Treatment of advanced melanoma with PRJ1-3024

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 study is testing a new oral medication called PRJ1-3024 to see if it can safely help people with advanced melanoma that can't be surgically removed.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhuhai Yufan Biotechnologies Co., Ltd (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06727630 on ClinicalTrials.gov

What this trial studies

This Phase Ib study evaluates the safety and preliminary efficacy of PRJ1-3024, an oral HPK-1 inhibitor, in patients with unresectable local advanced or metastatic melanoma. The study aims to determine the recommended dose and assess pharmacokinetics and pharmacodynamics in a Chinese population. Participants will be monitored for tolerability and anti-tumor activity after receiving the investigational drug.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed unresectable or metastatic melanoma who have progressed after at least one prior systemic therapy.

Not a fit: Patients with a history of another malignancy or significant cardiovascular disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced melanoma who have limited treatment choices.

How similar studies have performed: While this approach is novel and has not been tested in humans before, similar studies with HPK-1 inhibitors have shown promise in preclinical models.

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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Liting Lai, Bachelor

Conditions Melanoma; HPK-1 inhibitor; melanoma; PRJ1-3024; Recommended Phase 2 dose