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A Study of Bispecific Antibody MCLA-145 in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03922204
Recruitment Status : Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Merus N.V.

Brief Summary:
This is a Phase 1, open label, non-randomised, dose-escalation single agent study with expansion cohorts for dose confirmation/safety and preliminary efficacy of MCLA-145 in selected advanced or metastatic solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Cancer Solid Tumor, Adult Drug: MCLA-145 Phase 1

Detailed Description:

Study Design: This open label, multicenter, first in human study consists of 2 parts. Part 1 is a dose escalation to find the recommended dose for the expansion.

Part 2 is a dose expansion to confirm the dose of MCLA-145 through further evaluation of safety, tolerability, Pk, preliminary antitumor activity, and functional target engagement.

The study includes three periods: Screening( up to 28 days prior to the first dose of study drug); Treatment( first dose of study drug with treatment cycles of 28 days); and Follow-up ( 30 days and 90 days after the last dose) including survival follow-up checks every 2 months up to 12 months after the last dose.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose-Escalation, Safety, Tolerability, and Preliminary Efficacy Study of MCLA-145 in Participants With Select Advanced or Metastatic Solid Tumors
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: MCLA-145
In Part 1, the dose escalation phase, patients with advanced or recurrent/metastatic solid tumors will receive escalating doses of MCLA-145 ( every 2 weeks ) until MTD or RDE is reached. In Part 2, the expansion phase, participants with advanced or metastatic solid tumors will receive intravenous infusion of MCLA-145 at the recommended phase II dose every 2 weeks. The duration of each treatment cycle is 28 days
Drug: MCLA-145
full-length IgG1 bispecific antibody specifically targeting PD-L1 and CD137
Other Name: bispecific




Primary Outcome Measures :
  1. Number of patients with Dose Limiting Toxicities [ Time Frame: first 28 days of treatment ]
  2. Number of patients with Adverse Events and Serious Adverse Events [ Time Frame: up to 90 days post-last dose ]

Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: Every 8 to 12 weeks until study ends, approximately 4 years ]
  2. Duration of response ( DOR) [ Time Frame: Every 8 to 12 weeks until study ends, approximately 4 years ]
  3. Disease control rate ( DCR) [ Time Frame: Every 8 to 12 weeks until study ends, approximately 4 years ]
  4. Progression Free Survival ( PFS) [ Time Frame: Every 8 to 12 weeks until study ends, approximately 4 years ]
  5. Incidence of anti-drug antibodies against MCLA-145 [ Time Frame: 12 months ]
  6. Peak plasma concentration [Cmax] [ Time Frame: 12 months ]
  7. Area under the plasma concentration versus time curve [AUC] [ Time Frame: 12 months ]
  8. Half-life [t1/2] [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed advanced or recurrent/metastatic solid tumors that are considered non-amenable to surgery or other curative treatments or procedures (if applicable)
  • Measureable disease per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Received prior standard therapy for advanced or recurrent/metastatic disease as applicable to tumor type
  • Received a maximum of 4 prior systemic treatment regimens (inclusive of chemotherapy, immunotherapy, and targeted therapy regimens) for advanced or recurrent/metastatic disease
  • Life expectancy of ≥12 weeks, as per investigator judgement

Exclusion Criteria:

  • Prior therapy containing an anti-PD-L1 agent or T-cell agonist
  • Current serious illness or medical condition including, but not limited to uncontrolled active infection
  • Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting MCLA-145
  • Prior ≥ Grade 3 immune-mediated AEs with anti-PD-1 therapy
  • History of any grade immune-mediated ocular AEs.
  • Known hypersensitivity or severe reaction to any component of MCLA-145 or formulation components
  • Participants who have active or inactive autoimmune disease or syndrome (eg, rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease) that has required systemic treatment in the past 2 years or who are receiving systemic therapy for an autoimmune or inflammatory disease (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922204


Contacts
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Contact: Ernesto Wasserman, MD +31302538800 enquires@merus.nl
Contact: Andres Sirulnik, MD, Ph.D +31302538800 enquires@merus.nl

Locations
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United States, Massachusetts
Dana-Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Stephen Hodi, MD         
Principal Investigator: Stephen Hodi, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
Contact: Chrisann Kyi, MD         
Principal Investigator: Chrisann Kyi, MD         
Sponsors and Collaborators
Merus N.V.
Incyte Corporation
Investigators
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Study Director: Ernesto Wasserman, MD Merus N.V.

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Responsible Party: Merus N.V.
ClinicalTrials.gov Identifier: NCT03922204     History of Changes
Other Study ID Numbers: MCLA-145-CL01/MCLA-145-101
2018-004396-13 ( EudraCT Number )
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Merus N.V.:
First-in-human
MCLA-145
Antibodies
Bispecific

Additional relevant MeSH terms:
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Antibodies
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs