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Experimental drug duo targets Hard-to-Treat cancers

NCT ID NCT05293496

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-phase trial tested a combination of two experimental drugs, vobramitamab duocarmazine and lorigerlimab, in 31 people with advanced solid tumors like prostate, melanoma, and pancreatic cancer. The main goal was to check safety and find the right dose. Participants received the drugs every 4 weeks for up to 2 years, with regular tumor scans to see if the cancer shrank.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vobramitamab duocarmazine (MGC018) and lorigerlimab (MGD019)
What this could lead to
If successful, this could point toward a new combination treatment for several advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is a very early, small Phase 1 trial with only 31 participants, so safety and dosing are the main focus. The combination may not shrink tumors or could cause significant side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

31 people

The number who actually took part.

Started

Apr 2022

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Carolina BioOncology

    Huntersville, North Carolina, 28078, United States

  • Florida Cancer Specialists and Research Institute

    Sarasota, Florida, 34232, United States

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287, United States

  • Stephenson Cancer Center, The University of Oklahoma

    Oklahoma City, Oklahoma, 73104, United States

  • University of California, Los Angeles

    Los Angeles, California, 90095, United States

  • University of California, San Francisco

    San Francisco, California, 94115, United States

  • University of Pittsburgh Medical Center, Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia, 22908, United States

  • Weill Cornell Medicine

    New York, New York, 10065, United States

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.