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A Study of AC676 for the Treatment of Relapsed/Refractory B-Cell Malignancies

ConditionRelapsed/Refractory B-cell Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAccutar Biotechnology Inc

About this trial

This clinical trial is evaluating a drug called AC676 in participants with Relapsed/Refractory B-cell Malignancies. The main goals of the study are to:

* Identify the recommended dose of AC676 that can be given safely to participants * Evaluate the safety profile of AC676 * Evaluate the pharmacokinetics of AC676 * Evaluate the effectiveness of AC676

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult male and female patients, at least 18 years-of-age at the time of signature of the informed consent form (ICF).

Patients with histologically confirmed relapsed/refractory Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Mantle Cell Lymphoma (MCL), Follicular Lymphoma (FL), non-GCB Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL), or Waldenström Macroglobulinemia (WM).

Must have received at least 2 prior systemic therapies or have no other therapies to provide significant clinical benefit in the opinion of the Investigator or who are not amenable (intolerability, patient choice) to standard therapies.

Disqualifiers

Small molecule anti-cancer drugs within 5 half-lives or 2 days (whichever is longer, not to exceed 14 days).

Systemic chemotherapy within 14 days.

Radiation therapy within 14 days

Biologics (Antibodies) treatment within 28 days,

Trial design

Design model

Sequential

Treatments tested in this trial

  • AC676

    Drug

    AC676 will be given orally (PO) on a 28-day cycle.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: AC676 Dose EscalationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of dose limiting toxicities (DLTs) from AC676 monotherapy

Time frame
From cycle 1 day 1 to Cycle 1 day 28. Cycles are 28 days.
2

Incidence of treatment-emergent adverse events (TEAEs) and clinically significant Grade 3 or higher laboratory abnormalities using CTCAE v5.0 criteria.

Time frame
Approximately 18 months
3

Maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D)

Time frame
Approximately 18 months

Secondary outcomes

1

Pharmacokinetic Analysis: area under the plasma concentration-time curve over the dosing interval (AUC(0-inf))

Time frame
Up to approximately 20 weeks
2

Pharmacokinetic Analysis: area under the plasma concentration-time curve from over the dosing interval (AUC(0-tau))

Time frame
Up to approximately 20 weeks
3

Pharmacokinetic Analysis: maximum plasma concentration (Cmax)

Time frame
Up to approximately 20 weeks
4

Pharmacokinetic Analysis: time to maximum plasma concentration (tmax)

Time frame
Up to approximately 20 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Accutar Biotechnology Inc

Lead sponsor

Source ClinicalTrials.gov
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