AZD0486 for Lymphoma

(Soundtrack-E Trial)

Recruiting at 44 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: AstraZeneca

Must not be taking: CYP3A inhibitors, Vitamin K antagonists

Disqualifiers: CNS lymphoma, Cardiovascular disease, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the safety and efficacy of AZD0486 administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies.

Will I have to stop taking my current medications?

The trial requires that you stop any anticancer therapy at least 21 days before starting the study drug. If you are taking a CYP3A inhibitor or inducer, you may need to stop, especially for certain cohorts. The protocol does not specify other medications, so it's best to discuss with the trial team.

Eligibility Criteria

This trial is for adults with certain types of blood cancers, like lymphoma and leukemia. They should be able to perform daily activities (ECOG 0-2) and use contraception. Specific groups need different prior treatments: one must have had at least two therapies including BTKi and BCL2i; another can join if sensitive to BTKi after one therapy.

Inclusion Criteria

I can care for myself and am up and about more than 50% of my waking hours.

I will use birth control during and for 6 months after treatment.

My lymphocyte count is below 10,000.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive AZD0486 as monotherapy or in combination with other anticancer agents

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 6 years 4 months

Treatment Details

Interventions

• AZD0486 (Monoclonal Antibodies)

Trial Overview The study tests AZD0486 alone or with other cancer drugs (Vincristine, Doxorubicin, Prednisone, Cyclophosphamide, Acalabrutinib, Rituximab) in patients with mature B-cell malignancies. It aims to find out how safe and effective these combinations are against the disease.

Participant Groups

Group I: Substudy 3 (LBCL): AZD0486 + R-CHOP Experimental Treatment 6 Interventions

Participants will receive AZD0486 as intravenous (IV) infusion in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy as per standard of care. For participants achieving CR or PR, AZD0486 will be administered every 3 weeks.

Group II: Substudy 2 (RR MCL): Cohort 2B (AZD0486 + Acalabrutinib) Experimental Treatment 2 Interventions

Participants will receive AZD0486 monotherapy as SC injection. Participants will receive acalabrutinib tablet orally twice daily.

Group III: Substudy 2 (RR MCL): Cohort 2A (AZD0486 Monotherapy) Experimental Treatment 1 Intervention

Participants will receive AZD0486 monotherapy as SC injection.

Group IV: Substudy 1 (RR CLL/SLL): Cohort 1B (AZD0486 + Acalabrutinib) Experimental Treatment 2 Interventions

Participants will receive AZD0486 as SC injection. Participants will receive acalabrutinib tablet orally twice daily.

Group V: Substudy 1 (RR CLL/SLL): Cohort 1A (AZD0486 Monotherapy) Experimental Treatment 1 Intervention

Participants will receive AZD0486 monotherapy as subcutaneous (SC) injection.

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