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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05315167
• Other study ID #: PRJ1-3024-001
• Secondary ID: CXHL2101725
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 30, 2022
• Est. completion date: March 15, 2025

Study information

• Verified date: July 2022
• Source: Zhuhai Yufan Biotechnologies Co., Ltd
• Contact: Liting Lai
• Phone: 8617728075858
• Email: vivi.lai[@]ming-med.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 267
• Est. completion date: March 15, 2025
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Advanced Solid Malignancies
• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• PRJ1-3024
PRJ1-3024 is provided as capsules and is administered orally once a day.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing
China	The Fifth Medical Center of PLA General Hospital	Beijing
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Cancer hospital of the University of Chinese Academy of Sciences	Hangzhou	Zhejiang
China	The first affiliated hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Zhuhai Yufan Biotechnologies Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period	Safety listings and pharmacokinetic listings will be used for evaluation	Day 1 to Day 21
Secondary	Incidence of adverse events (AEs)	Characterized by type, seriousness, relationship to study treatment, timing, and severity.	24 months
Secondary	Pharmacokinetic parameter# Accumulation ratio	to estimate the accumulation of PRJ1-3024 from time 0 to the time of last quantifiable concentration after multiple administration	24 months
Secondary	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
Secondary	Duration of response (DOR)	defined as time from the first occurrence of a documented objective response to the time of relapse or death from any cause.	24 months
Secondary	Pharmacokinetic parameter#AUC0-last#	Area under the concentration-time curve AUC from time 0 to the time of the last quantifiable concentration	24 months
Secondary	Pharmacokinetic parameter#Maximum observed concentration (Cmax)	assessed as time from time 0 to the time of the last quantifiable concentration	24 months