AZD3470 for Advanced Solid Cancers

(PRIMROSE Trial)

Recruiting at 19 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AstraZeneca

Must not be taking: Anticoagulants, PRMT5 inhibitors

Disqualifiers: Brain metastases, Cardiovascular disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

234 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AZD3470 for individuals with advanced solid tumors lacking a specific protein (MTAP deficiency). The main goal is to determine if AZD3470 is safe and effective, either alone or with other cancer treatments. This study may suit those who have tried other cancer treatments without success and have a tumor with the MTAP deficiency. Participants must be willing to provide a tumor sample for testing and have a measurable tumor. As a Phase 1, Phase 2 trial, this research aims to understand how AZD3470 works in people and measure its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking cancer treatment development.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that AZD3470 is likely to be safe for humans?

Research has shown that AZD3470 is a new treatment undergoing its first human tests. As it is in the early testing stages, limited information exists about its safety. The primary aim of these initial studies is to determine the safety and tolerability of AZD3470 for individuals with advanced solid cancers.

Researchers will closely monitor side effects to assess how well participants tolerate the treatment. AZD3470 acts as a PRMT5 inhibitor, targeting specific cancer cells. While this approach shows promise, its safety remains under study due to the treatment's early stage. Researchers carefully monitor participants to ensure their well-being throughout the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about AZD3470 for advanced solid cancers because it introduces a novel approach by targeting specific cellular pathways that current treatments may not address. Unlike standard treatments, which often include chemotherapy or targeted therapies that act broadly, AZD3470 focuses on unique molecular mechanisms within cancer cells, potentially offering a more precise method of attack. This targeted action may lead to fewer side effects and improved effectiveness, providing hope for better outcomes in patients with advanced stages of solid tumors.

What evidence suggests that AZD3470 might be an effective treatment for advanced solid cancers?

Research has shown that AZD3470 targets an enzyme called PRMT5, which aids cancer cell growth. This enzyme is particularly active in tumors lacking a substance called MTAP, a condition common in several advanced solid cancers. Early lab studies suggest that AZD3470 might slow or stop tumor growth by blocking PRMT5. Although limited data exist from human studies, the drug's mechanism suggests it could be effective for these cancers. This trial examines how well AZD3470 is absorbed, its effects on the body, and its initial effectiveness in participants receiving AZD3470 monotherapy. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

The doctor believes you will live for at least 12 weeks.

You need to use birth control as required by local rules for participating in the study.

Participants must have at least one specific, measurable abnormality in their tumor according to certain guidelines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive varying doses of AZD3470 to determine the optimal dose

4 weeks

Multiple visits for dose adjustments and monitoring

Dose Optimization and Expansion

Participants receive optimized doses of AZD3470 to evaluate safety and efficacy

12 weeks

Regular visits for safety and efficacy assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term Follow-up

Participants are monitored for overall survival and progression-free survival

Approximately 2 years

What Are the Treatments Tested in This Trial?

Interventions

• AZD3470

Trial Overview

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.

How Is the Trial Designed?

Group I: AZD3470 Monotherapy Experimental Treatment 1 Intervention

Part A dose escalation and back-fill cohorts and Part B dose optimization and expansion cohorts of varying doses of AZD3470

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Citations

1.

astrazenecaclinicaltrials.com

astrazenecaclinicaltrials.com/study/D9970C00001

A study of AZD3470, a PRMT5 inhibitor, in patients with ...

This is a first time in human (FTiH) Phase I/IIa, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumors with MTAP

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06130553

NCT06130553 | A Study of AZD3470, a PRMT5 Inhibitor, in ...

This is a first time in human (FTiH) Phase I/IIa, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumors with MTAP ...

3.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS3179

PRIMROSE: A modular phase 1/2a study of AZD3470, an ...

PRIMROSE: A modular phase 1/2a study of AZD3470, an MTA-cooperative PRMT5 inhibitor, in patients with MTAP deficient advanced solid tumors.

4.

clinicaltrials.eu

clinicaltrials.eu/inn/azd3470/

AZD3470: A Promising New Drug for Cancer Treatment

AZD3470 is a novel drug currently being studied in clinical trials for its potential in treating advanced solid tumors and hematologic malignancies.

5.

rarecancers.org.au

rarecancers.org.au/knowledgebase/clinical-trials/a-study-of-azd3470-a-prmt5-inhibitor-in-patients-with-mtap-deficient-advanced-metastatic-solid-tumors-primrose/

A Study of AZD3470, a PRMT5 Inhibitor, in Patients With ...

The study consists of several study modules, evaluating the safety, tolerability, pharmacokinetic (PK), pharmacodynamics, and preliminary efficacy of AZD3470 as ...

6.

cancer.gov

cancer.gov/research/participate/clinical-trials/intervention/prmt5-inhibitor-azd3470?pn=1

Clinical Trials Using PRMT5 Inhibitor AZD3470 - NCI

Trials 1-2 of 2. A Study of AZD3470, a PRMT5 Inhibitor, in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors. Status: Active. Location: 6 locations.

7.

clinicaltrials.ucsf.edu

clinicaltrials.ucsf.edu/trial/NCT06130553

AZD3470, a PRMT5 Inhibitor, in Patients With MTAP Deficient ...

This is a first time in human (FTiH) Phase I/IIa, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumors with MTAP ...