Actively Recruiting
A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors
Led by Zhuhai Yufan Biotechnologies Co., Ltd · Updated on 2024-12-17
267
Participants Needed
5
Research Sites
285 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label study to assess the safety and preliminary efficacy and to determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and recommended Phase 2 doses (RP2D) of PRJ1-3024 in subjects with relapsed/refractory solid tumors. The study consists of two parts, one is a 3+3 dose escalation study and another is a pharmaceutical extension of RP2D.
CONDITIONS
Official 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 (unresectable) or metastatic relapsed/refractory solid tumors with no suitable standard therapy
- Male or non-pregnant, non-lactating female subjects aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- At least one measurable lesion as defined by RECIST 1.1 criteria
- Life expectancy greater than 3 months as judged by the investigator
- Ability to take oral medications and willingness to record daily adherence to the study drug
- Adequate blood cell counts unless related to the cancer
- Adequate kidney and liver function
- Ability to understand and willingness to sign informed consent form
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, hepatitis C, or AIDS-related illness
- Receipt of a live vaccine within 30 days prior to study entry
- History of active autoimmune disorders or ongoing immunosuppressive therapy
- Persistent toxicities from prior radiotherapy or chemotherapy not recovered to less than Grade 2
- Receiving concurrent anti-cancer therapy, investigational products, or strong CYP3A inhibitors or inducers
- Prior treatment with hematopoietic progenitor kinase 1 (HPK1) inhibitors
AI-Screening
AI-Powered Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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