A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors
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., Ltd
267 participants
May 30, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- 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.
Exclusion Criteria9
- 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.
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Interventions
PRJ1-3024 is provided as capsules and is administered orally once a day.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05315167