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

Study Identifier:
CP-MGC026-01
CT.gov Identifier:
NCT06242470
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
  • Unspecified Cancer
  • Metastatic Cancer
  • HNSCC
  • Non-Small Cell Lung Cancer
  • Small Cell Lung
  • Bladder
  • Sarcoma
  • Endometrial
  • Melanoma
  • Prostate
  • Cervical cancer
  • Bowel (Colorectal)
  • Gastric
  • Gastroesophageal
  • Pancreas
  • Renal
  • Liver
  • Ovarian
  • Breast Cancers
  • Esophageal
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Cohort 1
    • Read More
  • Drug: Experimental: Cohort 2Biological: MGC026 Dose Escalation
  • Drug: Experimental: Cohort 3Biological: MGC026 Dose Escalation
  • Drug: Experimental: Cohort 4Biological: MGC026 Dose Escalation
  • Drug: Experimental: Cohort 5Biological: MGC026 Dose Escalation
  • Drug: Experimental: Cohort 6Biological: MGC026 Dose Escalation
  • Drug: Experimental: Expansion cohort 1Biological: MGC026 Dose for Expansion
  • Drug: Experimental: Expansion cohort 2Biological: MGC026 Dose for Expansion
  • Drug: Experimental: Expansion cohort 3Biological: MGC026 Dose for Expansion
  • Drug: Experimental: Expansion cohort 4Biological: MGC026 Dose for Expansion
  • Drug: Experimental: Expansion Cohort 5
  • Drug: Experimental: Expansion Cohort 6
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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 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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    Justin Call
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Unspecified Cancer
    Metastatic Cancer
    HNSCC
    Non-Small Cell Lung Cancer
    Small Cell Lung
    Bladder
    Sarcoma
    Endometrial
    Melanoma
    Prostate
    Cervical cancer
    Bowel (Colorectal)
    Gastric
    Gastroesophageal
    Pancreas
    Renal
    Liver
    Ovarian
    Breast Cancers
    Esophageal
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Unspecified Cancer
    Metastatic Cancer
    HNSCC
    Non-Small Cell Lung Cancer
    Small Cell Lung
    Bladder
    Sarcoma
    Endometrial
    Melanoma
    Prostate
    Cervical cancer
    Bowel (Colorectal)
    Gastric
    Gastroesophageal
    Pancreas
    Renal
    Liver
    Ovarian
    Breast Cancers
    Esophageal
    Location
    START New York (Long Island)
    Lake Success, NY, United States, 11042
    Investigator
    Geraldine O'Sullivan Coyne
    Status
    Will Be Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Unspecified Cancer
    Metastatic Cancer
    HNSCC
    Non-Small Cell Lung Cancer
    Small Cell Lung
    Bladder
    Sarcoma
    Endometrial
    Melanoma
    Prostate
    Cervical cancer
    Bowel (Colorectal)
    Gastric
    Gastroesophageal
    Pancreas
    Renal
    Liver
    Ovarian
    Breast Cancers
    Esophageal