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Clinical Trials in South Korea / NCT07449754
Recruiting Phase 2

Belvarafenib in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma

NCT07449754 · tracked via the Priya Life Science South Korea tracker
Sponsor
Hanmi Pharmaceutical Company Limited
Phase
Phase 2
Started
2026-02-12
Last updated
2026-03-04

Condition(s) studied

Advanced or Metastatic Melanoma

Investigational drug(s) / intervention(s)

Belvarafenib →Cobimetinib

Belvarafenib: Belvarafenib will be taken twice daily (BID) on Days 1-28 of each cycle

Cobimetinib: Cobimetinib will be taken on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle (three times weekly, TIW), followed by a drug holiday through Day 28

Study summary

This is a Phase 2 open-label, multicenter, single-arm study evaluating the combination of Belvarafenib and Cobimetinib in patients with locally advanced or metastatic melanoma with NRAS mutations. The study plans to assess ORR, DCR, DOR, TTP, PFS, OS and safety of the participating subjects.

Treatment cycles for all subjects will be 28 days in duration and Belvarafenib and Cobimetinib will be administered orally in combination.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * Have histologically, cytologically confirmed locally advanced or metastatic melanoma for which no adequate standard of care exists, or for which standard of care has failed or is not tolerated. * Have NRAS mutation. * Have at least one measurable lesion at baseline per RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * Age of 19 years or older * Adequate renal, hematologic and liver function. Key Exclusion Criteria: * Have a history of prior treatment with RAF, MEK, or ERK inhibitor. * Have past history or ongoing retinal pathology that is considered a risk factor for retinopathy or RVO. * Have past history or ongoing cardiac function-related disorders. * Had hemorrhage or bleeding corresponding to CTCAE Grade ≥3 within 4 weeks prior to the first dose of study drug treatment (Cycle 1 Day 1).

Primary outcome measure(s)

  • Objective response rate (ORR) — Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)
    ORR will be measured as the proportion of subjects with a confirmed response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Independent Central Review (ICR)

Trial sites (10)

FacilityCityRegionStatus
Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Not Yet Recruiting
Chonnam National University Hwasun Hospital Hwasun Jeollanam-do Not Yet Recruiting
Dong-A University Medical Center Busan South Korea Recruiting
Kyungpook National University Chilgok Hospital Daegu South Korea Not Yet Recruiting
Chungnam National University Hospital Daejeon South Korea Not Yet Recruiting
Seoul National University Hospital Seoul South Korea Not Yet Recruiting
Severance Hospital Seoul South Korea Recruiting
Asan Medical Center Seoul South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Korea University Guro Hospital Seoul South Korea Not Yet Recruiting

More Hanmi Pharmaceutical Company Limited trials in South Korea

A Study to Evaluate Efficacy and Safety of HCP1803-4 in Patients With Essential Hypertension Starting soon
A Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin Recruiting
Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects Recruiting
A Study to Evaluate the Pharmacokinetics and Safety Between HIP2503 and HCP1306 in Healthy Volunteers Starting soon
HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07449754 on ClinicalTrials.gov ↗ ← All trials in South Korea