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Recruiting NCT06727630

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

Phase I / Phase II Interventional Melanoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PRJ1-3024.
Who it may be relevant to
Registry conditions: Melanoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Objective response rate (ORR) [Time frame: 24 months]
  • Recommended phase 2 dose (RP2D) [Time frame: 24 months]
Secondary outcome measures (8)
  • Duration of response (DOR) [Time frame: 24 months]
  • Progression-Free Survival (PFS) [Time frame: 24 months]
  • Disease control rate (DCR) [Time frame: 24 months]
  • Pharmacokinetic parameters (PK) [Time frame: 24 months]
  • Incidence of adverse events (AEs) [Time frame: 24 months]
  • Pharmacokinetic parameters (PK) [Time frame: 24 months]
  • Pharmacokinetic parameters (PK) [Time frame: 24 months]
  • Pharmacokinetic parameters(PK) [Time frame: 24 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Cancer Hospital — Beijing

Identifiers

NCT: NCT06727630 · PRJ1-3024-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗