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

Phase 1

Recruiting

• Conditions: Melanoma
• Interventions: Drug: PRJ1-3024

• Registration Number: NCT06727630
• Lead Sponsor: Zhuhai Yufan Biotechnologies Co., Ltd

Brief 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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-03-14
• Status Verified: 2024-10
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-04-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Monotherapy Escalation / Monotherapy Backfill	PRJ1-3024	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.

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	24 months	Estimated by the proportion of subjects having a complete response (CR) or partial response (PR) with use of RECIST v1.1 criteria.
Recommended phase 2 dose (RP2D)	24 months	To determine the RP2D in China advanced metastatic melanoma patients

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters (PK)	24 months	Time to peak drug concentration(Tmax)
Incidence of adverse events (AEs)	24 months	Characterized by type, seriousness, relationship to study treatment, timing, and severity
Pharmacokinetic parameters(PK)	24 months	Area under the plasma concentration versus time curve (AUC)
Duration of response (DOR)	24 months	Defined as time from the first occurrence of a documented objective response to the time of relapse or death from and cause.
Progression-Free Survival (PFS)	24 months	Calculated from the start of treatment until the first occurrence of disease progression or death, whichever comes first.
Disease control rate (DCR)	24 months	To access the response of patients, particularly whether the treatment is able to shrink or stabilize the tumor.

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China