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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
Must not have
Receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome P450 3A (CYP3A)
Known symptomatic brain metastases requiring >10 mg/day of prednisolone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new oral medicine, PRJ1-3024, on patients with advanced solid tumors that have not responded to other treatments. The study aims to find a safe dose and see if the medicine can shrink or stop tumor growth.
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.
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').
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not taking any cancer treatments, trial drugs, or specific enzyme inhibitors.
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I need more than 10 mg/day of prednisolone for my brain metastases.
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I have a serious heart condition.
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I have not received a live vaccine in the last 30 days.
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I have had another type of cancer in the past.
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I have an active autoimmune disorder or am on immunosuppressive therapy.
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I have not been treated with HPK1 inhibitors before.
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I do not have active hepatitis B, hepatitis C, or AIDS.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period
Secondary study objectives
Duration of response (DOR)
Incidence of adverse events (AEs)
Objective response rate (ORR)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects.
Targeted therapy involves drugs designed to specifically target molecular pathways critical for tumor growth and survival, such as tyrosine kinase inhibitors that block signals needed for tumors to grow. Immunotherapy leverages the body's immune system to recognize and destroy cancer cells, using agents like checkpoint inhibitors to enhance immune response.
These mechanisms are crucial for solid tumor patients, especially those with relapsed or refractory disease, as they offer different strategies to control tumor growth, manage symptoms, and potentially improve survival outcomes.
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Who is running the clinical trial?
Zhuhai Yufan Biotechnologies Co., LtdLead Sponsor
1 Previous Clinical Trials
267 Total Patients Enrolled
Steven Cha, MDStudy DirectorSVP, Oncology
Fred OuyangStudy DirectorSr. VP, R& D
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any cancer treatments, trial drugs, or specific enzyme inhibitors.My kidney and liver are functioning well.I can take care of myself and am up and about more than half of my waking hours.My advanced cancer has no standard treatment options left.I need more than 10 mg/day of prednisolone for my brain metastases.I have a serious heart condition.I have not received a live vaccine in the last 30 days.I have had another type of cancer in the past.I have an active autoimmune disorder or am on immunosuppressive therapy.I have not been treated with HPK1 inhibitors before.I am an adult over 18 and not pregnant or breastfeeding.I can take pills and am willing to track my medication use daily.I do not have active hepatitis B, hepatitis C, or AIDS.
Research Study Groups:
This trial has the following groups:- Group 1: Monotherapy Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.