PRJ1-3024 for Cancer
Trial Summary
What is the purpose of this trial?
This trial tests a new oral medicine, PRJ1-3024, on patients with advanced solid tumors that have not responded to other treatments. The study aims to find a safe dose and see if the medicine can shrink or stop tumor growth.
Will I have to stop taking my current medications?
The trial requires that you stop taking any current anti-cancer therapy or investigational products. It also excludes those taking strong inhibitors or inducers of a specific enzyme (CYP3A).
What data supports the effectiveness of the drug PRJ1-3024 for cancer?
What safety data exists for the treatment PRJ1-3024 or similar CXCR4 antagonists?
The safety of CXCR4 antagonists, which may include treatments like PRJ1-3024, has been evaluated in mouse models. These models showed that mice with human-like CXCR4 were healthy and reproduced normally, suggesting a level of safety in these animals. However, detailed human safety data would typically be assessed in later stages of clinical trials.678910
How does the drug PRJ1-3024 differ from other cancer treatments?
Research Team
Yang Xu, PhD
Principal Investigator
Head of US Clinical Development
Eligibility Criteria
Adults (≥18 years) with advanced solid tumors that are untreatable by standard therapies or when such treatments aren't suitable. Participants must have a measurable tumor, be able to take oral meds and track their use, have a life expectancy over 3 months, and proper organ function. They should not have other cancers, significant heart disease, active hepatitis or HIV infections, recent live vaccines, autoimmune diseases on immunosuppressants, or current cancer treatments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
3+3 dose escalation study to determine the maximum tolerated dose of PRJ1-3024
Treatment
Participants receive PRJ1-3024 orally once daily to evaluate safety, tolerability, and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- PRJ1-3024
Find a Clinic Near You
Who Is Running the Clinical Trial?
Zhuhai Yufan Biotechnologies Co., Ltd
Lead Sponsor