Clinical Trial 18051

Cancer Type: Gastrointestinal Tumor
Interventions:MGD007

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Richard Kim

Overview

Study Title

A Phase 1, First-in-Human, Open Label, Dose Escalation Study of MGD007, A Humanized gpA33 x CD3 Dual-Affinity Re-Targeting (DART) Protein in Patients with Relapsed/Refractory Metastatic Colorectal Carcinoma

Summary

The primary goal of this Phase 1 study is to characterize the safety and tolerability of MGD007 and establish the maximum tolerated dose (MTD) of MGD007 administered on either weekly or every three week schedules of administration among patients with metastatic colorectal carcinoma. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of MGD007 will also be assessed.

Objective

Primary Objective(s): To characterize the safety, tolerability, dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of MGD007 when administered intravenously (IV) on weekly and every three week schedules in patients with relapsed/refractory metastatic colorectal carcinoma.

Inclusion Criteria

  • For the dose escalation group, histologically-proven metastatic colorectal adenocarcinoma that is refractory to 2 prior standard treatment regimens or standard treatment was declined
  • For the dose expansion group, histologically-proven metastatic colorectal adenocarcinoma that is refractory to 1 prior standard treatment regimen or standard therapy was declined
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of at least 12 weeks
  • Measurable disease
  • Intolerance to at least 2 prior standard therapy regimens
  • Acceptable laboratory parameters
  • Adult (≥18 years old)

  • Exclusion Criteria

  • Known brain metastasis
  • Any prior history of or suspected current autoimmune disorders (with the exception of vitiligo, resolved childhood atopic dermatitis, prior Grave's disease)
  • Prior history of allogeneic bone marrow, stem-cell, or solid organ transplantation
  • Prior treatment with checkpoint inhibitors and other immunotherapy treatments, including anti-LAG-3, anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibodies, if less than 5 half-lives before study drug administration
  • Prior history of Grade 3 or greater drug-related diarrhea/colitis during treatment with checkpoint inhibitors or other immunotherapy treatments
  • Treatment with any local or systemic anti-neoplastic therapy or any other investigational agent in the 4 weeks prior to study drug administration
  • Require, at the time of study entry, treatment with steroids > 10 mg/day of oral prednisone (or equivalent), except topical use, steroid inhaler, nasal spray or ophthalmic solution
  • History of clinically significant cardiovascular disease, gastrointestinal disorder, or significant pulmonary compromise
  • Second primary malignancy that has not been in remission for greater than 3 years, with the exception of non-melanoma skin cancer, cervical carcinoma in situ,or squamous intraepithelial lesion on PAP smear, localized prostate cancer (Gleason score less than 6), or resected melanoma in situ