Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia

Part of paid clinical trials in Duarte, California.

Sponsor
OncoVerity, Inc.
Study ID
NCT04150887
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Leukemia, Myeloid, Acute

Eligibility Criteria

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

Interventions

  • Cusatuzumab — DRUG
    Cusatuzumab will be administered as a dose of 10mg/kg or 20mg/kg intravenously.
  • Azacitidine — DRUG
    Azacitidine will be administered 75 mg/m\^2 subcutaneously or intravenously.
  • Venetoclax — DRUG
    Venetoclax will be administered orally and the dose will ramp-up to 400 mg.

Study Details

The purpose of the study is to characterize safety and tolerability of cusatuzumab in combination with various therapies used to treat acute myeloid leukemia (AML).

Key Dates

Start date
Dec 23, 2019
Status verified
May 2026
Primary completion
May 15, 2027
Completion
May 15, 2027

Study Design

Enrollment
61 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Cohort 2: Cusatuzumab + Venetoclax
    Participants enrolled in this cohort will receive venetoclax ramp-up to 400 mg orally (as background therapy) starting on Cycle 1 Day 1 and followed by 400 mg daily dosing starting on Cycle 1 Day 4 plus cusatuzumab IV on Day 3 and Day 17 of each 28-day cycle. Cohort 2 will not be enrolled in the US.
  • Experimental: Cohort 3: Cusatuzumab + Venetoclax + Azacitidine (CVA)
    Participants enrolled at US sites will receive cusatuzumab 10 mg/kg and potentially escalate to 20 mg/kg IV in combination with azacitidine 75 mg/m\^2 SC or IV plus venetoclax ramp-up to 400 mg orally (as background therapies). Participants enrolled from ex-US sites will receive cusatuzumab 20 mg/kg and potentially de-escalate to 10 mg/kg IV in combination with azacitidine 75 mg/m\^2 SC or IV plus venetoclax ramp-up to 400 mg orally (as background therapies).

Primary Outcome Measure

Frequency and Severity of Adverse Events (AEs), Laboratory Abnormalities, and Physical Exam Findings as a Measure of Safety [ Time Frame: Up to 42 months ]

Locations (11)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Norton Cancer InstituteLouisvilleKentucky40207-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
Roswell Park Cancer InstituteBuffaloNew York14203-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Weill Cornell MedicineNew YorkNew York10021-
University of RochesterRochesterNew York14642-
University of Pittsburgh School of MedicinePittsburghPennsylvania15232-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
University of VermontBurlingtonVermont05401-
Wisconsin Medical CenterMilwaukeeWisconsin53226-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CANorton Cancer Institute· Louisville, KYBarbara Ann Karmanos Cancer Institute· Detroit, MIRoswell Park Cancer Institute· Buffalo, NYMemorial Sloan Kettering Cancer Center· New York, NYWeill Cornell Medicine· New York, NY

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