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Monoclonal Antibody

MGC018 + MGD019 for Solid Tumors

Phase 1
Recruiting
Research Sponsored by MacroGenics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants diagnosed with advanced solid tumors including metastatic castration-resistant prostate cancer, melanoma, pancreatic cancer, hepatocellular carcinoma, ovarian cancer and renal cell carcinoma.
Eastern Cooperative Oncology Group performance status of less than or equal to 2
Must not have
History of Guillain-Barre syndrome, myasthenia gravis, or other autoimmune sensory or motor neuropathies
Prior autologous/allogeneic stem cell or tissue/solid organ transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

Summary

This trial is studying the effects of two drugs, MGC018 and lorigerlimab, when used in combination to treat patients with relapsed or refractory solid tumors, including metastatic prostate cancer, melanoma, pancreatic cancer, hepatocellular carcinoma, ovarian cancer, or renal cell carcinoma.

Who is the study for?
This trial is for adults with advanced solid tumors, including specific cancers like prostate, melanoma, pancreatic, liver, ovarian, and kidney cancer. Participants must have a life expectancy of at least 12 weeks and should have tried approved treatments already. They need to be able to consent to the study's procedures and agree to use effective contraception. People with certain medical conditions or those who've had other recent malignancies are not eligible.Check my eligibility
What is being tested?
The trial tests vobramitamab duocarmazine (MGC018) in combination with lorigerlimab on patients with various advanced solid tumors. It aims to evaluate safety, tolerability and initial effectiveness of these drugs given every four weeks up to two years unless there's disease progression or unacceptable side effects.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system since both drugs affect it; this could lead to inflammation in different body parts. Other common drug-related side effects might involve fatigue, digestive issues or changes in blood counts that can increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have an advanced solid tumor such as prostate, melanoma, pancreatic, liver, ovarian, or kidney cancer.
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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of Guillain-Barre syndrome, myasthenia gravis, or similar conditions.
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I have had a stem cell or organ transplant before.
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I had severe side effects from previous immune therapy, but they are mostly resolved.
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I have not been treated with MGD009, enoblituzumab, or similar drugs targeting B7-H3 for cancer.
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I do not have serious heart, lung, vein, or stomach conditions.
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I have mild to severe numbness, tingling, or pain in my hands or feet.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with AEs leading to study treatment discontinuation
Number of participants with adverse events (AEs)
Number of participants with serious adverse events (SAEs)
Secondary outcome measures
Area under the concentration-time curve during the dosing interval (AUCtau) of lorigerlimab
Area under the concentration-time curve during the dosing interval (AUCtau) of vobramitamab duocarmazine
Best PSA percent change for mCRPC
+16 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: Cohort ExpansionExperimental Treatment2 Interventions
maximum tolerated dose of vobramitamab duocarmazine and lorigerlimab IV every 4 weeks
Group II: Cohort 5Experimental Treatment2 Interventions
vobramitamab duocarmazine at dose level 4 and lorigerlimab IV every 4 weeks
Group III: Cohort 4Experimental Treatment2 Interventions
vobramitamab duocarmazine at dose level 3 and lorigerlimab IV every 4 weeks
Group IV: Cohort 3Experimental Treatment2 Interventions
vobramitamab duocarmazine at dose level 2 and lorigerlimab IV every 4 weeks
Group V: Cohort 2Experimental Treatment2 Interventions
vobramitamab duocarmazine at dose level 1 and lorigerlimab IV every 4 weeks
Group VI: Cohort 1Experimental Treatment2 Interventions
vobramitamab duocarmazine at dose level 1 and lorigerlimab IV every 4 weeks
Group VII: Cohort -1Experimental Treatment2 Interventions
vobramitamab duocarmazine at dose level -1 and lorigerlimab intravenously (IV) every 4 weeks

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for liver cancer include antibody-drug conjugates (ADCs) and bispecific antibodies. ADCs, such as vobramitamab duocarmazine, combine a monoclonal antibody specific to cancer cells with a cytotoxic drug, allowing targeted delivery of the drug to cancer cells while minimizing damage to healthy cells. Bispecific antibodies, like lorigerlimab, are designed to bind to two different antigens simultaneously, enhancing the immune system's ability to recognize and attack cancer cells. These targeted therapies are significant for liver cancer patients as they offer a more precise treatment approach, potentially improving efficacy and reducing side effects compared to traditional chemotherapy.
The evolving treatment paradigm of advanced hepatocellular carcinoma: putting all the pieces back together.Dramatic response to dabrafenib and trametinib combination in a BRAF V600E-mutated cholangiocarcinoma: implementation of a molecular tumour board and next-generation sequencing for personalized medicine.New and emerging combination therapies for esophageal cancer.

Find a Location

Who is running the clinical trial?

MacroGenicsLead Sponsor
48 Previous Clinical Trials
5,101 Total Patients Enrolled
Chet Bohac, MD PharmD MScStudy DirectorMacroGenics
2 Previous Clinical Trials
87 Total Patients Enrolled
Stephen L. Eck, M.D.Study DirectorMacroGenics

Media Library

Lorigerlimab (Monoclonal Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT05293496 — Phase 1
Liver Cancer Research Study Groups: Cohort 3, Cohort 5, Cohort 2, Cohort 4, Cohort Expansion, Cohort -1, Cohort 1
Liver Cancer Clinical Trial 2023: Lorigerlimab Highlights & Side Effects. Trial Name: NCT05293496 — Phase 1
Lorigerlimab (Monoclonal Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05293496 — Phase 1
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