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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03922204
Recruitment Status : Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Incyte Corporation
Information provided by (Responsible Party):
Merus N.V.

Tracking Information
First Submitted Date  ICMJE April 15, 2019
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date April 19, 2019
Estimated Study Start Date  ICMJE June 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • Number of patients with Dose Limiting Toxicities [ Time Frame: first 28 days of treatment ]
  • Number of patients with Adverse Events and Serious Adverse Events [ Time Frame: up to 90 days post-last dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • Overall response rate (ORR) [ Time Frame: Every 8 to 12 weeks until study ends, approximately 4 years ]
  • Duration of response ( DOR) [ Time Frame: Every 8 to 12 weeks until study ends, approximately 4 years ]
  • Disease control rate ( DCR) [ Time Frame: Every 8 to 12 weeks until study ends, approximately 4 years ]
  • Progression Free Survival ( PFS) [ Time Frame: Every 8 to 12 weeks until study ends, approximately 4 years ]
  • Incidence of anti-drug antibodies against MCLA-145 [ Time Frame: 12 months ]
  • Peak plasma concentration [Cmax] [ Time Frame: 12 months ]
  • Area under the plasma concentration versus time curve [AUC] [ Time Frame: 12 months ]
  • Half-life [t1/2] [ Time Frame: 12 months ]
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 A Study of Bispecific Antibody MCLA-145 in Patients With Advanced Solid Tumors
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Cancer
  • Solid Tumor, Adult
Intervention  ICMJE Drug: MCLA-145
full-length IgG1 bispecific antibody specifically targeting PD-L1 and CD137
Other Name: bispecific
Study Arms  ICMJE 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
Intervention: Drug: MCLA-145
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 18, 2019)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ernesto Wasserman, MD +31302538800
Contact: Andres Sirulnik, MD, Ph.D +31302538800
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03922204
Other Study ID Numbers  ICMJE MCLA-145-CL01/MCLA-145-101
2018-004396-13 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Merus N.V.
Study Sponsor  ICMJE Merus N.V.
Collaborators  ICMJE Incyte Corporation
Investigators  ICMJE
Study Director: Ernesto Wasserman, MD Merus N.V.
PRS Account Merus N.V.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP