AZD3470 for Advanced Solid Cancers

(PRIMROSE Trial)

Recruiting at 17 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: AstraZeneca

Must not be taking: Anticoagulants, PRMT5 inhibitors

Disqualifiers: Brain metastases, Cardiovascular disease, HIV, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• AZD3470 (PRMT5 Inhibitor)

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.

Participant Groups

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