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

Launched by ZHUHAI YUFAN BIOTECHNOLOGIES CO., LTD · Apr 5, 2022

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called PRJ1-3024 for patients with advanced solid tumors, which are types of cancer that have spread and for which standard treatments are not suitable or effective. The trial is in its early stages (Phase I/II) and aims to find out how safe the treatment is, how the body processes it, and if it can help shrink the tumors. It includes two parts: one that gradually increases the dose to find the highest amount that can be given safely, and another that continues with the recommended dose for further study.

To participate in this trial, patients must be at least 18 years old and have a confirmed diagnosis of a solid tumor that is either locally advanced or has spread and has not responded to previous treatments. They should have at least one measurable tumor, be able to take medications by mouth, and have a life expectancy of more than three months. Participants can expect close monitoring throughout the study and will need to keep track of their medication adherence. It’s important to know that individuals with certain health conditions, like active infections, significant heart disease, or those currently receiving other cancer treatments, may not be eligible to join.

Gender

ALL

Eligibility 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.