A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors
NCT ID: NCT05315167
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
267 participants
INTERVENTIONAL
2022-05-30
2027-11-15
Brief Summary
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Detailed Description
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Participants with advanced solid tumor will receive PRJ1-3024 daily as an oral therapy and test the impact of of PRJ1-3024 on tumors.
This study will find the safe and tolerable recommended dose in subjects with advanced solid tumors in a open-label, 3+3 dose escalation study and use the RP2D to assess the preliminary efficacy of PRJ1-3024 in a long-term extension study.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Monotherapy Escalation
3+3 Dose escalation arm with PRJ1-3024 which will begin with 2 subjects treated at the lowest planned dose level. PRJ1-3024 is administered orally once daily. The starting dose is 80mg/day.
PRJ1-3024
PRJ1-3024 is provided as capsules and is administered orally once a day.
Monotherapy Exploration of the recommended dose
Upon completing Phase 1 and depending on data obtained, dose expansion may proceed in Phase 2 with several cohorts enrolled to confirm the tolerability of the RP2D of PRJ1-3024 (determined in Phase 1). PRJ1-3024 is administered orally once daily. The starting dose is determined by clinical effecacy data from Phase 1, and treatment may continue for up to 2 years as long as the subject experiences clinical benefit in the opinion of the Investigator and shows no signs or symptoms of unequivocal progression of disease.
PRJ1-3024
PRJ1-3024 is provided as capsules and is administered orally once a day.
Interventions
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PRJ1-3024
PRJ1-3024 is provided as capsules and is administered orally once a day.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Zhuhai Yufan Biotechnologies Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Hui ouyang, Dr.
Role: STUDY_DIRECTOR
VP
Locations
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The first affiliated hospital of Zhengzhou University
Zhengzhou, Henan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Cancer hospital of the University of Chinese Academy of Sciences
Hangzhou, Zhejiang, China
Beijing Cancer Hospital
Beijing, , China
The Fifth Medical Center of PLA General Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Yanru Qin
Role: primary
Yongsheng Wang
Role: primary
Ji Zhu
Role: primary
Lin Shen, Dr.
Role: primary
Guanghai Dai
Role: primary
Other Identifiers
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CXHL2101725
Identifier Type: OTHER
Identifier Source: secondary_id
PRJ1-3024-001
Identifier Type: -
Identifier Source: org_study_id