A Study of MGC026 in Participants With Advanced Solid Tumors

Clinicaltrials.gov ID: NCT06242470
db-list-check Status RECRUITING
b-loader Phase PHASE1
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 230

Conditions

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

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.

Locations

5 locations Found with status Recruiting

Status

  • RECRUITING

Central Contacts

Study Director

  • Denise Casey, MD

Status

  • RECRUITING

Central Contacts

Study Director

  • Denise Casey, MD

Status

  • RECRUITING

Central Contacts

Study Director

  • Denise Casey, MD

Status

  • RECRUITING

Central Contacts

Study Director

  • Denise Casey, MD

Status

  • RECRUITING

Central Contacts

Study Director

  • Denise Casey, MD

Eligibility Criteria

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.

Study Plan

Cohort 1

  • BIOLOGICAL:

    MGC026 Dose Escalation

    Description:

    Escalating doses of MGC026

Cohort 2

  • BIOLOGICAL:

    MGC026 Dose Escalation

    Description:

    Escalating doses of MGC026

Cohort 3

  • BIOLOGICAL:

    MGC026 Dose Escalation

    Description:

    Escalating doses of MGC026

Cohort 4

  • BIOLOGICAL:

    MGC026 Dose Escalation

    Description:

    Escalating doses of MGC026

Cohort 5

  • BIOLOGICAL:

    MGC026 Dose Escalation

    Description:

    Escalating doses of MGC026

Cohort 6

  • BIOLOGICAL:

    MGC026 Dose Escalation

    Description:

    Escalating doses of MGC026

Expansion cohort 1

  • BIOLOGICAL:

    MGC026 Dose for Expansion

    Description:

    MGC026 recommended dose for expansion

Expansion cohort 2

  • BIOLOGICAL:

    MGC026 Dose for Expansion

    Description:

    MGC026 recommended dose for expansion

Expansion cohort 3

  • BIOLOGICAL:

    MGC026 Dose for Expansion

    Description:

    MGC026 recommended dose for expansion

Expansion cohort 4

  • BIOLOGICAL:

    MGC026 Dose for Expansion

    Description:

    MGC026 recommended dose for expansion

Outcome Measures

Primary Outcome Measures

Number of participants with adverse events (AEs) and serious AEs (SAEs)

Time Frame: Throughout the study, up to 135 weeks

Secondary Outcome Measures

Overall response rate in advanced solid tumors

Time Frame: Throughout the study, up to 135 weeks

Duration of response (DoR) in advanced solid tumors

Time Frame: Throughout the study, up to 135 weeks

ORR rate in metastatic castration resistant prostate cancer (mCRPC)

Time Frame: Throughout the study, up to 135 weeks

DoR in mCRPC

Time Frame: Throughout the study, up to 135 weeks

Mean (standard deviation [SD]) of MGC026 maximum serum concentration (Cmax)

Time Frame: Day 1 of every 21-day cycle, throughout the study, average of 1 year.

Mean (SD) of MGC026 area under the time concentration curve (AUC)

Time Frame: Day 1 of every 21-day cycle, throughout the study, average of 1 year.

Number of participants who develop anti-MGC026 antibodies (immunogenicity)

Time Frame: Day 1 of every 21-day cycle, throughout the study, average of 1 year.

Timeline

  • Last Updated
    November 25, 2024
  • Start Date
    February 5, 2024
  • Today
    January 16, 2025
  • Completion Date ( Estimated )
    October 1, 2028

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