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NCT Number: NCT05293496

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

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. .

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Key information

Conditions

Advanced Solid Tumor Adenocarcinoma Adnexal Diseases Carcinoma Carcinoma, Ductal Carcinoma, Ovarian Epithelial Carcinoma, Pancreatic Ductal Carcinoma, Renal Cell Castration-Resistant Prostatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Epithelial Ovarian Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Hepatocellular Cancer Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Male Urogenital Diseases Malignant Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Ductal Carcinoma Pancreatic Neoplasms Prostatic Diseases Prostatic Neoplasms Prostatic Neoplasms, Castration-Resistant Renal Cell Carcinoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, Los Angeles, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

vobramitamab duocarmazine

Biological

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

Other names: MGC018

lorigerlimab

Biological

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

Other names: MGD019

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 2 years

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 2 years

  3. Number of participants with AEs leading to study treatment discontinuation

    Time frame: Up to 2 years

Secondary outcomes

  1. Mean maximum observed concentration (Cmax) of vobramitamab duocarmazine

    Time frame: Throughout the study, up to 2 years

    Peak concentration of vobramitamab duocarmazine

  2. Mean maximum observed concentration (Cmax) of lorigerlimab

    Time frame: Throughout the study, up to 2 years

    Peak concentration of lorigerlimab

  3. Mean time to maximum concentration (Tmax) of vobramitamab duocarmazine

    Time frame: Throughout the study, up to 2 years

    Time at which peak concentration of vobramitamab duocarmazine is observed

  4. Mean time to maximum concentration (Tmax) of lorigerlimab

    Time frame: Throughout the study, up to 2 years

    Time at which peak concentration of lorigerlimab is observed

  5. Mean area under the concentration-time curve during the dosing interval (AUCtau) of vobramitamab duocarmazine

    Time frame: Throughout the study, up to 2 years

    Concentration of vobramitamab duocarmazine in the bloodstream during the 28-day dosing interval after dose administration

  6. Mean area under the concentration-time curve during the dosing interval (AUCtau) of lorigerlimab

    Time frame: Throughout the study, up to 2 years

    Concentration of lorigerlimab in the bloodstream during the 28-day dosing interval after dose administration

  7. Mean trough concentration of vobramitamab duocarmazine

    Time frame: Day 1 of each cycle (every 4 weeks) up to 2 years.

    Concentration of vobramitamab duocarmazine at the end of a dosing interval

  8. Mean trough concentration of lorigerlimab

    Time frame: Throughout the study, up to 2 years

    Concentration of lorigerlimab at the end of a dosing interval

  9. Number of participants who develop anti-drug antibodies (ADA) to vobramitamab duocarmazine

    Time frame: Throughout the study, up to 2 years

  10. Number of participants who develop ADA to lorigerlimab

    Time frame: Throughout the study, up to 2 years

  11. Objective response rate (ORR)

    Time frame: Assessed every 8 weeks for the first 6 months, then every 12 weeks for up to 2 years.

  12. Median progression free survival (PFS)

    Time frame: Assessed every 8 weeks for the first 6 months, then every 12 weeks. Survival status is assessed approximately every 12 weeks after the last dose of study treatment until withdrawal of consent, lost to follow up, death, or end of the study, up to 2 years.

    PFS is defined as the time from the first dose date to the date of first documented PD or death from any cause, whichever occurs first.

  13. Median duration of response (DoR)

    Time frame: Assessed every 8 weeks for the first 6 months, then every 12 weeks for up to 2 years.

    DoR is defined as the time from the date of initial response (CR or PR) to the date of first documented PD or death from any cause, whichever occurs first.

  14. Median overall survival (OS)

    Time frame: Survival status is assessed approximately every 12 weeks after the last dose of study treatment until withdrawal of consent, lost to follow up, death, or end of the study, up to 2 years

    OS is defined as the time from the first dose date to the date of death from any cause.

  15. Median radiographic PFS (rPFS) for mCRPC

    Time frame: Assessed every 8 weeks for the first 6 months, then every 12 weeks for up to 2 years.

    rPFS is defined as the time from the first dose of study drug to the first occurrence of radiographic PD of soft tissue lesions using RECIST v1.1, or appearance of ≥ 2 new bone lesions, or death from any cause

  16. Prostate-specific antigen (PSA) response rate for mCRPC

    Time frame: PSA is assessed every 4 weeks, up to 2 years while on treatment, then every 12 weeks for up to an additional 2 years in follow-up.

    PSA response is defined as ≥ 50% decline from baseline in PSA with confirmation at least 3 weeks later.

  17. Best PSA percent change from baseline for mCRPC

    Time frame: PSA is assessed every 4 weeks, up to 2 years while on treatment, then every 12 weeks for up to an additional 2 years in follow-up.

  18. Median time to PSA progression for mCRPC

    Time frame: PSA is assessed every 4 weeks, up to 2 years while on treatment, then every 12 weeks for up to an additional 2 years in follow-up.

    PSA progression is defined as an increase that is ≥ 25% and ≥ 2 ng/mL the baseline or lowest value observed, and which confirmed by a second value at least 3 weeks later.

  19. Median duration of PSA response for mCRPC

    Time frame: PSA is assessed every 4 weeks, up to 2 years while on treatment, then every 12 weeks for up to an additional 2 years in follow-up.

    DoR of PSA is defined as the time from the date of initial PSA response to the date of first documented PSA progression or death from any cause, whichever occurs first.

Sponsors and collaborators

Lead sponsor

MacroGenics

Industry

Registry information

Official study title

A Phase 1/1b Dose Escalation and Cohort Expansion Study of MGC018 in Combination With Checkpoint Inhibitor in Participants With Advanced Solid Tumors

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 24, 2022
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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