AZD4573 + Acalabrutinib for Blood Cancer

Recruiting in Palo Alto (17 mi)

+33 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Breakthrough Therapy

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

I am 18 years old or older.

My blood counts are within normal ranges.

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

+18 more

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.

+17 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Group I: Module 2: Part A and Part BExperimental Treatment2 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 BExperimental Treatment2 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.