MCLA-117 in Acute Myelogenous Leukemia
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ClinicalTrials.gov Identifier: NCT03038230 |
Recruitment Status : Unknown
Verified August 2018 by Merus N.V..
Recruitment status was: Recruiting
First Posted : January 31, 2017
Last Update Posted : August 14, 2018
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Tracking Information | |||||
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First Submitted Date ICMJE | January 26, 2017 | ||||
First Posted Date ICMJE | January 31, 2017 | ||||
Last Update Posted Date | August 14, 2018 | ||||
Study Start Date ICMJE | April 2016 | ||||
Estimated Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of participants with Dose Limiting Toxicities (DLT) [ Time Frame: 28 days ] Evaluation of number of participants with treatment related toxicity observed during a dose escalation step for 1 Cycle
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | MCLA-117 in Acute Myelogenous Leukemia | ||||
Official Title ICMJE | A Phase 1, Multinational Study of MCLA-117 in Acute Myelogenous Leukemia | ||||
Brief Summary | This is a First-in-Human, single arm, open-label, multi-national study designed to determine the safety, tolerability and preliminary efficacy of MCLA 117. | ||||
Detailed Description | Study Design : This open label, single arm, multinational, first-in-human study consists of 2 parts. Part 1 consists of dose escalation cohorts and Part 2 is a dose expansion cohort. The study population will include adult AML patients (and all subtypes of AML) with relapse or refractory disease and newly diagnosed elderly untreated AML patients with high risk cytogenetics. In Part 1, dose escalations cohorts are followed until dose-limiting toxicity (DLT) or a maximum tolerated dose (MTD) or RecommendedPart2Dose (RP2D) is defined. Dose escalation decisions will be made by the Data Review Committee and will be primarily guided by safety data observed through the end of Cycle 1, as well as on-going assessment of safety beyond Cycle 1 in later cohorts. Part 2 will begin once the MTD or RP2D is determined in Part 1. Part 2 will further characterize the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), immunogenicity and to assess preliminary efficacy of MCLA-117. This part will enroll at least 15 evaluable patients (defined as evaluable for first efficacy assessment). For both parts, the study consists of 3 periods: a Screening period (up to 28 days prior to the first dose of study drug); a Treatment period (first dose of study drug until the last dose of study drug with treatment cycles of 28 days); and a Follow Up period (through 30 days after the last dose and quarterly checks for survival data for up to 1 year). Participants' safety will be monitored throughout the study. Patients will be permitted to receive MCLA-117 beyond Cycle 1 if conditions allow this. Number of Sites: Approximately 8 centers in five countries are estimated to be involved during Parts 1 and 2 of the study. Additional sites may be added to ensure there is an acceptable enrollment rate or to replace non-enrolling/withdrawn sites. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: MCLA-117 bispecific antibody
MCLA-117, a human bispecific IgG antibody which targets CLEC12A and CD3
Other Names:
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Study Arms ICMJE | Experimental: MCLA-117 bispecific antibody
Dose escalation cohorts, with escalating doses of MCLA-117 until MTD or RP2D is reached. The dose is given weekly after initial ramp-up dosing steps. Each Cycle is 28 days. Single agent treatment. Part 2-Expansion Cohort: The RP2D of MCLA-117 is given weekly after initial ramp-up dosing steps. Each Cycle is 28 days. Single agent treatment. Intervention: Drug: MCLA-117 bispecific antibody
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
50 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2018 | ||||
Estimated Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Belgium, France, Italy, Netherlands, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03038230 | ||||
Other Study ID Numbers ICMJE | MCLA-117-CL01 2015-003704-23 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | Merus N.V. | ||||
Study Sponsor ICMJE | Merus N.V. | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Merus N.V. | ||||
Verification Date | August 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |