- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05315167
A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects With 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Using dose escalation, the study will evaluate the safety, tolerability, PK, and pharmacodynamics of PRJ1-3024 and will determine the maximum tolerated dose in subjects with advanced solid tumors.
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Liting Lai
- Phone Number: 8617728075858
- Email: vivi.lai@ming-med.com
Study Locations
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-
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Beijing, China, 100142
- Recruiting
- Beijing Cancer Hospital
-
Contact:
- Lin Shen, Dr.
- Phone Number: 8610-88196561
- Email: doctorshenlin@sina.com
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Beijing, China
- Recruiting
- The Fifth Medical Center of PLA General Hospital
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Henan
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Zhengzhou, Henan, China
- Recruiting
- The First Affiliated Hospital of Zhengzhou University
-
-
Sichuan
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Chengdu, Sichuan, China
- Recruiting
- West China Hospital of Sichuan University
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Contact:
- Yongsheng Wang
-
-
Zhejiang
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Hangzhou, Zhejiang, China
- Recruiting
- Cancer Hospital of The University of Chinese Academy of Sciences
-
Contact:
- Ji Zhu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 is provided as capsules and is administered orally once a day.
|
Experimental: 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 is provided as capsules and is administered orally once a day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period
Time Frame: Day 1 to Day 21
|
Safety listings and pharmacokinetic listings will be used for evaluation
|
Day 1 to Day 21
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events (AEs)
Time Frame: 24 months
|
Characterized by type, seriousness, relationship to study treatment, timing, and severity.
|
24 months
|
Objective response rate (ORR)
Time Frame: 24 months
|
estimated by the proportion of subjects having a complete response (CR) or partial response (PR) with use of RECIST v1.1 criteria.
|
24 months
|
Duration of response (DOR)
Time Frame: 24 months
|
defined as time from the first occurrence of a documented objective response to the time of relapse or death from any cause.
|
24 months
|
Pharmacokinetic parameter# Accumulation ratio
Time Frame: 24 months
|
to estimate the accumulation of PRJ1-3024 from time 0 to the time of last quantifiable concentration after multiple administration
|
24 months
|
Pharmacokinetic parameter#AUC0-last#
Time Frame: 24 months
|
Area under the concentration-time curve AUC from time 0 to the time of the last quantifiable concentration
|
24 months
|
Pharmacokinetic parameter#Maximum observed concentration (Cmax)
Time Frame: 24 months
|
assessed as time from time 0 to the time of the last quantifiable concentration
|
24 months
|
Collaborators and Investigators
Investigators
- Study Director: Hui ouyang, Dr., VP
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRJ1-3024-001
- CXHL2101725 (Other Identifier: CDE)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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