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

NCT06727630 | Recruiting Phase 1

• 1 other identifier: PRJ1-3024-003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Melanoma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Duration of response (DOR)

  24 months

• Progression-Free Survival (PFS)

  24 months

• Disease control rate (DCR)

  24 months

• Pharmacokinetic parameters (PK)

  24 months

• Incidence of adverse events (AEs)

  24 months

Study Arms (1)

Monotherapy Escalation / Monotherapy Backfill

EXPERIMENTAL

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

Interventions

PRJ1-3024 DRUG

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

Monotherapy Escalation / Monotherapy Backfill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhuhai Yufan Biotechnologies Co., Ltd: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hui Ouyang, Dr.

  VP

  STUDY DIRECTOR

Central Study Contacts

Liting Lai, Bachelor

CONTACT

8617728075858; vivi.lai@ming-med.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 11, 2024
• Study Start: March 14, 2024
• Primary Completion: April 30, 2025
• Study Completion: October 30, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)