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

Z

Zhuhai Yufan Biotechnologies

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Advanced Solid Tumor
Advanced Solid Malignancies

Treatments

Drug: PRJ1-3024

Study type

Interventional

Funder types

Industry

Identifiers

NCT05315167
CXHL2101725 (Other Identifier)
PRJ1-3024-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

267 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

267 participants in 2 patient groups

Monotherapy Escalation
Experimental group
Description:
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.
Treatment:
Drug: PRJ1-3024
Monotherapy Exploration of the recommended dose
Experimental group
Description:
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.
Treatment:
Drug: PRJ1-3024

Trial contacts and locations

5

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Central trial contact

Liting Lai

Data sourced from clinicaltrials.gov

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