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

Zhuhai Yufan Biotechnologies

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Melanoma

Treatments: Drug: PRJ1-3024

Study type: Interventional

Funder types: Industry

Identifiers

NCT06727630

PRJ1-3024-003

Details and patient eligibility

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

Full description

The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PRJ1-3024 and will determine the recommended dose in China subjects with unresectable local advanced or metastatic melanoma.

PRJ1-3024 is a small molecular Hematopoietic progenitor kinase (HPK-1) inhibitor. It will be evaluated as an oral therapeutic that tests the anti-tumor activity in patients with unresectable or metastatic melanoma and has not yet been tested in humans.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Monotherapy Escalation / Monotherapy Backfill

Experimental group

Description:

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.

Treatment:

Drug: PRJ1-3024