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

A Phase Ib Study, Evaluating the Safety, Tolerance and Efficacy of PRJ1-3024 Capsules in China Subjects with Unresectable Local Advanced or Metastatic Melanoma

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

Study Overview

• Status: Recruiting
• Conditions: Melanoma
• Intervention / Treatment: Drug: PRJ1-3024

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Liting Lai, Bachelor; Phone Number: 8617728075858; Email: vivi.lai@ming-med.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Jun Guo, Dr; Phone Number: 8610-88196348; Email: guoj307@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Drug: PRJ1-3024; PRJ1-3024 is provided as capsules and is administered orally once a day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhuhai Yufan Biotechnologies Co., Ltd
• Investigators: Study Director: Hui ouyang, Dr., VP

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Estimated): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: HPK-1 inhibitor;melanoma;PRJ1-3024;Recommended Phase 2 dose
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Melanoma
• Other Study ID Numbers: PRJ1-3024-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No