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PRJ1-3024 for Cancer

Phase 1
Recruiting
Research Sponsored by Zhuhai Yufan Biotechnologies Co., Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
ECOG Performance Status 0~2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and works well against cancer in patients who have tried other treatments that didn't work.

Who is the study for?
Adults (≥18 years) with advanced solid tumors that are untreatable by standard therapies or when such treatments aren't suitable. Participants must have a measurable tumor, be able to take oral meds and track their use, have a life expectancy over 3 months, and proper organ function. They should not have other cancers, significant heart disease, active hepatitis or HIV infections, recent live vaccines, autoimmune diseases on immunosuppressants, or current cancer treatments.Check my eligibility
What is being tested?
The trial is testing PRJ1-3024's safety and early effectiveness in patients with relapsed/refractory solid tumors. It's an open-label study where everyone gets the drug; doses increase until they find the highest dose patients can safely take without severe side effects ('dose escalation').See study design
What are the potential side effects?
Specific side effects of PRJ1-3024 aren't listed but may include typical reactions to cancer drugs like nausea, fatigue, blood count changes leading to increased infection risk or bleeding problems. Organ inflammation and allergic reactions could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced cancer has no standard treatment options left.
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I can take care of myself and am up and about more than half of my waking hours.
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I can take pills and am willing to track my medication use daily.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period
Secondary outcome measures
Duration of response (DOR)
Incidence of adverse events (AEs)
Objective response rate (ORR)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Monotherapy EscalationExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Zhuhai Yufan Biotechnologies Co., LtdLead Sponsor
1 Previous Clinical Trials
267 Total Patients Enrolled
Yang Xu, PhDStudy DirectorHead of US Clinical Development
Steven Cha, MDStudy DirectorSVP, Oncology

Media Library

PRJ1-3024 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05159700 — Phase 1
Solid Tumors Research Study Groups: Monotherapy Escalation
Solid Tumors Clinical Trial 2023: PRJ1-3024 Highlights & Side Effects. Trial Name: NCT05159700 — Phase 1
PRJ1-3024 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05159700 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is PRJ1-3024 a viable treatment option with minimal risk to users?

"Because PRJ1-3024 is in Phase 1, meaning there are limited data points attesting to its safety and efficacy, we at Power rate the medication's safety as a relatively low score of 1."

Answered by AI

What is the geographic scope of this scientific inquiry?

"Currently, this medical experiment is taking place in 5 different cities. Some of them being Denver, Fairfax and Austin among other urban hubs. It would be beneficial to select the location closest to you so as to limit travel necessity should one decide to participate."

Answered by AI

Are there any opportunities for patients to join this trial?

"Affirmative. As noted on clinicaltrials.gov, this medical research is actively looking for volunteers to participate in the trial that was originally posted on March 31st 2022 and most recently updated August 9th 2022. 46 individuals must be recruited between 5 different treatment sites."

Answered by AI

How many subjects are currently enrolled in this clinical experiment?

"In order to conduct the trial, 46 participants must meet its prerequisites. The sponsor of this study is Zhuhai Yufan Biotechnologies Co., Ltd and it will be carried out at Sarah Cannon Research Institute in Denver, Colorado and NEXT Oncology in Fairfax, Virginia."

Answered by AI
~16 spots leftby Mar 2025