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

Sponsor
Accutar Biotechnology Inc (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05780034
Collaborator
(none)
60
1
32

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

AC676-001 is a Phase I, first-in-human, open-label, multi-center dose-escalation study of AC676 given as a single agent. AC676 is an investigational medicinal product that is an orally bioavailable BTK degrader for the treatment of B-cell malignancies.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Malignancy Activity of AC676 in Patients With Relapsed/Refractory B-cell Malignancies
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: AC676 Dose Escalation

Participants will receive an assigned dose of AC676 in a 28-days cycle.

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of dose limiting toxicities (DLTs) from AC676 monotherapy [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. [Approximately 18 months]

  3. Maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) [Approximately 18 months]

Secondary Outcome Measures

  1. Pharmacokinetic Analysis: area under the plasma concentration-time curve over the dosing interval (AUC(0-inf)) [Up to approximately 20 weeks]

  2. Pharmacokinetic Analysis: area under the plasma concentration-time curve from over the dosing interval (AUC(0-tau)) [Up to approximately 20 weeks]

  3. Pharmacokinetic Analysis: maximum plasma concentration (Cmax) [Up to approximately 20 weeks]

  4. Pharmacokinetic Analysis: time to maximum plasma concentration (tmax) [Up to approximately 20 weeks]

  5. Pharmacokinetic Analysis: terminal elimination half-life (t1/2) [Up to approximately 20 weeks]

  6. Objective Response Rate (ORR) in patients receiving AC676 [Approximately 18 months]

  7. Duration of Response (DOR) in patients receiving AC676 [Approximately 18 months]

  8. Time to Response (TTR) in patients receiving AC676 [Approximately 18 months]

  9. Disease Control Rate (DCR) in patients receiving AC676 [Approximately 18 months]

  10. Progression Free Survival rate (PFS) in patients receiving AC676 [Approximately 18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Adult male and female patients, at least 18 years-of-age at the time of signature of the informed consent form (ICF).

  2. 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).

  3. 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.

Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from study entry:
  1. Treatment with any of the following:
  • 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,

  • Radioimmunoconjugates or toxin conjugates within 12 weeks.

  • Prior Chimeric antigen receptor (CAR) T cell therapy (and prior use of immunoglobulin replacement therapy to treat associated adverse events) within 3 months. For patients with DLBCL, no prior CAR- T therapy is allowed.

  • Autologous or allogenic stem cell transplant within 100 days. Any patient who experienced graft versus host disease during a prior allogenic stem cell transplant will not be allowed on study.

  1. History of central nervous system lymphoma/leukemia in remission for less than 2 years.

  2. Medical history of active bleeding within 2 months prior to study entry, or susceptible to bleeding by the judgement of investigator.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Accutar Biotechnology Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Accutar Biotechnology Inc
ClinicalTrials.gov Identifier:
NCT05780034
Other Study ID Numbers:
  • AC676-001
First Posted:
Mar 22, 2023
Last Update Posted:
Mar 28, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Accutar Biotechnology Inc
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 28, 2023