PRJ1-3024 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and initial effectiveness of a new treatment called PRJ1-3024 for people with solid tumors that have returned or don't respond to usual treatments. Participants take the medication orally each day, starting at a low dose, to assess tolerance. The study seeks individuals with advanced or spreading solid tumors who haven't found other treatments effective or suitable. Participants must be able to take daily medication and have a life expectancy of more than three months. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.
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).
Is there any evidence suggesting that PRJ1-3024 is likely to be safe for humans?
Research has shown that PRJ1-3024 is generally safe for patients with advanced solid tumors. In a study with Chinese patients, the treatment proved safe, and researchers continue to study its effects. This trial is in its early stages, focusing primarily on safety. The treatment aims to boost the body's immune response against tumors. So far, PRJ1-3024 has not presented major safety issues, but researchers are still determining the optimal dose.12345
Why do researchers think this study treatment might be promising?
PRJ1-3024 is unique because it is designed to be taken orally once a day, which can be more convenient and less invasive than many current cancer treatments that require intravenous administration. Unlike traditional chemotherapy, which often attacks both cancerous and healthy cells, PRJ1-3024 is expected to selectively target cancer cells, potentially reducing side effects. Researchers are excited about its novel dosing strategy, starting with a low dose and carefully increasing, which aims to maximize effectiveness while minimizing risk.
What evidence suggests that PRJ1-3024 might be an effective treatment for cancer?
Research has shown that PRJ1-3024 could be a promising treatment for solid tumors. It blocks HPK1, an enzyme that aids cancer growth. Studies have found that PRJ1-3024 is generally safe, with few serious side effects reported. While detailed efficacy results are still pending, early findings suggest it might influence tumor activity. In this trial, participants will receive PRJ1-3024 in a monotherapy escalation arm to determine the optimal dose and assess its initial effects on tumors.13456
Who Is on the Research Team?
Yang Xu, PhD
Principal Investigator
Head of US Clinical Development
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- PRJ1-3024
Find a Clinic Near You
Who Is Running the Clinical Trial?
Zhuhai Yufan Biotechnologies Co., Ltd
Lead Sponsor