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MCLA-145

Phase 1

Advanced Cancer | Small molecule | Oncology |Merus N.V.|Last Updated: Dec 11, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03922204A Study of Bispecific Antibody MCLA-145 in Patients With Advanced or Metastatic MalignanciesPHASE1 COMPLETED 72 — — May 8, 2019Nov 7, 2024Dec 11, 20248 United States, Belgium +2
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Study Endpoints
Primary Endpoints
Number of patients with Dose Limiting Toxicities
first 28 days of treatment
Number of patients with Adverse Events and Serious Adverse Events
up to 90 days post-last dose
Secondary Endpoints
Overall response rate (ORR)
Every 8 to 12 weeks until study ends, approximately 4 years
Duration of response ( DOR)
Every 8 to 12 weeks until study ends, approximately 4 years
Disease control rate ( DCR)
Every 8 to 12 weeks until study ends, approximately 4 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MCLA-145EXPERIMENTALIn Part 1, the dose escalation phase, patients with advanced or recurrent/metastatic solid tumors or B-cell lymphomas will receive escalating doses of MCLA-145 (either Q2W for those patients in treatment at the time of Amendment #4 or Q3W with Amendment #4 approval). Treatment will be with MCLA-145 (monotherapy) for Group A, or in combination with pembrolizumab for Group B, 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 either in monotherapy (Group A) or in combination with pembrolizumab (Group B) at the recommended phase II dose every 3 weeks. The duration of each treatment cycle is 21 days
Group B Combination TreatmentEXPERIMENTALPatients in Group B will be treated with MCLA-145 in Combination with pembrolizumab 200mg Q3W.
Interventions
NameTypeDescription
MCLA-145DRUGfull-length IgG1 bispecific antibody specifically targeting PD-L1 and CD137
Pembrolizumab (Keytruda)DRUGGroup B patients will be treated in combination with MCLA-145 and pembrolizumab 200mg Q3W.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Histologically or cytologically confirmed advanced or recurrent/metastatic solid tumors or B-cell lymphomas, that are considered non-amenable to surgery or other curative treatments or procedures (if applicable) * Measureable disease per RECIST v1.1 or Lugano Criteria * Easter...

Countries:United StatesBelgiumNetherlandsSpain
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Competitive Landscape -Cancer 5 trials
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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