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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllZhuhai Yufan Biotechnologies Co., Ltd
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria:• Histologically or cytologically confirmed locally advanced (unresectable) or metastatic melanoma (with the exception of ocular uveal melanoma). Patients who have progressed or relapsed after at least 1st-line systemic standard therapy. * Male or non-pregnant, non-lactating female subjects aged ≥18 years. * ECOG Performance Status 0\~1. * Has at least 1 measurable lesion as defined by RECIST 1.1 criteria. * Life expectancy of ≥3 months, in the opinion of the Investigator. * Able to take oral medications and willing to record daily adherence to investigational product. * Adequate hematologic parameters. * Adequate renal and hepatic function * Able to understand and willing to sign a written informed consent form. * Consent to provide archived tissue specimen or tissue sample. Exclusion Criteria:• History of another malignancy. * Known symptomatic brain metastases requiring \>10 mg/day of prednisolone. * Significant cardiovascular disease. * Known active HBV, HCV, AIDS-related illness. * Has received a live vaccine within 30 days. * History of active autoimmune disorders, or ongoing immunosuppressive therapy. * Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to \< Grade 2. * Receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome P450 3A (CYP3A) . * Prior treatment with other hematopoietic progenitor kinase 1 (HPK1) inhibitors. * Allergy to the ingredients of study drug, or a history of other allergies which were judged by the investigator to be unsuitable for participation in the study.
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What it tests

  • PRJ1-3024
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Where

1 site
Beijing Cancer Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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