Clinical Trials /

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

NCT03922204

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of Bispecific Antibody MCLA-145 in Patients With Advanced Solid Tumors
  • 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

Clinical Trial IDs

  • ORG STUDY ID: MCLA-145-CL01/MCLA-145-101
  • SECONDARY ID: 2018-004396-13
  • NCT ID: NCT03922204

Conditions

  • Advanced Cancer
  • Solid Tumor, Adult

Interventions

DrugSynonymsArms
MCLA-145bispecificMCLA-145

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
MCLA-145ExperimentalIn 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
  • MCLA-145

Eligibility 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)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of patients with Dose Limiting Toxicities
Time Frame:first 28 days of treatment
Safety Issue:
Description:

Secondary Outcome Measures

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

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Merus N.V.

Trial Keywords

  • First-in-human
  • MCLA-145
  • Antibodies
  • Bispecific

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