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Advanced Solid TumorPhase 1NCT05293496

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

A Phase 1 study testing vobramitamab duocarmazine and lorigerlimab in people with Advanced Solid Tumor and Castration-Resistant Prostatic Cancer, run by MacroGenics at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
vobramitamab duocarmazine and lorigerlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
10 sitesUnited States
Study dates
19 Apr 2022to 26 Aug 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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 locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287

  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia, 22908

  • Carolina BioOncology

    Huntersville, North Carolina, 28078

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • Weill Cornell Medicine

    New York, New York, 10065

  • Stephenson Cancer Center, The University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • University of Pittsburgh Medical Center, Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • University of California, San Francisco

    San Francisco, California, 94115

  • Florida Cancer Specialists and Research Institute

    Sarasota, Florida, 34232

Other trials in United States

About this study

Official title: A Phase 1/1b Dose Escalation and Cohort Expansion Study of MGC018 in Combination With Checkpoint Inhibitor 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.

Read more

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. .

Being tested
vobramitamab duocarmazine, lorigerlimab
Medical subject headings
Prostatic Neoplasms, Castration-Resistant, Melanoma, Carcinoma, Pancreatic Ductal, Liver Neoplasms, Carcinoma, Ovarian Epithelial, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vobramitamab duocarmazineBiological

    Also called MGC018

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

  • lorigerlimabBiological

    Also called MGD019

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

Study groups in NCT05293496
Study groupRoleWhat they receive
Cohort -1Experimentalvobramitamab duocarmazine at dose level -1 and lorigerlimab intravenously (IV) every 4 weeks
Receives: Biological: vobramitamab duocarmazine; Biological: lorigerlimab
Cohort 1Experimentalvobramitamab duocarmazine at dose level 1 and lorigerlimab IV every 4 weeks
Receives: Biological: vobramitamab duocarmazine; Biological: lorigerlimab
Cohort 2Experimentalvobramitamab duocarmazine at dose level 1 and lorigerlimab IV every 4 weeks
Receives: Biological: vobramitamab duocarmazine; Biological: lorigerlimab
Cohort 3Experimentalvobramitamab duocarmazine at dose level 2 and lorigerlimab IV every 4 weeks
Receives: Biological: vobramitamab duocarmazine; Biological: lorigerlimab
Cohort 4Experimentalvobramitamab duocarmazine at dose level 3 and lorigerlimab IV every 4 weeks
Receives: Biological: vobramitamab duocarmazine; Biological: lorigerlimab
Cohort 5Experimentalvobramitamab duocarmazine at dose level 4 and lorigerlimab IV every 4 weeks
Receives: Biological: vobramitamab duocarmazine; Biological: lorigerlimab
Cohort ExpansionExperimentalmaximum tolerated dose of vobramitamab duocarmazine and lorigerlimab IV every 4 weeks
Receives: Biological: vobramitamab duocarmazine; Biological: lorigerlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events (AEs)

    Measured: Up to 2 years

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

    Measured: Up to 2 years

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

    Measured: Up to 2 years

Secondary outcomes (19)

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

    Peak concentration of vobramitamab duocarmazine

    Measured: Throughout the study, up to 2 years

  2. Mean maximum observed concentration (Cmax) of lorigerlimab

    Peak concentration of lorigerlimab

    Measured: Throughout the study, up to 2 years

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

    Time at which peak concentration of vobramitamab duocarmazine is observed

    Measured: Throughout the study, up to 2 years

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

    Time at which peak concentration of lorigerlimab is observed

    Measured: Throughout the study, up to 2 years

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

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

    Measured: Throughout the study, up to 2 years

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

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

    Measured: Throughout the study, up to 2 years

  7. Mean trough concentration of vobramitamab duocarmazine

    Concentration of vobramitamab duocarmazine at the end of a dosing interval

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

  8. Mean trough concentration of lorigerlimab

    Concentration of lorigerlimab at the end of a dosing interval

    Measured: Throughout the study, up to 2 years

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

    Measured: Throughout the study, up to 2 years

  10. Number of participants who develop ADA to lorigerlimab

    Measured: Throughout the study, up to 2 years

  11. Objective response rate (ORR)

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

  12. Median progression free survival (PFS)

    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.

    Measured: 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.

  13. Median duration of response (DoR)

    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.

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

  14. Median overall survival (OS)

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

    Measured: 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

  15. Median radiographic PFS (rPFS) for mCRPC

    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

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

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

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

    Measured: 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.

  17. Best PSA percent change from baseline for mCRPC

    Measured: 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

    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.

    Measured: 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.

  19. Median duration of PSA response for mCRPC

    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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2022
  2. Study start19 Apr 2022
  3. Primary completion24 Jun 2025
  4. Study completion26 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05293496
Sponsor's protocol ID
CP-MGC018-02
Status last verified
Oct 2025
First submitted
12 Feb 2022
Last updated
14 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing vobramitamab duocarmazine and lorigerlimab in people with Advanced Solid Tumor and Castration-Resistant Prostatic Cancer, run by MacroGenics at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (AEs) (time frame: Up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05293496.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.

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