Colorectal Carcinoma Clinical Trial
Official title:
A Phase 1, First-in-Human, Open Label, Dose Escalation Study of MGD007, A Humanized gpA33 x CD3 DART® Protein in Patients With Relapsed/Refractory Metastatic Colorectal Carcinoma
Verified date | February 2022 |
Source | MacroGenics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary goal of this Phase 1 study is to characterize the safety and tolerability of MGD007 and establish the maximum tolerated dose (MTD) and schedule of MGD007 administered to patients with metastatic colorectal carcinoma. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of MGD007 will also be assessed.
Status | Completed |
Enrollment | 95 |
Est. completion date | July 2, 2018 |
Est. primary completion date | July 2, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - For the dose escalation cohorts, histologically-proven metastatic colorectal adenocarcinoma that is refractory to 2 prior standard treatment regimens or standard treatment was declined. - For the dose expansion cohorts, 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 <6), or resected melanoma in situ. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Carolina Biooncology Institute | Huntersville | North Carolina |
United States | Yale University, Yale Cancer Center | New Haven | Connecticut |
United States | Providence Portland Medical Center | Portland | Oregon |
United States | H. Lee Moffitt Cancer Center & Research Institute, Inc | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
MacroGenics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Characterize dose limiting toxicity and establish a maximum tolerated dose and schedule | Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit. The MTD will be defined separately for both the weekly and every three week schedules of MGD007 administration, and will be determined as the highest dose level at which the incidence of DLT is < 33% during the first cycle of MGD007 treatment. | Cycle 1 of a 6 week cycle | |
Secondary | Characterize the PK and Immunogenicity of MGD007 | Serum concentrations of MGD007 will be monitored. PK modeling will be performed and an appropriate model will be selected to describe the data. | Beginning of treatment through end of treatment, an expected duration of less than 12 months | |
Secondary | Describe any evidence of anti-tumor activity | Obtain regular radiographic and clinical evaluations to assess treatment response. | Every 6 weeks until End of Study, an expected duration of less than 12 months |
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