Status:
RECRUITING
A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors
Lead Sponsor:
Zhuhai Yufan Biotechnologies Co., Ltd
Conditions:
Advanced Solid Tumor
Advanced Solid Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 dos...
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. Pa...
Eligibility Criteria
Inclusion
- \- Key
- 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
- 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.
Key Trial Info
Start Date :
May 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2027
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT05315167
Start Date
May 30 2022
End Date
November 15 2027
Last Update
December 17 2024
Active Locations (5)
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1
The first affiliated hospital of Zhengzhou University
Zhengzhou, Henan, China
2
West China Hospital of Sichuan University
Chengdu, Sichuan, China
3
Cancer hospital of the University of Chinese Academy of Sciences
Hangzhou, Zhejiang, China
4
Beijing Cancer Hospital
Beijing, China, 100142