Last updated on September 2016

A Study of MCLA-128 in Patients With Solid Tumors

Brief description of study

This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single group assignment study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor activity of MCLA-128

Detailed Study Description

Study Design : This open label (all participants know the identity of the study drug), multicenter (more than one study site), first-in-human study consists of 2 parts. Part 1 is a dose escalation and Part 2 is a dose expansion cohort. In Part 1, participants with solid tumors will be enrolled into cohorts at increasing dose levels of MCLA-128, which will be administered in 21 day treatment cycles. The dose will be escalated until the maximum tolerated dose (MTD) where possible, or the maximum recommended dose (MRD) is reached. Dose escalation decisions will be made by the Data Review Committee and will be primarily guided by safety data observed through the end of Cycle 1, as well as on-going assessment of safety beyond Cycle 1 in earlier cohorts. Part 1 will follow an accelerated dose escalation scheme following the principles of Simon's accelerated study design (Simon 1997 ). The enrollment to study starts with 1 patient per cohort. The study will shift to a 3 + 3 design when either, a patient experiences a DLT, or other toxicities occur, or no clinically significant events or possible MCLA-128-related toxicity have been noted, but the DRC still recommends to switch to a conventional 3 + 3 cohort based on available data during the study. Data from Part 1 will be used to determine the RecommendedPart2Dose. Part 2 patient populations of interest to receive the RP2D determined in Part 1 are: - relapsed/refractory HER2-amplified mBC (Group A); - relapsed/refractory HER2-amplified mCRC (Group B). Part 2 will include a Simon's two-stage design (Simon 19891) to further characterize the safety and tolerability of selected dose levels of MCLA-128, as well as assessment of CBR, defined as the proportion of patients with a CR, PR or durable SD (SD for at least 12 weeks in duration), in expansion groups of selected patient populations. No within-patient dose escalation will be permitted in Part 2. For both parts, the study consists of 3 periods: a Screening period (up to 28 days prior to the first dose of study drug); a Treatment period (first dose of study drug until the last dose of study drug with treatment cycles of 21 days); and a Follow Up period (through 30 days after the last dose and quarterly checks for survival data for up to 2 years). Participants' safety will be monitored throughout the study. Patients will be permitted to receive MCLA-128 beyond Cycle 1 if conditions allow this. Number of Sites: Up to 6 sites are estimated to be involved during Parts 1 and 2 of the study. Additional sites may be added to ensure there is an acceptable enrollment rate or to replace non-enrolling/withdrawn sites.

Clinical Study Identifier: NCT02912949


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Andrea Varga, Dr

Institut Gustave Roussy
Paris, France
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Salvatore Siena, Prof

Niguarda Cancer Centre
Milan, Italy
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Jan Schellens, Prof dr.

Amsterdam, Netherlands
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Josep Tabernero, Prof Dr.

Vall D'Hebron Institute of Oncology (VHIO)
Barcelona, Spain
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Victor Moreno, Dr.

START Hospital Fundaci n Jim nez Diaz
Madrid, Spain
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Emiliano Calvo, Prof. Dr.

START Hospital Universitario Madrid Sanchinarro
Madrid, Spain
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