Last updated on February 2018

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 agent 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. Part 1 has been completed.

Part 2 patient populations of interest to receive the RP2D determined in Part 1 are:

  • relapsed/refractory HER2-amplified breast cancer (Group A);
  • advanced/metastatic epithelial ovarian cancer (Group C);
  • advanced/metastatic HER2-amplified gastric cancer or esophageal-gastric junction adenocarcinoma (Group D); .
  • advanced/metastatic endometrial cancer (Group E);
  • advanced/metastatic or recurring HER2 expressing non small cell lung cancer (Group F);

Part 2 will further characterize the safety and tolerability of the selected dose level 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).

The study consists of 3 periods: Screening period (up to 28 days prior to the first dose of study drug) Treatment period (first dose of study drug until the last dose of study drug with treatment cycles of 21 days) and 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.

Number of Sites:

Up to 10 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 Additional sites may be added to ensure there is an acceptable enrollment rate or to replace non-enrolling/withdrawn sites.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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Recruitment Status: Open

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