Evaluating PRJ1-3024 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

\- 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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.