Actively Recruiting
A Phase Ib Study Evaluating the Safety, Tolerance, and Efficacy of PRJ1-3024 Capsules in Chinese Patients with Unresectable Local Advanced or Metastatic Melanoma
Led by Zhuhai Yufan Biotechnologies Co., Ltd · Updated on 2024-12-11
40
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating PRJ1-3024, a new oral drug that inhibits Hematopoietic progenitor kinase 1 (HPK-1), in adults with locally advanced or metastatic melanoma that cannot be removed by surgery. This Phase Ib, open-label study in China aims to assess the safety, tolerability, and early effectiveness of this treatment in patients who have already tried at least one standard therapy. The study also focuses on how the drug behaves in the body and its effects on the tumor. Participants will take PRJ1-3024 capsules orally once a day, starting at a dose of 300 mg. The study includes a dose escalation phase with 3 to 6 subjects to find the appropriate dose, followed by one or two dose backfill groups to further evaluate safety and efficacy. The treatment is tested specifically in Chinese patients with advanced melanoma that cannot be surgically removed or has spread. During the study, researchers will monitor tumor response, how long the response lasts, progression-free survival, and disease control rates over 24 months. They will also track pharmacokinetic data and any side effects. Participants must be willing to take the medication daily, attend regular visits, provide tissue samples, and complete assessments. The total observation period for outcomes and safety is 24 months from treatment start.
CONDITIONS
Brief Title
A Phase Ib Study of PRJ1-3024 for Treatment of Advanced or Metastatic Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed unresectable local advanced or metastatic melanoma (excluding ocular uveal melanoma) after at least one prior standard systemic therapy
- Male or non-pregnant, non-lactating female aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- At least one measurable lesion according to RECIST 1.1 criteria
- Life expectancy of at least 3 months as judged by the investigator
- Able to take oral medication and willing to record daily adherence
- Adequate blood, kidney, and liver function
- Able and willing to provide informed consent
- Consent to provide archived or fresh tissue sample
You will not qualify if you...
- History of another malignancy
- Symptomatic brain metastases requiring more than 10 mg/day prednisolone
- Significant cardiovascular disease
- Known active hepatitis B or C virus infection or AIDS-related illness
- Received live vaccine within 30 days
- History of active autoimmune disorders or ongoing immunosuppressive therapy
- Unresolved toxicities from prior treatments above Grade 2
- Receiving concurrent anti-cancer therapy, investigational products, or strong CYP3A inhibitors or inducers
- Prior treatment with other HPK1 inhibitors
- Allergy to study drug ingredients or other allergies deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive oral PRJ1-3024 capsules once daily to test safety, tolerability, and anti-tumor activity in advanced or metastatic melanoma.
Regular visits for monitoring during treatment
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
L
Liting Lai, Bachelor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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