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A Study of MGC026 in Participants With Advanced Solid Tumors

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MacroGenics

Status and phase

Enrolling
Phase 1

Conditions

Small-cell Lung Cancer
Melanoma
Advanced Solid Tumor
Pancreas Cancer
Castration Resistant Prostatic Cancer
Non Small Cell Lung Cancer
Clear Cell Renal Cell Carcinoma
Gastro-esophageal Cancer
Platinum-resistant Ovarian Cancer
Endometrial Cancer
Metastatic Cancer
Advanced Cancer
Sarcoma
Bladder Cancer
Gastric Cancer
Squamous Cell Carcinoma of Head and Neck
Hepatocellular Carcinoma
Cervical Cancer
Colorectal Cancer

Treatments

Biological: MGC026 Dose for Expansion
Biological: MGC026 Dose Escalation

Study type

Interventional

Funder types

Industry

Identifiers

NCT06242470
CP-MGC026-01

Details and patient eligibility

About

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.

Enrollment

230 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adults ≥ 18 years old, able to provide informed consent
  • Adequate performance and laboratory parameters
  • 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 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

230 participants in 10 patient groups

Cohort 1
Experimental group
Treatment:
Biological: MGC026 Dose Escalation
Cohort 2
Experimental group
Treatment:
Biological: MGC026 Dose Escalation
Cohort 3
Experimental group
Treatment:
Biological: MGC026 Dose Escalation
Cohort 4
Experimental group
Treatment:
Biological: MGC026 Dose Escalation
Cohort 5
Experimental group
Treatment:
Biological: MGC026 Dose Escalation
Cohort 6
Experimental group
Treatment:
Biological: MGC026 Dose Escalation
Expansion cohort 1
Experimental group
Treatment:
Biological: MGC026 Dose for Expansion
Expansion cohort 2
Experimental group
Treatment:
Biological: MGC026 Dose for Expansion
Expansion cohort 3
Experimental group
Treatment:
Biological: MGC026 Dose for Expansion
Expansion cohort 4
Experimental group
Treatment:
Biological: MGC026 Dose for Expansion

Trial contacts and locations

11

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Central trial contact

Global Trial Manager

Data sourced from clinicaltrials.gov

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