The trial is taking place at:
C

Clinica Universidad de Navarra | Sede Madrid - Hematology Department

Veeva-enabled site

A Study of Bispecific Antibody MCLA-145 in Patients With Advanced or Metastatic Malignancies

M

Merus

Status and phase

Enrolling
Phase 1

Conditions

Advanced Cancer
Solid Tumor, Adult
B-cell Lymphoma, Adult

Treatments

Drug: MCLA-145

Study type

Interventional

Funder types

Industry

Identifiers

NCT03922204
MCLA-145-CL01/MCLA-145-101
2018-004396-13 (EudraCT Number)

Details and patient eligibility

About

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 advanced or metastatic malignancies

Full 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.

Enrollment

118 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 * 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

* The following B-cell neoplasms: Burkitt lymphoma, lymphoblastic leukemia/lymphoma, lymphoplasmacytic lymphoma, chronic lymphocytic leukemia * 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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

118 participants in 1 patient group

MCLA-145
Experimental group
Description:
In 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 ( 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
Treatment:
Drug: MCLA-145

Trial contacts and locations

10

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Central trial contact

Gianluca Laus, MD; Andrew Joe, MD

Data sourced from clinicaltrials.gov

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