A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2025-03-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, open-label study to assess the safety and preliminary efficacy and to determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and recommended Phase 2 doses (RP2D) of PRJ1-3024 in subjects with relapsed/refractory solid tumors. The study consists of two parts, one is a 3+3 dose escalation study and another is a pharmaceutical extension of RP2D.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhuhai Yufan Biotechnologies Co., Ltd

Criteria

• Key Inclusion Criteria:

• Histologically or cytologically confirmed locally advanced (unresectable) or metastatic r/r solid tumors for which no standard therapy is available or for whom standard therapy is considered unsuitable or intolerable.

• Male or non-pregnant, non-lactating female subjects age ≥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 unless clearly due to the disease under study.

• Adequate renal and hepatic function

• Able to understand and willing to sign a written informed consent form.

Key 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 or ongoing .

• 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 hematopoietic progenitor kinase 1 (HPK1) inhibitors.