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MCLA-145

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

MCLA-145 · 1 trial · 3 indications

Phase 1 1
NCT03922204A Study of Bispecific Antibody MCLA-145 in Patients With Advanced or Metastatic MalignanciesAdvanced Cancer
COMPLETED72 Analytics
PHASE1COMPLETED
A Study of Bispecific Antibody MCLA-145 in Patients With Advanced or Metastatic Malignancies
Advanced CancerUnlock trial analytics

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 to 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 (matched to "Advanced Cancer")

Frequently asked questions about MCLA-145

What is MCLA-145 used for?

MCLA-145 is an investigational bispecific antibody being studied for the treatment of advanced cancer, including solid tumors and B-cell lymphoma in adults. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does MCLA-145 target?

MCLA-145 is a bispecific antibody designed to engage two distinct targets on immune cells to enhance anti-tumor activity. The specific molecular targets are not disclosed in the available information, but the drug is being evaluated for its ability to treat advanced malignancies.

Who is developing MCLA-145?

MCLA-145 is being developed by Merus N.V., a biopharmaceutical company. Merus is listed on the NASDAQ under the ticker symbol MRUS.

What phase is MCLA-145 in?

MCLA-145 is in Phase 1 clinical development. A Phase 1 study of MCLA-145 in patients with advanced or metastatic malignancies has been completed, and the drug remains investigational.

What clinical trials is MCLA-145 in?

MCLA-145 has been studied in a Phase 1 clinical trial with the identifier NCT03922204, titled 'A Study of Bispecific Antibody MCLA-145 in Patients With Advanced or Metastatic Malignancies.' The trial enrolled 72 participants and was conducted in the United States, Belgium, Netherlands, and Spain.