A Study of MGC018 in Combination With MGD019 in Participants With Advanced Solid Tumors

Study Purpose

Study CP-MGC018-02 is a study of vobramitamab duocarmazine (MGC018) in combination with lorigerlimab (MGD019). The study is designed to characterize safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and preliminary antitumor activity. Participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors including, but not limited to, metastatic castration-resistant prostate cancer (mCRPC), melanoma, pancreatic cancer, hepatocellular carcinoma (HCC), ovarian cancer, and renal cell carcinoma (RCC) will be enrolled. Vobramitamab duocarmazine and lorigerlimab are administered separately on Day 1 of every 4-week (28-day) cycle at the assigned dose for each cohort. Participants who do not meet criteria for study drug discontinuation may receive study drugs for up to 2 years. Tumor assessments are performed every 8 weeks (± 7 days) for the initial 6 months on study drugs, then every 12 weeks (± 21 days) until progressive disease (PD). Participants will be followed for safety throughout the study. .

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 1.
Ability to provide and document informed consent and willing and able to comply with all study procedures.
  • - Participants diagnosed with advanced solid tumors including but not limited to metastatic castration-resistant prostate cancer, melanoma, pancreatic cancer, hepatocellular carcinoma, ovarian cancer and renal cell carcinoma.
  • - Participants have received approved therapies according to their diagnosis.
  • - Participants must have an available tumor tissue sample.
A fresh tumor biopsy may be performed if no archival sample is available.
  • - Eastern Cooperative Oncology Group performance status of less than or equal to 2.
  • - Life expectancy of at least 12 weeks.
  • - Evidence of measurable tumor for evaluation.
  • - Acceptable end organ function according to laboratory results.
  • - Patients must agree to use highly-effective contraception during the study, and not donate sperm or ova.

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 malignancy that required treatment within the past 2 years.
Participants who have had curative therapy for non-melanomatous skin cancer, localized prostate cancer (Gleason score < 6), or carcinoma in situ are eligible for the study.
  • - Active viral, bacterial, or fungal infection requiring systemic treatment within 1 week of initiation of study drug.
Participants are eligible after SARS CoV 2-related symptoms have fully recovered for ≥ 72 hours.
  • - History of immunodeficiency.
Participants with HIV are eligible if they have a CD4+ count ≥ 300/µL, undetectable viral load, and maintained on antiretroviral therapy for a minimum of 4 weeks.
  • - Prior autologous/allogeneic stem cell or tissue/solid organ transplant.
  • - Prior treatment with MGD009, enoblituzumab, or other B7-H3 targeted agents for cancer.
  • - Clinically significant cardiovascular disease, lung compromise, venous insufficiency, or gastrointestinal disorders.
  • - Participants with greater than Grade 1 peripheral neuropathy.
  • - Participants who have a history of severe adverse events (AEs) from immune checkpoint inhibitors (anti-PD-1, anti-PD-L1, or CTLA-4 inhibitors).
All other AEs from prior immune checkpoint inhibitors must be resolved to Grade 1 or less. Participants with any grade neurologic toxicity from prior immune checkpoint inhibitors are excluded.
  • - Pleural effusion or ascites.
Trace pleural or peritoneal fluid is not exclusionary.
  • - History of Guillain-Barre syndrome, myasthenia gravis, or other autoimmune sensory or motor neuropathies.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05293496
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

MacroGenics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Denise Casey, M.D.
Principal Investigator Affiliation MacroGenics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Advanced Solid Tumor, Castration-Resistant Prostatic Cancer, Malignant Melanoma, Pancreatic Ductal Carcinoma, Hepatocellular Cancer, Epithelial Ovarian Cancer, Renal Cell Carcinoma
Arms & Interventions

Arms

Experimental: Cohort -1

vobramitamab duocarmazine at dose level -1 and lorigerlimab intravenously (IV) every 4 weeks

Experimental: Cohort 1

vobramitamab duocarmazine at dose level 1 and lorigerlimab IV every 4 weeks

Experimental: Cohort 2

vobramitamab duocarmazine at dose level 1 and lorigerlimab IV every 4 weeks

Experimental: Cohort 3

vobramitamab duocarmazine at dose level 2 and lorigerlimab IV every 4 weeks

Experimental: Cohort 4

vobramitamab duocarmazine at dose level 3 and lorigerlimab IV every 4 weeks

Experimental: Cohort 5

vobramitamab duocarmazine at dose level 4 and lorigerlimab IV every 4 weeks

Experimental: Cohort Expansion

maximum tolerated dose of vobramitamab duocarmazine and lorigerlimab IV every 4 weeks

Interventions

Biological: - vobramitamab duocarmazine

Vobramitamab duocarmazine is an antibody drug conjugate (ADC) targeted against B7-H3.

Biological: - lorigerlimab

Lorigerlimab is a bispecific DART® molecule that binds PD-1 and CTLA-4.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California, Los Angeles, Los Angeles, California

Status

Recruiting

Address

University of California, Los Angeles

Los Angeles, California, 90095

University of California, San Francisco, San Francisco, California

Status

Recruiting

Address

University of California, San Francisco

San Francisco, California, 94115

Sarasota, Florida

Status

Recruiting

Address

Florida Cancer Specialists and Research Institute

Sarasota, Florida, 34232

Atlanta, Georgia

Status

Not yet recruiting

Address

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322

Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287

Weill Cornell Medicine, New York, New York

Status

Recruiting

Address

Weill Cornell Medicine

New York, New York, 10065

Carolina BioOncology, Huntersville, North Carolina

Status

Recruiting

Address

Carolina BioOncology

Huntersville, North Carolina, 28078

Oklahoma City, Oklahoma

Status

Recruiting

Address

Stephenson Cancer Center, The University of Oklahoma

Oklahoma City, Oklahoma, 73104

Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center, Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

Charlottesville, Virginia

Status

Recruiting

Address

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia, 22908

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