A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Intravenously Administered IO-202 and IO-202 + Azacitidine ± Venetoclax in Acute Myeloid Leukemia (AML) Patients With Monocytic Differentiation and in Chronic Myelomonocytic Leukemia (CMML) Patients

Who is this study for? Patients with relapsed/refractory acute myeloid leukemia and chronic myelomonocytic leukemia
What treatments are being studied? IO-202
Status: Completed
Location: See all (14) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients must be ≥18.

• For the Part 1 Dose-Escalation Phase, patients must be diagnosed with the following:

∙ Relapsed or refractory AML with myelomonocytic or monoblastic/monocytic differentiation according to the World Health Organization 2016 criteria and has failed treatment with available therapies known to be active for AML.

‣ Relapsed or refractory CMML and has failed treatment with available therapies known to be active for CMML

• Part 2 Expansion Phase:

∙ Relapsed or refractory LILRB4high AML with myelomonocytic or monoblastic/monocytic differentiation and has failed treatment with available therapies known to be active for AML.

‣ Hypomethylating-agent naive CMML regardless of LILRB4 expression levels.

‣ Newly diagnosed high LILRB4 expression monocytic AML patients considered to be ineligible for standard induction therapy.

• Patients must be amenable to serial BM aspirates/biopsies and peripheral blood sampling during the study.

• Patients must be able to understand and willing to sign an informed consent. A legally authorized representative may consent.

• Patients must have an ECOG performance status of 0 to 2

• Patients must have adequate hepatic function

• Patients must have adequate renal function

• Patients must be recovered from any clinically relevant toxic effects of any prior surgery, radiotherapy, or other therapy intended for the treatment of cancer.

⁃ Patients must be off systemic calcineurin inhibitors for at least 4 weeks prior to study drug treatment.

⁃ Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to the start of therapy.

Locations
United States
California
University California, Davis (117)
Davis
City of Hope (106)
Duarte
University of California, Irvine (107)
Irvine
UCLA, Medical Center Division of Hematology/Oncology (119)
Los Angeles
Stanford University (114)
Palo Alto
University of California, San Francisco (118)
San Francisco
Colorado
University of Colorado, Anschutz Medical Campus (103)
Aurora
Georgia
Winship Cancer Institute of Emory University (105)
Atlanta
Illinois
The University of Chicago (113)
Chicago
New York
Weill Cornell Medical College, New York Presbyterian Hospital (110)
New York
Ohio
Cleveland Clinic, Taussig Cancer Institute (111)
Cleveland
Oregon
Oregon Health and Science University, Center for Hematologic Malignancies (116)
Portland
Texas
University of Texas Southwestern, Simmons Comprehensive Cancer Center (104)
Dallas
MD Anderson Cancer Center (101)
Houston
Time Frame
Start Date: 2020-09-14
Completion Date: 2025-01-31
Participants
Target number of participants: 67
Treatments
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.
Sponsors
Leads: Immune-Onc Therapeutics
Collaborators: California Institute for Regenerative Medicine (CIRM)

This content was sourced from clinicaltrials.gov

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