Actively Recruiting
A Phase Ib Study of PRJ1-3024 for Treatment of Advanced or Metastatic Melanoma
Led by Zhuhai Yufan Biotechnologies Co., Ltd · Updated on 2024-12-11
40
Participants Needed
1
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 locally advanced or metastatic melanoma (excluding ocular uveal melanoma)
- Progressed or relapsed after at least first-line systemic standard therapy
- Male or non-pregnant, non-lactating female aged 18 years or older
- ECOG Performance Status of 0 to 1
- At least one measurable lesion as defined by RECIST 1.1
- Life expectancy of 3 months or more as judged by investigator
- Able to take oral medications and willing to record daily adherence
- Adequate blood counts
- Adequate kidney and liver function
- Able to understand and willing to sign informed consent
- Consent to provide archived tissue specimen or tissue sample
You will not qualify if you...
- History of another malignancy
- Known symptomatic brain metastases requiring more than 10 mg/day of prednisolone
- Significant cardiovascular disease
- Known active hepatitis B, hepatitis C, or AIDS-related illness
- Received a live vaccine within 30 days
- History of active autoimmune disorders or ongoing immunosuppressive therapy
- Toxicities from prior radiotherapy or chemotherapy not recovered to less than 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 unsuitable for participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
L
Liting Lai, Bachelor
CONTACT
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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