Recruiting
Phase 1

MGC026

Sponsor:

MacroGenics

Code:

NCT06242470

Conditions

Advanced Solid Tumor

Advanced Cancer

Metastatic Cancer

Squamous Cell Carcinoma of Head and Neck

Non Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MGC026 Dose Escalation

MGC026 Dose for Expansion

Study Details

Brief 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.

Conditions

Advanced Solid Tumor

Advanced Cancer

Metastatic Cancer

Squamous Cell Carcinoma of Head and Neck

Non Small Cell Lung Cancer

Study ID

NCT06242470

Start date

Mar 6, 2024

Status verified date

Aug, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.
  • History of primary immunodeficiency.
  • Major trauma or major surgery within 4 weeks of first study drug administration.
  • Known hypersensitivity to recombinant proteins.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

MGC026 is a topoisomerase 1 inhibitor (TOP1i)-based ADC that targets B7-H3 administered IV every 3 weeks.

experimental: Cohort 2

experimental: Cohort 3

experimental: Cohort 4

experimental: Cohort 5

experimental: Cohort 6

experimental: Expansion cohort 1

experimental: Expansion cohort 2

experimental: Expansion cohort 3

experimental: Expansion cohort 4

experimental: Expansion Cohort 5

experimental: Expansion Cohort 6

Interventions

MGC026 Dose Escalation

Escalating doses of MGC026

MGC026 Dose for Expansion

MGC026 recommended dose for expansion

Primary outcome measure

  • Number of participants with adverse events (AEs) and serious AEs (SAEs), AEs leading to dose delay, AEs leading to dose reduction, AEs leading to treatment discontinuations, AEs meeting criteria for dose limiting toxicity, and AEs of special interest. [ Time Frame: Throughout the study, up to 135 weeks ]

Central Contacts and Locations

Central contacts

Global Trial Manager

301-251-5172info@macrogenics.com

Locations

The Angeles Clinic and Research Institute

Recruiting

Los Angeles, California, United States, 90025

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

START-New York Long Island

Recruiting

Lake Success, New York, United States, 11042

Providence Cancer Institute

Recruiting

Portland, Oregon, United States, 97213

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

START Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

More Information

Sponsor

MacroGenics

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by MacroGenics on 2026-08-11.