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

NCT05315167 | Recruiting Phase 1

• 2 other identifiers: PRJ1-3024-001CXHL2101725
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 5

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.

Conditions

Advanced Solid Tumor; Advanced Solid Malignancies

Keywords

Maximum tolerated dose; Recommended Phase 2 dose; Dose Escalation; Hematopoietic progenitor kinase 1; PRJ1-3024

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence of adverse events (AEs)

  24 months

• Pharmacokinetic parameter# Accumulation ratio

  24 months

• Objective response rate (ORR)

  24 months

• Duration of response (DOR)

  24 months

• Pharmacokinetic parameter#AUC0-last#

  24 months

Study Arms (2)

Monotherapy Escalation

EXPERIMENTAL

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.

Drug: PRJ1-3024

Monotherapy Exploration of the recommended dose

EXPERIMENTAL

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.

Drug: PRJ1-3024

Interventions

PRJ1-3024 DRUG

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

Monotherapy Escalation; Monotherapy Exploration of the recommended dose

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhuhai Yufan Biotechnologies Co., Ltd: lead

Study Sites (5)

The first affiliated hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

Cancer hospital of the University of Chinese Academy of Sciences

Hangzhou, Zhejiang, China

RECRUITING

Beijing Cancer Hospital

Beijing, 100142, China

RECRUITING

The Fifth Medical Center of PLA General Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Hereditary Sensory and Autonomic Neuropathies

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Hui ouyang, Dr.

  VP

  STUDY DIRECTOR

Central Study Contacts

Liting Lai

CONTACT

8617728075858; vivi.lai@ming-med.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 is a Phase 1, open label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024. Upon completing Phase 1 and depending on data obtained, dose expansion may proceed in Phase 2 to confirm the tolerability and efficacy of the RP2D of PRJ1-3024 .

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 7, 2022
• Study Start: May 30, 2022
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): November 15, 2027
• Last Updated: December 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)