IO-202 as Monotherapy and IO-202 Plus Azacitidine ± Venetoclax in Patients in AML and CMML

Part of paid clinical trials in Davis, California.

Sponsor
Immune-Onc Therapeutics
Study ID
NCT04372433
Phase
PHASE1
Status
Completed

Conditions

  • AML With Monocytic Differentiation
  • CMML

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IO-202 — BIOLOGICAL
    IO-202 as monotherapy
  • IO-202 and Azacitidine — BIOLOGICAL
    IO-202 and azacitidine combination therapy
  • IO-202 and Azacitidine + Venetoclax — BIOLOGICAL
    IO-202 and azacitidine + venetoclax combination therapy
  • IO-202 and Azacitidine — BIOLOGICAL
    IO-202 and azacitidine combination therapy

Study Details

To assess safety and tolerability at increasing dose levels of IO-202 in successive cohorts of participants with AML with monocytic differentiation and CMML in order to estimate the maximum tolerated dose (MTD) or maximum administered dose (MAD) and select the recommended Phase 2 dose (RP2D)

Key Dates

Start date
Sep 14, 2020
Status verified
Feb 2025
Primary completion
Jan 31, 2025
Completion
Jan 31, 2025

Study Design

Enrollment
67 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation of IO-202
    Dose cohorts treated with intravenous (IV) IO-202 monotherapy in ascending doses.
  • Experimental: Dose Escalation of IO-202 Plus Azacitidine
    AZA Dose cohorts treated with intravenous (IV) IO-202 in ascending doses plus Azacitidine (IV or SC) on days 1-7 of each 28-day cycle.
  • Experimental: Dose Expansion of IO-202 plus Azacitidine AML
    To enroll high LILRB4 expression monocytic AML patients refractory to or relapsed after available therapies known to be active in AML.
  • Experimental: Dose Expansion of IO-202 plus Azacitidine CMML
    To enroll hypomethylating-agent naive CMML patients.
  • Experimental: Dose Expansion of IO-202 plus Azacitidine + Venetoclax (Ven)
    To enroll newly diagnosed high LILRB4 expression AML patients who are unfit for intensive induction chemotherapy.

Primary Outcome Measure

Safety of IO-202 and IO-202 plus azacitidine ± venetoclax as measured by incidence of adverse events. [ Time Frame: From first dose of IO-202 to 30 days following last study treatment ]

Locations (14)

FacilityCityStateZIPSite coordinators
University California, Davis (117)DavisCalifornia95817-
City of Hope (106)DuarteCalifornia91010-
University of California, Irvine (107)IrvineCalifornia92868-
UCLA, Medical Center Division of Hematology/Oncology (119)Los AngelesCalifornia90095-
Stanford University (114)Palo AltoCalifornia94305-
University of California, San Francisco (118)San FranciscoCalifornia94143-
University of Colorado, Anschutz Medical Campus (103)AuroraColorado80045-
Winship Cancer Institute of Emory University (105)AtlantaGeorgia30322-
The University of Chicago (113)ChicagoIllinois60637-
Weill Cornell Medical College, New York Presbyterian Hospital (110)New YorkNew York10021-
Cleveland Clinic, Taussig Cancer Institute (111)ClevelandOhio44195-
Oregon Health and Science University, Center for Hematologic Malignancies (116)PortlandOregon97239-
University of Texas Southwestern, Simmons Comprehensive Cancer Center (104)DallasTexas75390-
MD Anderson Cancer Center (101)HoustonTexas77030-

Find similar trials in Davis, CA

By research site
University California, Davis (117)· Davis, CACity of Hope (106)· Duarte, CAUniversity of California, Irvine (107)· Irvine, CAUCLA, Medical Center Division of Hematology/Oncology (119)· Los Angeles, CAStanford University (114)· Palo Alto, CAUniversity of California, San Francisco (118)· San Francisco, CA

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