Acalabrutinib + ACP-319 for B-cell Cancers

Recruiting in Palo Alto (17 mi)

+8 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Acerta Pharma BV

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy acalabrutinib and ACP 319 in B-cell malignancies.

Eligibility Criteria

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.

Inclusion Criteria

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

Agreement to use contraception during the study and for 90 days after the last dose of study drugs if sexually active and able to bear or beget children

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

Exclusion Criteria

I haven't taken any therapeutic antibodies in the last 4 weeks.

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

I have waited less than 5 half-lives of my last cancer treatment before starting a new one.

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Treatment Details

Interventions

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)
ACP-319 (Other)

Trial OverviewThe 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.

Participant Groups

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.

Acalabrutinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Calquence for: