A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Prime Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors

Zhuhai Yufan Biotechnologies Co., Ltd5 sites in 1 country267 target enrollmentMay 30, 2022

ConditionsAdvanced Solid Tumor Advanced Solid Malignancies

InterventionsPRJ1-3024

DrugsPRJ1-3024

Overview

Phase: Phase 1
Intervention: PRJ1-3024
Conditions: Advanced Solid Tumor
Sponsor: Zhuhai Yufan Biotechnologies Co., Ltd
Enrollment: 267
Locations: 5
Primary Endpoint: Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

Using dose escalation, the study will evaluate the safety, tolerability, PK, and pharmacodynamics of PRJ1-3024 and will determine the maximum tolerated dose in subjects with advanced solid tumors. Participants with advanced solid tumor will receive PRJ1-3024 daily as an oral therapy and test the impact of of PRJ1-3024 on tumors. This study will find the safe and tolerable recommended dose in subjects with advanced solid tumors in a open-label, 3+3 dose escalation study and use the RP2D to assess the preliminary efficacy of PRJ1-3024 in a long-term extension study.

Registry

clinicaltrials.gov

Start Date

May 30, 2022

End Date

November 15, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Zhuhai Yufan Biotechnologies Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

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\~
•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.

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
•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.

Arms & Interventions

Monotherapy Escalation

3+3 Dose escalation arm with PRJ1-3024 which will begin with 2 subjects treated at the lowest planned dose level. PRJ1-3024 is administered orally once daily. The starting dose is 80mg/day.

Intervention: PRJ1-3024

Monotherapy Exploration of the recommended dose

Upon completing Phase 1 and depending on data obtained, dose expansion may proceed in Phase 2 with several cohorts enrolled to confirm the tolerability of the RP2D of PRJ1-3024 (determined in Phase 1). PRJ1-3024 is administered orally once daily. The starting dose is determined by clinical effecacy data from Phase 1, and treatment may continue for up to 2 years as long as the subject experiences clinical benefit in the opinion of the Investigator and shows no signs or symptoms of unequivocal progression of disease.

Intervention: PRJ1-3024