Evaluating PRJ1-3024 for 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
This study is testing a new oral treatment called PRJ1-3024 to see if it is safe and effective for people with advanced solid tumors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 267 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zhuhai Yufan Biotechnologies Co., Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Zhengzhou, Henan and 4 other locations) |
| Trial ID | NCT05315167 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label study aims to assess the safety, pharmacokinetics, and preliminary efficacy of PRJ1-3024 in patients with advanced solid tumors. The study employs a 3+3 dose escalation design to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Participants will receive PRJ1-3024 daily as an oral therapy, and the study will evaluate its impact on measurable tumors. The findings will help establish a safe and tolerable dose for further investigation in a long-term extension study.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed advanced solid tumors that are unresectable or metastatic and for whom standard therapies are unsuitable.
Not a fit: Patients with a history of another malignancy or significant cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have limited or no available therapies.
How similar studies have performed: Other studies have shown promise with similar dose escalation approaches in treating advanced solid tumors, suggesting potential for success in this novel intervention.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Zhengzhou, Henan and 4 other locations
- The first affiliated hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
- West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
- Cancer hospital of the University of Chinese Academy of Sciences — Hangzhou, Zhejiang, China (Recruiting)
- Beijing Cancer Hospital — Beijing, China (Recruiting)
- The Fifth Medical Center of PLA General Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Liting Lai
- Email: vivi.lai@ming-med.com
- Phone: 8617728075858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.