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A Study of MGC026 in Participants With Advanced Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Study of MGC026 in Participants With Advanced Solid Tumors

A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors

NCT06242470•MacroGenics

View on ClinicalTrials.gov

Summary

The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study. Participants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults ≥ 18 years old, able to provide informed consent
•Adequate performance and laboratory parameters
•Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an archival tumor sample is not available. Participants with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible
•Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.
•Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.
•Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.
•Not pregnant or breastfeeding.

Exclusion Criteria

•Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
•Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score \< 6), or carcinoma in situ.
•Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.
•Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.
•Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload.
•Prior autologous or allogeneic stem cell or solid organ transplant.
•Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.
•Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration.
•Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction.
•Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.
+3 more criteria

Locations (12)

The Angeles Clinic and Research Institute

Los Angeles, California, United States

START Midwest

Grand Rapids, Michigan, United States

START-New York Long Island

Lake Success, New York, United States

Providence Cancer Institute

Portland, Oregon, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

START Mountain Region

West Valley City, Utah, United States

ICON Cancer Centre Wesley

Auchenflower, Queensland, Australia

ICON Cancer Centre Kurralta Park

Kurralta Park, South Australia, Australia

Austin Health- Olivia Newton John Cancer Center

Heidelberg, Victoria, Australia

Key Dates

Start Date

March 6, 2024

Primary Completion Date

May 1, 2028

Completion Date

October 1, 2028

Last Updated

February 5, 2026

Enrollment

250

ESTIMATED participants

Conditions

Advanced Solid TumorAdvanced CancerMetastatic CancerSquamous Cell Carcinoma of Head and NeckNon Small Cell Lung CancerSmall-cell Lung CancerBladder CancerSarcomaEndometrial CancerMelanomaCastration Resistant Prostatic CancerCervical CancerColorectal CancerGastric CancerGastro-esophageal CancerPancreas CancerClear Cell Renal Cell CarcinomaHepatocellular CarcinomaPlatinum-resistant Ovarian CancerBreast CancerOvarian CancerEsophageal Squamous Cell Cancer (SCC)

Interventions

MGC026 Dose Escalation

BIOLOGICAL

MGC026 Dose for Expansion

BIOLOGICAL

Contacts

Global Trial Manager

CONTACT

301-251-5172 info@macrogenics.com

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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: February 5, 2026Data 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.

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A Study of MGC026 in Participants With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

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