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A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms

A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of MGD013, A Bispecific DART® Protein Binding PD-1 and LAG-3 in Patients With Unresectable or Metastatic Neoplasms

NCT03219268•MacroGenics

View on ClinicalTrials.gov

Summary

The primary goal of this Phase 1 study is to characterize the safety and tolerability of tebotelimab and establish the maximum tolerated dose (MTD) of tebotelimab in advanced solid tumors, and tebotelimab in combination with margetuximab in HER2+ advanced solid tumors. Pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and the anti-tumor activity of tebotelimab will also be assessed.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically proven, locally advanced unresectable or metastatic solid tumors (or hematologic malignancies, Cohort Expansion only) for whom no approved therapy with demonstrated clinical benefit is available or standard treatment was declined.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•Life expectancy ≥ 12 weeks
•Measurable disease
•Tissue specimen available for retrospective analysis of PD-1, PD-L1, LAG-3, and MHC-II expression
•Acceptable laboratory parameters
•HER2+ Cohort:
•\- Locally advanced or metastatic HER2+ locally advanced or metastatic solid tumors, regardless of organ of origin.
•i. The cancer must have progressed following standard therapy, or has progressed during or after HER2-directed therapy if approved and available for patients with HER2+ breast, gastric, or gastroesophageal junction cancer.
•ii. History of HER2 positivity defined as 3+ by IHC or 2+ by Immunohistochemistry (IHC) in combination with in situ hybridization (ISH) positivity most recent tumor biopsy.
+1 more criteria

Exclusion Criteria

•Symptomatic central nervous system (CNS) metastases or primary CNS lymphoma
•History of allogeneic bone marrow, stem-cell, or solid organ transplant
•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 patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing.
•Treatment with any systemic chemotherapy within 3 weeks prior to the initiation of study drug; treatment with biologics or investigational therapy within the 4 weeks prior to the initiation of study drug.
•Major surgery within 4 weeks prior to the initiation of study drug.
•Prior treatment with combination of monoclonal antibodies against PD-1 and LAG-3 (Cohort Expansion only).
•Treatment with radiation therapy within 2 weeks prior to the initiation of study drug.
•Clinically significant cardiovascular disease.
•QTcF prolongation \> 480 milliseconds
•HER2+ cohort: left ventricular ejection fraction less than 50%
+9 more criteria

Locations (40)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

UCLA Hematology & Oncology Clinic

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Florida Cancer Specialists & Research Institute

Sarasota, Florida, United States

University of Chicago Medicine

Chicago, Illinois, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Massachusetts General Hospital and Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Duke University Medical Center

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Key Dates

Start Date

August 18, 2017

Primary Completion Date

February 8, 2023

Completion Date

February 8, 2023

Last Updated

December 21, 2023

Enrollment

277

ACTUAL participants

Conditions

Advanced Solid TumorsHematologic NeoplasmsOvarian CancerHER2-positive Advanced Solid TumorsNon Small Cell Lung CancerSmall-cell Lung CancerSquamous Cell Carcinoma of Head and NeckCholangiocarcinomaCervical CancerTNBC - Triple-Negative Breast Cancer

Interventions

tebotelimab 1 mg

BIOLOGICAL

tebotelimab 3 mg

BIOLOGICAL

tebotelimab 10 mg

BIOLOGICAL

tebotelimab 30 mg

BIOLOGICAL

tebotelimab 120 mg

BIOLOGICAL

tebotelimab 300 mg

BIOLOGICAL

tebotelimab 400 mg

BIOLOGICAL

tebotelimab 600 mg

BIOLOGICAL

tebotelimab 800 mg

BIOLOGICAL

tebotelimab 1200 mg

BIOLOGICAL

margetuximab

BIOLOGICAL

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

View study

RECRUITINGPHASE1

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

NCT05039801

Advanced Endometrial CarcinomaAdvanced Head and Neck Squamous Cell Carcinoma+36 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors