A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti–B7-H3 Antibody Drug Conjugate) Alone and in Combination with MGA012 (Anti–PD-1 Antibody) in Patients with Advanced Solid Tumors

MacroGenics, Inc.0 sites182 target enrollmentJune 12, 2019

Overview

No summary available.

Registry

who.int

Start Date

June 12, 2019

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Ability to provide informed consent and documentation of informed consent prior to initiation of any study\-related tests or procedures that
•are not part of standard\-of\-care for the participant's disease. Participants must also be willing and able to comply with study procedures, including the acquisition of specified research specimens.
•2\. Age \= 18 years old.
•3\. Archival or FFPE tissue must be available for determination of B7\-H3 (Module A) and B7\-H3 and PD\-L1 expression (Module B). Participants
•may undergo a fresh tumor biopsy to obtain a specimen for testing if a tumor sample is not available; mCRPC with bone only disease not amenable to fresh biopsy may be eligible in consultation with the sponsor.
•4\. Eastern Cooperative Oncology Group (ECOG) performance status of \=2\.
•5\. Life expectancy \= 12 weeks for Dose Escalation Phase and \= 24 weeks for Cohort Expansion Phase.
•6\. Measurable disease as per RECIST v1\.1 criteria. Participants with mCRPC without measurable disease may be enrolled. Cutaneous or
•subcutaneous lesions must be measurable by calipers. Note: Lesions to be used as measurable disease for the purpose of response assessment
•must not reside in a field that has been subjected to prior radiotherapy

•1\. Participants with history of prior central nervous system (CNS) metastasis must have been treated, must be asymptomatic, and must
•not have any of the following at the time of enrollment:
•\- Concurrent treatment for the CNS disease (e.g., surgery, radiation, corticosteroids \> 10 mg prednisone/day or equivalent)
•\- Progression after primary treatment of CNS metastases on imaging with MRI, CT or positron emission tomography (PET)/CT within 6 months prior to screening.
•\- History of leptomeningeal disease or spinal cord compression.
•2\. Module B only: Participants with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and participants with a history of Grave’s disease that are now euthyroid clinically and by laboratory testing.
•3\. Treatment with any, investigational therapy within the 4 weeks prior to the initiation of study drug administration.
•4\. Module B only: Previous Checkpoint Inhibitor Therapy: Patients who experienced the following immune checkpoint inhibitor\-related AEs make the patient ineligible despite the AE resolving to \= Grade 1 or baseline:
•o \= Grade 3 ocular AE
•o Changes in liver function tests that met the criteria for Hy's Law (\> 3 × ULN of either ALT/AST with concurrent \> 2 × ULN of total