RecruitingPhase 1Phase 2NCT06727630

A Phase Ib Study of PRJ1-3024 for Treatment of Advanced or Metastatic Melanoma

A Phase Ib Study, Evaluating the Safety, Tolerance and Efficacy of PRJ1-3024 Capsules in China Subjects with Unresectable Local Advanced or Metastatic Melanoma


Sponsor

Zhuhai Yufan Biotechnologies Co., Ltd

Enrollment

40 participants

Start Date

Mar 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase Ib, open-label study to determine the safety and preliminary efficacy of PRJ1-3024 in China subjects with unresectable local advanced or metastatic melanoma


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1b study is testing a new oral medication called PRJ1-3024 in patients with advanced or metastatic melanoma (a type of skin cancer) whose cancer has progressed after at least one prior treatment. **You may be eligible if...** - You are 18 or older - You have confirmed advanced (cannot be surgically removed) or metastatic melanoma (excluding uveal/eye melanoma) - Your cancer has progressed or come back after at least one prior treatment - You are in good general health (ECOG 0-1) - You have at least one measurable tumor on scans - You have a life expectancy of at least 3 months - You are able to swallow pills **You may NOT be eligible if...** - You have had another cancer - You have significant heart disease - You have active hepatitis B, hepatitis C, or HIV - You received a live vaccine in the past 30 days - You have an active autoimmune condition or are on immunosuppressants - You received a previous HPK1 inhibitor (a specific drug class) - You are on strong CYP3A inhibitor or inducer medications that cannot be stopped Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPRJ1-3024

PRJ1-3024 is provided as capsules and is administered orally once a day


Locations(1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

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NCT06727630


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