AZD0305 for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+32 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: AstraZeneca

Disqualifiers: CNS involvement, COPD, Asthma, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests AZD0305, a new drug, in patients with a type of cancer that hasn't responded to multiple treatments. The drug is given through an IV, and researchers will study its effects on the body and the cancer.

Will I have to stop taking my current medications?

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

Research Team

Eligibility Criteria

This trial is for people with Multiple Myeloma who've had at least three prior treatments, including a proteasome inhibitor, an immunomodulator, and an anti-CD38 antibody. They should be relatively active (ECOG 0-1), expected to live at least six more months, and have certain levels of M protein or free light chains indicating disease presence.

Inclusion Criteria

You are expected to live for at least six more months.

My organs and bone marrow are functioning well.

I am fully active or can carry out light work.

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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Phase Ia: Participants receive AZD0305 at escalating doses to evaluate safety and determine the maximum tolerated dose

Duration not specified

Dose Expansion/Optimization

Phase Ib: Participants receive AZD0305 at optimized doses to further evaluate safety, tolerability, and preliminary efficacy

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days post end of treatment

Treatment Details

Interventions

AZD0305 (Other)

Trial OverviewThe study tests AZD0305's safety and effectiveness in those whose multiple myeloma has returned or didn't respond to treatment. It's early-stage research involving multiple centers where participants openly receive the drug while researchers track its effects on their bodies and cancer.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: AZD0305 monotherapyExperimental Treatment1 Intervention

Module 1: Phase Ia: Dose Escalation Phase Ib: Dose Expansion/Optimization AZD0305 will be prescribed at specified dose levels.