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MGD007

Phase 1

Colorectal Carcinoma | Small molecule | Oncology |MacroGenics, Inc.|Last Updated: Feb 8, 2022

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment95

FDA Designations

No designations recorded

Clinical trial landscape

MGD007 · 1 trial · 1 indication

Phase 1 1
NCT02248805Phase 1 Study of MGD007 in Relapsed/Refractory Metastatic Colorectal CarcinomaColorectal Carcinoma
COMPLETED95 Analytics
PHASE1COMPLETED
Phase 1 Study of MGD007 in Relapsed/Refractory Metastatic Colorectal Carcinoma
Colorectal Carcinoma
NCT0224880595
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Study Endpoints

Primary Endpoints

Characterize dose limiting toxicity and establish a maximum tolerated dose and schedule
Cycle 1 of a 6 week cycle

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.

Secondary Endpoints

Characterize the PK and Immunogenicity of MGD007
Beginning of treatment through end of treatment, an expected duration of less than 12 months
Describe any evidence of anti-tumor activity
Every 6 weeks until End of Study, an expected duration of less than 12 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Does Escalation Arm AEXPERIMENTALMGD007 treatment once weekly
Dose Escalation Arm BEXPERIMENTALMGD007 treatment once every 3 weeks
Dose Expansion Arm CEXPERIMENTALMGD007 once every 3 weeks for K-ras wild-type and mutant metastatic CRC
Dose Expansion ArmsEXPERIMENTALMGD007 2, 3, 6, or 12 doses/cycle

Interventions

NameTypeDescription
MGD007DRUGMGD007 is a gpA33 x CD3 bi-specific antibody-based molecular construct referred to as a DART molecule. MGD007 will be administered as a single agent.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

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 adenocarcinom...

Countries:United States
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Frequently asked questions about MGD007

What is MGD007 used for?

MGD007 is an investigational oncology drug being studied for the treatment of colorectal carcinoma and metastatic colorectal cancer. It has been evaluated in patients with relapsed or refractory disease, meaning cancer that has returned or not responded to prior treatments. The drug is currently in clinical development and is not approved by regulatory authorities.

Who makes MGD007?

MGD007 is being developed by MacroGenics, Inc., a biopharmaceutical company. MacroGenics is publicly traded on the NASDAQ under the ticker symbol MGNX. The company is conducting clinical trials to evaluate the safety and efficacy of MGD007 in patients with colorectal cancer.

What phase is MGD007 in?

MGD007 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one studying MGD007 as a monotherapy and another studying it in combination with MGA012. The drug remains investigational and has not received FDA approval for any indication.

What clinical trials is MGD007 in?

MGD007 has been studied in two completed Phase 1 clinical trials. The first, NCT02248805, evaluated MGD007 alone in patients with relapsed or refractory metastatic colorectal carcinoma. The second, NCT03531632, studied MGD007 in combination with MGA012 in patients with relapsed or refractory metastatic colorectal cancer. Both trials were conducted in the United States.

Is MGD007 the same as MGA012?

No, MGD007 and MGA012 are different investigational drugs. MGD007 is being studied as a monotherapy and in combination with MGA012. A completed Phase 1 trial, NCT03531632, evaluated the combination of MGD007 and MGA012 in patients with relapsed or refractory metastatic colorectal cancer.