A Phase Ib Study, Evaluating the Safety, Tolerance and Efficacy of PRJ1-3024 Capsules in China Subjects with Unresectable Local Advanced or Metastatic Melanoma
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male or non-pregnant, non-lactating female subjects aged ≥18 years.
• ECOG Performance Status 0\
• 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.
Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Contact Information
Primary
Liting Lai, Bachelor
vivi.lai@ming-med.com
8617728075858
Time Frame
Start Date: 2024-03-14
Estimated Completion Date: 2025-10-30
Participants
Target number of participants: 40
Treatments
Experimental: Monotherapy Escalation / Monotherapy Backfill
Dose escalation arm with PRJ1-3024 which will begin with 3-6 subjects treated at the lowest planned dose level based on previous phase Ia study results. PRJ1-3024 is administered orally once daily. The starting dose is 300mg/day.~After the small dose escalation, one or two dose backfill group will be tested to further explore the efficacy and safety of China patients with unresectable local advanced or metastatic melanoma.
Related Therapeutic Areas
Sponsors
Leads: Zhuhai Yufan Biotechnologies Co., Ltd