Actively Recruiting
A Phase 1/2 Open-label Study Assessing the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PRJ1-3024 in Advanced Solid Tumors
Led by Zhuhai Yufan Biotechnologies Co., Ltd · Updated on 2024-12-17
267
Participants Needed
5
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying PRJ1-3024, an oral drug, in people with advanced solid tumors that have returned or do not respond to standard treatments. This open-label Phase 1/2 trial aims to assess the safety, tolerability, how the body processes the drug, and its preliminary effects on tumors. The study will also determine the highest dose that patients can tolerate and recommend doses for further research. The study has two parts: a dose escalation phase and an extension phase. In the first phase, small groups of participants receive increasing doses of PRJ1-3024 taken once daily starting at 80 mg to identify the maximum tolerated dose. Afterward, the extension phase uses the recommended dose from the first part to evaluate longer-term safety and preliminary effectiveness. Treatment can continue for up to two years if patients benefit and do not show clear disease progression. Participants will take PRJ1-3024 orally daily and be monitored closely for side effects and tumor response. Researchers will track dose-limiting toxicities during the first 21 days and observe adverse events, drug levels in the body, tumor shrinkage, and response duration over up to 24 months. The study includes regular assessments and requires participants to record their medication adherence. The total participation duration varies based on individual response and tolerability.
CONDITIONS
Brief Title
A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced or metastatic relapsed/refractory solid tumors without suitable standard therapy
- Male or non-pregnant, non-lactating female aged 18 years or older
- ECOG Performance Status 0 to 1
- At least one measurable lesion by RECIST 1.1 criteria
- Life expectancy greater than 3 months as judged by the investigator
- Able and willing to take oral medications daily and record adherence
- Adequate hematologic, renal, and hepatic function
- Able to understand and willing to sign informed consent
You will not qualify if you...
- History of another malignancy
- Symptomatic brain metastases requiring more than 10 mg/day of prednisolone
- Significant cardiovascular disease
- Known active hepatitis B or C virus infection or AIDS-related illness
- Received a live vaccine within 30 days
- History of active autoimmune disorders or ongoing immunosuppressive therapy
- Unresolved toxicities from prior cancer therapies greater than Grade 2
- Receiving concurrent anti-cancer therapies or strong CYP3A inhibitors or inducers
- Prior treatment with hematopoietic progenitor kinase 1 (HPK1) inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 weeks
Participants receive daily oral doses of PRJ1-3024 starting at the lowest dose level to evaluate safety and determine the maximum tolerated dose.
Multiple visits during dose escalation period
Duration - Up to 2 years or until disease progression or unacceptable toxicity
Participants receive daily oral PRJ1-3024 at the recommended Phase 2 dose to assess preliminary efficacy and long-term tolerability.
Regular visits throughout treatment period
Trial Site Locations
Total: 5 locations
1
The first affiliated hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
2
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
3
Cancer hospital of the University of Chinese Academy of Sciences
Hangzhou, Zhejiang, China
Actively Recruiting
4
Beijing Cancer Hospital
Beijing, China, 100142
Actively Recruiting
5
The Fifth Medical Center of PLA General Hospital
Beijing, China
Actively Recruiting
Research Team
L
Liting Lai
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here