AZD4573 + Acalabrutinib for Blood Cancer

Recruiting at 33 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AstraZeneca

Must not be taking: CYP3A inhibitors, Proton-pump inhibitors

Disqualifiers: CNS lymphoma, Severe hepatic impairment, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, AZD4573, combined with another drug, acalabrutinib, for patients with certain blood cancers who haven't responded to other treatments. The drugs work together to kill cancer cells and block their growth. Acalabrutinib is more selective and has fewer side effects compared to an older drug.

Eligibility Criteria

This trial is for adults with advanced blood cancers who have tried at least two prior treatments without a cure in sight. They should not be eligible for curative therapies like CAR-T cell therapy and must have specific types of relapsed/refractory (r/r) blood cancers, such as DLBCL or MZL. Participants need to show active disease requiring treatment, adequate organ and bone marrow function, no recent transfusions or growth factor support, and an ECOG status ≤ 2.

Inclusion Criteria

My blood counts are within normal ranges.

My diagnosis was confirmed through a biopsy and detailed lab tests.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

I have been diagnosed with or currently have progressive multifocal leukoencephalopathy.

You have had a severe allergic or anaphylactic reaction to BH3 mimetics in the past or you are allergic to any of the ingredients in the study treatment.

Serologic status reflecting active hepatitis B or C infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Dose-setting (Module 1, Part A)

Participants receive ascending doses of AZD4573 in combination with acalabrutinib to identify the maximum tolerated dose and/or Recommended Phase II dose (RP2D)

5 weeks

Weekly visits for dose administration

Expansion (Module 1, Part B)

Participants receive the RP2D of AZD4573 in combination with acalabrutinib in separate expansion cohorts

Variable, based on disease progression

Monotherapy and Combination Treatment (Module 2, Part A)

Participants receive AZD4573 monotherapy followed by combination treatment with acalabrutinib

5 weeks for Cycle 1, 3 weeks for subsequent cycles

Weekly visits for dose administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 2.5 years or until disease progression

Treatment Details

Interventions

• Acalabrutinib
• AZD4573

Trial Overview The study tests AZD4573 combined with other anti-cancer agents in patients with advanced blood cancer. It's an open-label Phase I/II trial where the drug is given intravenously. The goal is to find the right dose and see how well it works when paired with different cancer medications.

Participant Groups

Group I: Module 2: Part A and Part B Experimental Treatment 2 Interventions

Participants will receive AZD4573 as monotherapy for Period 1 and AZD4573 + acalabrutinib as combination therapy for Period 2. Part B of Module 2 will be determined from the data emerging from Part A.

Group II: Module 1: Part A and Part B Experimental Treatment 2 Interventions

Participants will receive intravenous ascending doses of AZD4573 once weekly with oral acalabrutinib twice daily continuously in Part A. For Part A, cohorts 1, 2, and 3 have different target dose levels respectively. In Part B, participants will receive the RP2D of AZD4573 from Part A.

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

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland