.

• Previous chemotherapy, immunotherapy, or radiotherapy must have been completed at least 4 weeks prior to study drug administration, and all related toxic reactions (with the exception of alopecia) must have been resolved (to Grade ≤1 or baseline) prior to study drug administration.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

• Life expectancy > 3 months.

• No major surgery (excluding baseline tumor biopsy) or major trauma occurred at least 14 days prior to study drug administration.

Exclusion Criteria:

• Patients with active central nervous system (CNS) lesions (i.e., radiological evidence of instability, symptomatic lesions) should be excluded. Note: Patients receiving stereotactic brain radiotherapy or surgery who have shown no brain disease progression over a period of 3 months or longer are eligible for inclusion.

• Patients had received any other study treatment within the past 4 weeks prior to study drug administration.

• Inability to swallow the capsule, refractory nausea and vomiting, malabsorption, extracorporeal biliary shunt, or any small intestinal resection that would preclude adequate absorption of the study drug.

• ECG QTcB ≥ 480 msec (adjusted by Bazetts formula) during screening, or a history of congenital long QT syndrome.

• Bleeding symptoms of Grade 3 as defined by the National Cancer Institute General Terminology Standard for Adverse Events (NCI CTCAE V5.0) within the past 4 weeks prior to study initiation.

• One of the following situations occurs within the past 6 months prior to administration of study drug: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass grafting, symptomatic congestive heart failure, serious arrhythmia, uncontrolled hypertension, cerebrovascular accident, or transient ischemic attack, or symptomatic pulmonary embolism.

• Current use of other anti-cancer drugs (hormone therapy was acceptable).

• Uncontrolled concomitant diseases or infectious diseases.

• Patients have retinal vein occlusion (RVO), retinal pigment epithelial detachment (RPED) or other retinal diseases previously or currently.