A Phase 1/2 interventional study of PRJ1-3024 in Advanced Solid Tumor and Advanced Solid Malignancies, sponsored by Zhuhai Yufan Biotechnologies Co., Ltd. Recruiting at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-17.
Sponsored by Zhuhai Yufan Biotechnologies Co., Ltd · Phase 1/2, Interventional, and Treatment
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.
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.
9,371 studies on the registry are indexed under Neoplasms; 2,492 are open to participants now.
This study's planned enrollment of 267 is above the median of 50 across 7,258 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Zhuhai Yufan Biotechnologies Co., Ltd is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Exclusion Criteria:
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.
Drug: PRJ1-3024
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.
Drug: PRJ1-3024
PRJ1-3024 is provided as capsules and is administered orally once a day.
Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period
Safety listings and pharmacokinetic listings will be used for evaluation
Time frame: Day 1 to Day 21
Incidence of adverse events (AEs)
Characterized by type, seriousness, relationship to study treatment, timing, and severity.
Time frame: 24 months
Pharmacokinetic parameter# Accumulation ratio
to estimate the accumulation of PRJ1-3024 from time 0 to the time of last quantifiable concentration after multiple administration
Time frame: 24 months
Objective response rate (ORR)
estimated by the proportion of subjects having a complete response (CR) or partial response (PR) with use of RECIST v1.1 criteria.
Time frame: 24 months
Duration of response (DOR)
defined as time from the first occurrence of a documented objective response to the time of relapse or death from any cause.
Time frame: 24 months
Pharmacokinetic parameter#AUC0-last#
Area under the concentration-time curve AUC from time 0 to the time of the last quantifiable concentration
Time frame: 24 months
Pharmacokinetic parameter#Maximum observed concentration (Cmax)
assessed as time from time 0 to the time of the last quantifiable concentration
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Zhuhai Yufan Biotechnologies Co., Ltd