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PRMT5 Inhibitor
AZD3470 for Advanced Solid Cancers (PRIMROSE Trial)
Phase 1 & 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the ICF.
Participants must have received and progressed, are refractory or are intolerant to standard therapy for the specific tumour type. All participants are required to have had at least one prior line of treatment in the recurrent or metastatic setting.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first dose of azd3470 up until the date of death due to any cause (approximately 2 years).
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called AZD3470 in patients with advanced cancers that have a specific genetic issue. The goal is to see if the drug is safe, well-tolerated, and effective in stopping or slowing down cancer growth. AZD3470 is being tested for its potential to treat cancers with this genetic issue, which has been linked to a dependency on a specific protein, making it a target for new cancer therapies.
Who is the study for?
This trial is for adults with advanced or metastatic solid tumors that lack MTAP, a specific gene. Participants must have tried standard treatments without success and should be in fairly good health (able to perform daily activities with ease or some limitation). They need at least one tumor that can be measured by medical scans and should expect to live at least 12 more weeks.
What is being tested?
The study tests AZD3470, a new drug targeting PRMT5 enzymes in patients whose tumors don't have the MTAP gene. It's an early-phase trial assessing how safe the drug is, how well it's tolerated, its pharmacokinetics (how it moves through the body), effects on the body, and initial signs of effectiveness.
What are the potential side effects?
Since this is a first-in-human study for AZD3470, detailed side effects are not yet known. However, participants may experience typical cancer treatment-related side effects such as fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 18 years old or the legal age of consent where the study is conducted.
Select...
My cancer has not responded to or I cannot tolerate the standard treatment, and I have had at least one treatment for it when it came back or spread.
Select...
My tumor lacks MTAP due to gene deletion or no MTAP protein expression.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of first dose of azd3470 up until the date of death due to any cause (approximately 2 years).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first dose of azd3470 up until the date of death due to any cause (approximately 2 years).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Incidence of dose-limiting toxicities (DLT)
Secondary study objectives
Module 1 Endpoints Part A (DDI) - Measurement of PK parameters of Dextromethorphan: AUC
Module 1 Endpoints Part A (DDI) - Measurement of PK parameters of Dextromethorphan: Cmax
Module 1 Endpoints Part A (DDI) - Measurement of PK parameters of Midazolam: AUC
+13 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: AZD3470 MonotherapyExperimental Treatment1 Intervention
Part A dose escalation and back-fill cohorts and Part B dose optimization and expansion cohorts of varying doses of AZD3470
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
The most common treatments for solid tumors include chemotherapy, immunotherapy, and targeted therapies. Targeted therapies, such as PRMT5 inhibitors like AZD3470, specifically inhibit enzymes or pathways crucial for tumor survival and growth.
For instance, PRMT5 inhibitors block the PRMT5 enzyme, which is essential for the survival of MTAP-deficient tumors, leading to tumor growth inhibition. This precision in targeting specific cancer pathways is particularly important for solid tumor patients as it can result in more effective treatments with fewer side effects compared to traditional chemotherapy, thereby improving patient outcomes.
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,408 Previous Clinical Trials
289,121,855 Total Patients Enrolled
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