226 Participants Needed

AZD0305 for Multiple Myeloma

Recruiting at 36 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: AstraZeneca
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AZD0305 for individuals with multiple myeloma, a type of blood cancer that has returned or did not respond to previous treatments. The trial aims to assess the safety and effectiveness of AZD0305 and determine the optimal dose for patients. It is suitable for those who have tried at least three other treatments, including specific cancer drugs, and whose disease can be measured through blood or urine tests. Individuals with asthma, certain heart conditions, or nerve problems might not qualify. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that AZD0305 is likely to be safe for humans?

Research shows that AZD0305 is being tested as a new treatment for relapsed or refractory multiple myeloma, a type of blood cancer. Studies have focused on the safety and tolerability of AZD0305 for patients. Although detailed safety data is not yet available, the treatment is in the early testing stages (Phase 1/2).

The main goal is to assess patient tolerance and identify potential side effects. Early trials typically start with small doses, gradually increasing to find the safest effective dose. AZD0305's progression to this phase indicates it has shown sufficient safety for further testing. While initial findings suggest it is safe enough for broader testing, side effects may still occur, and interested individuals should consult their doctor.12345

Why do researchers think this study treatment might be promising for multiple myeloma?

AZD0305 is unique because it offers a new approach to treating multiple myeloma by targeting specific pathways that current standard treatments, like proteasome inhibitors and immunomodulatory drugs, do not. Most treatments for multiple myeloma focus on either stopping cancer cells from growing or boosting the immune system to fight off cancer. AZD0305, however, is designed to optimize the dosage for maximum effectiveness while minimizing side effects. Researchers are excited about its potential to provide a more targeted and possibly more effective treatment option, which could lead to better outcomes for patients.

What evidence suggests that AZD0305 might be an effective treatment for multiple myeloma?

Research has shown that AZD0305 holds promise in early lab studies for treating multiple myeloma, particularly in patients whose cancer has returned or continued to grow despite other treatments. In this trial, participants will receive AZD0305 as a monotherapy. These studies suggest that AZD0305, a new type of antibody-based drug, could be effective for patients who have no other options or cannot tolerate existing treatments. The drug targets specific proteins on cancer cells, potentially leading to their destruction. While research in humans is ongoing, early results are encouraging and suggest that AZD0305 could help manage this challenging condition.12346

Are You a Good Fit for This Trial?

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.
See 2 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • AZD0305
Trial Overview The 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: AZD0305 monotherapyExperimental Treatment1 Intervention

Find a Clinic Near You

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

Study Details | NCT06106945 | AZD0305 as Monotherapy ...This study will follow a modular protocol design evaluating AZD0305 as monotherapy and in combination with other anticancer agents. The study includes dose ...
AZD0305 as Monotherapy or in Combination With ...This study will follow a modular protocol design evaluating AZD0305 as monotherapy and in combination with other anticancer agents.
Azd0305 – Application in Therapy and Current Clinical ...AZD0305 is a new drug being tested for relapsed or refractory multiple myeloma. It's being studied in a clinical trial to see how safe and effective it is, both ...
A Phase I/II Study of AZD0305, a Novel Antibody-Drug ...AZD0305 has shown preclinical activity against MM and has the potential to be active in patients with RRMM who have exhausted or cannot tolerate ...
A Phase 1/2 Study of AZD0305 to Treat Multiple MyelomaThe people in this study have multiple myeloma that came back or keeps growing after treatment. AZD0305 is given intravenously (by vein). Who Can Join. To join ...
AZD0305 as Monotherapy or in Combination ...Summary/Purpose: This is a Phase I/II, modular, open-label, multicenter, dose escalation, and dose expansion/optimization study to evaluate the safety, ...
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