This is an open-label, non-randomized, Phase 1 study to determine the safety, tolerability, and preliminary efficacy of MCLA-145 in adult patients with advanced metastatic solid tumors or B-cell lymphomas. The study will be conducted in 2 parts.
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 of MCLA-145 in monotherapy or in combination with pembrolizumab. Part 2 is a dose expansion to confirm the dose of MCLA-145, alone or in combination 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 for patients treated Q2W and 21 days for patients treated Q3W); Safety Follow-up (30 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
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
full-length IgG1 bispecific antibody specifically targeting PD-L1 and CD137
Group B patients will be treated in combination with MCLA-145 and pembrolizumab 200mg Q3W.
Moores Cancer Centre
La Jolla, California, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University Hospital Antwerp
Antwerp, Edegem, Belgium
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
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
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Universitair Ziekenhuis Gent
Ghent, Belgium
Netherlands Cancer Institute
Amsterdam, Netherlands
Hospital Universitario Fundarcion Jimenez Diaz
Madrid, Spain
Clinica Universidad de Navarra
Pamplona, Spain