Clinical trial NCT06727630: A Phase Ib Study of PRJ1-3024 for Treatment of Advanced or Metastatic Melanoma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Melanoma
Keywords: HPK-1 inhibitor;melanoma;PRJ1-3024;Recommended Phase 2 dose
Lead sponsor: Zhuhai Yufan Biotechnologies Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-12-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 24 months
measure: Recommended phase 2 dose (RP2D)
timeFrame: 24 months
Secondary outcomes:
measure: Duration of response (DOR)
timeFrame: 24 months
measure: Progression-Free Survival (PFS)
timeFrame: 24 months
measure: Disease control rate (DCR)
timeFrame: 24 months
measure: Pharmacokinetic parameters (PK)
timeFrame: 24 months
measure: Incidence of adverse events (AEs)
timeFrame: 24 months
measure: Pharmacokinetic parameters (PK)
timeFrame: 24 months
measure: Pharmacokinetic parameters (PK)
timeFrame: 24 months
measure: Pharmacokinetic parameters(PK)
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: VP
name: Hui Ouyang, Dr.
role: STUDY_DIRECTOR
References: