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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + ACP-319 for B-cell Cancers

Phase 1 & 2

Waitlist Available

Research Sponsored by Acerta Pharma BV

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Diagnosis of a b-cell malignancy as documented by medical records and with histology based on criteria established by the World Health Organization (WHO)

Must not have

Central nervous system (CNS) involvement by lymphoma/leukemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of the treatment to the last evaluable disease assessment, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug for safety, how it is processed by the body, and how well it works against B-cell cancers.

Who is the study for?

This trial is for people with B-cell malignancies like multiple myeloma or non-Hodgkin's lymphoma. Participants should be relatively active (ECOG ≤ 2), willing to use contraception, and have no major illnesses that could risk their safety or the study results. They shouldn't have had recent chemotherapy, extremely low blood cell counts not due to bone marrow disease, severe kidney or liver issues, CNS involvement by cancer, or any therapeutic antibodies in the last month.

What is being tested?

The trial tests Acalabrutinib combined with ACP-319 on patients with B-cell cancers. It aims to assess how safe these drugs are together, how they affect the body (pharmacodynamics), how the body processes them (pharmacokinetics), and their effectiveness against these cancers.

What are the potential side effects?

Potential side effects of Acalabrutinib and ACP-319 may include digestive problems, headaches, high blood pressure, minor bleeding issues like bruising easily due to lower platelets count in your blood and some infections because of a weakened immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of the day.

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My diagnosis is a B-cell cancer, confirmed by medical records and WHO criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lymphoma/leukemia has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of the treatment to the last evaluable disease assessment, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of the treatment to the last evaluable disease assessment, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of the treatment to the last evaluable disease assessment, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best Response and Overall Response Rate

Secondary study objectives

Plasma

Evaluate Efficacy Activity of acalabrutinib and ACP-319 as measured by duration of response

Evaluate Efficacy Activity of acalabrutinib and ACP-319 as measured by progression-free survival

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation and ExpansionExperimental Treatment2 Interventions

The acalabrutinib dose will be fixed and the ACP-319 dose will be escalated in each of three cohorts, and each cohort will take both study drugs by mouth, twice per day (BID) at approximately 12 hour intervals. Expansion groups of up to 12 subjects for Germinal center B-cell (GCB) DLBCL and Non-GCB DLBCL to take a fixed dose of acalabrutinib and ACP-319. Each disease group will take both study drugs by mouth, twice per day (BID) at approximately 12 hour intervals.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acalabrutinib

2020

Completed Phase 2

~2080

0 / 3Eligibility criteria met