What side effects are associated with this type of intervention?

Common treatments for liver cancer, such as antibody-drug conjugates and bispecific antibodies, often have side effects including fatigue, diarrhea, hypertension, and liver enzyme abnormalities. Specific to antibody-drug conjugates like Vobramitamab Duocarmazine, side effects can include infusion-related reactions, cytopenias, and potential liver toxicity. Bispecific antibodies like Lorigerlimab may cause immune-related adverse events such as colitis, dermatitis, and endocrinopathies. These treatments aim to target cancer cells more precisely but can still affect normal tissues, leading to these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for advanced hepatocellular carcinoma (HCC). Sorafenib (Nexavar), a multitargeted tyrosine kinase inhibitor, was one of the first systemic treatments approved for unresectable HCC. More recently, immune checkpoint inhibitors like Atezolizumab in combination with Bevacizumab have shown significant efficacy and received approval. These treatments, while not identical, share a focus on targeted and immune-based therapies similar to the investigational drugs Vobramitamab Duocarmazine and Lorigerlimab.

What other types of research exist?

Promising alternatives for liver cancer treatment in 2024 include the combination of cabozantinib (a multikinase inhibitor) and atezolizumab (an immune checkpoint inhibitor), which has shown synergistic effects in advanced HCC. Additionally, the combination of atezolizumab and bevacizumab has been approved as a first-line therapy based on its superiority over sorafenib. Another promising combination is durvalumab and tremelimumab, which demonstrated improved overall survival in the HIMALAYA trial.

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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

No Placebo-Only Group

Summary

This trial tests two experimental drugs on patients with advanced cancers that haven't responded to other treatments. One drug aims to kill cancer cells directly, while the other boosts the immune system to fight the cancer.

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.

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.

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 weeks3 visits

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

Duration of PSA response for mCRPC

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 8Eligibility criteria met

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.