A Study of CG-806 in Patients With Relapsed or Refractory CLL/SLL or Non-Hodgkin's Lymphomas

A Phase Ia/b Trial to Evaluate the Safety and Tolerability of CG-806 in Patients With CLL/SLL or Non-Hodgkin's Lymphomas

This study is being done to evaluate the safety, tolerability and effectiveness of Oral CG-806 for the treatment of patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or Non-Hodgkin's Lymphomas who have failed or are intolerant to two or more lines of established therapy or for whom no other treatment options are available.

Study Overview

• Status: Terminated
• Conditions: Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
• Intervention / Treatment: Drug: CG-806

Detailed Description

This is a multicenter, open-label, Phase Ia/b dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the MTD or recommended dose in patients with relapsed or refractory CLL/SLL or Non-Hodgkin's Lymphoma patients. This is to be followed by a cohort expansion phase at the MTD or recommended oral dose.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles
    • Monterey, California, United States, 93940
      • Pacific Cancer Care
    • Redondo Beach, California, United States, 90277
      • Torrance Memorial Physician Network
    • San Diego, California, United States, 92123
      • Sharp Clinical Oncology Research
    • San Diego, California, United States, 92093
      • UCSD Moores Cancer Center
    • Santa Barbara, California, United States, 93105
      • Ridley-Tree Cancer Center
    • Santa Rosa, California, United States, 95403
      • St. Joseph Heritage Heathcare
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Cancer Centers
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville
    • Orlando, Florida, United States, 32806
      • Orlando Health
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Medical Oncology and Hematology
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Greenebaum Comprehensive Cancer Center
    • Bethesda, Maryland, United States, 20817
      • The Center for Cancer and Blood Disorders a division of American Oncology Partners of Maryland, PA
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester
  • Montana
    • Billings, Montana, United States, 59102
      • SCL Health, St. Vincent Frontier Cancer Center
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10016
      • Manhattan Hematology Oncology
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health - ITOR
    • Rock Hill, South Carolina, United States, 29732
      • Carolina Blood and Cancer Care Associates
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Oncology - Austin-Midtown
    • Dallas, Texas, United States, 75246
      • Texas Oncology - Baylor Charles A. Sammons Cancer Center
    • Fort Worth, Texas, United States, 76104
      • Texas Oncology - Fort Worth Cancer Center
    • Houston, Texas, United States, 77030
      • University of Texas, M.D. Anderson Cancer Center
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio, Mays Cancer Center
    • Tyler, Texas, United States, 75702
      • Texas Oncology - Tyler
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
  • Washington
    • Vancouver, Washington, United States, 98684
      • Northwest Cancer Specialists, P.C. - Compass Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years
• Life expectancy of at least 2 months
• ECOG Performance Status ≤ 2
• Patients must be able to swallow capsules
• Adequate hematologic parameters, unless cytopenias are disease caused
• Adequate renal, liver and cardiac function parameters

Exclusion Criteria:

• Patients with GVHD requiring systemic immunosuppressive therapy
• Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinical significant disease related metabolic disorder
• Clinically significant intravascular coagulation
• Treatment with other investigational drugs within 14 days prior to first study treatment administration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation and Expansion; CG-806 will be given orally in ascending doses in patients with relapsed or refractory CLL/SLL or Non-Hodgkin's Lymphomas (escalation cohort), until the maximum tolerated dose or recommended dose is reached. Followed by up to 100 patients enrolled in the expansion cohort at the recommended dose.	Drug: CG-806; CG-806 will be given orally in ascending doses starting at 150 mg PO BID until the maximum tolerated dose or recommended dose is reached.; Other Names: Luxeptinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events of CG-806	To determine the safety and tolerability of CG-806.	Cycle 1 (28 days)
Establish a CG-806 dose that maintains a biologically active plasma concentration	To determine the dose of CG-806 given orally every 12 hours that maintains a biologically active plasma concentration over a period of 28 days.	Cycle 1 (28 days)
Establish recommended dose for future development of CG-806	To establish the recommended Phase 2 dose (RP2D) of CG-806 for future clinical trials in patients with advanced CLL/SLL or NHL.	Up to 10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic variables including maximum plasma concentration (Cmax)	Pharmacokinetic variables including maximum plasma concentration (Cmax)	Cycle 1 (28 days)
Pharmacokinetic variables including minimum plasma concentration (Cmin)	Pharmacokinetic variables including minimum plasma concentration (Cmin)	Cycle 1 (28 days)
Pharmacokinetic variables including volume of distribution	Pharmacokinetic variables including volume of distribution	Cycle 1 (28 days)
Pharmacokinetic variables including clearance	Pharmacokinetic variables including clearance	Cycle 1 (28 days)
Pharmacokinetic variables including serum half-life	Pharmacokinetic variables including serum half-life	Cycle 1 (28 days)
Pharmacokinetic variables including Area Under the Curve (AUC) Pharmacokinetic variables including Area Under the Curve (AUC Pharmacokinetic variables including Area Under the Curve (AUC	Pharmacokinetic variables including Area Under the Curve (AUC)	Cycle 1 (28 days)
To assess the antitumor activity of CG-806 using FDG PET-CT imaging evaluations	To assess the antitumor activity of CG-806 using FDG PET-CT imaging evaluations	Average 2 Cycles (8 weeks)
Pharmacodynamic biomarkers of drug effect including BTK activity	Pharmacodynamic biomarkers of drug effect including BTK activity	Average 2 cycles (8 weeks)
Pharmacodynamic biomarkers of drug effect including selected mRNA levels	Pharmacodynamic biomarkers of drug effect including selected mRNA levels	Average 2 cycles (8 weeks)
To assess the relative BA of formulation G1 against formulation G2	To assess the relative bioavailability of original formulation (G1) against new generation formulation (G2).	Cycle 1 (28 days)
To assess the relative BA of formulation G1 against formulation G3	To assess the relative bioavailability of original formulation (G1) against new generation formulation (G3).	Cycle 1 Lead-Up (3 days)

Collaborators and Investigators

• Sponsor: Aptose Biosciences Inc.
• Investigators: Study Director: Rafael Bejar, MD, PhD, Aptose Biosciences Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2019
• Primary Completion (Actual): May 17, 2024
• Study Completion (Actual): May 17, 2024

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: DLBCL; Oral; FL; MCL; MZL; CLL; SLL; WM; LPL; PMBCL; BCLU; GZL
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: APTO-CG-806-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No