What is the mechanism of action of this treatment?

Common treatments for solid tumors, such as domvanalimab (Anti-TIGIT Antibody) and zimberelimab (Anti-PD-1 Antibody), work by enhancing the body's immune response against cancer cells. Domvanalimab blocks TIGIT, a protein that inhibits T-cell activity, thereby boosting the immune system's ability to attack tumors. Zimberelimab targets PD-1, a protein that reduces immune activity when engaged, thus preventing cancer cells from evading immune detection. These mechanisms are crucial for solid tumor patients as they help overcome the immunosuppressive environment created by tumors, allowing for more effective immune-mediated tumor destruction.

What side effects are associated with this type of intervention?

Common side effects of immune checkpoint inhibitors, such as those targeting PD-1 and TIGIT, include immune-related adverse events (irAEs) affecting various organ systems. These can manifest as skin rashes and itching, gastrointestinal issues like diarrhea and colitis, liver inflammation (hepatitis), endocrine disorders such as thyroiditis and adrenal insufficiency, and lung inflammation (pneumonitis). Management often involves pausing the immunotherapy and using immunosuppressive treatments like corticosteroids.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of solid tumors, including anti-PD-1 antibodies like pembrolizumab and nivolumab, and anti-PD-L1 antibodies such as atezolizumab. These drugs are used to treat various cancers, including non-small cell lung cancer, melanoma, and head and neck cancer, by enhancing the immune system's ability to target and destroy cancer cells. While anti-TIGIT antibodies like domvanalimab are still being studied, the success of other immune checkpoint inhibitors highlights their potential in cancer therapy.

What other types of research exist?

Promising alternatives to Domvanalimab and Zimberelimab for solid tumors include: 1) Relatlimab (Anti-LAG-3 Antibody) in combination with Nivolumab, which has shown efficacy in melanoma. 2) Pembrolizumab (Anti-PD-1 Antibody) combined with Lenvatinib (a multi-kinase inhibitor), which has demonstrated positive outcomes in renal cell carcinoma. 3) Atezolizumab (Anti-PD-L1 Antibody) combined with Bevacizumab and chemotherapy, which has been effective in non-small cell lung cancer. These treatments are supported by recent clinical trial data and are expected to be significant in 2024.

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Monoclonal Antibodies

Domvanalimab + Zimberelimab for Cancer

Phase 1

Waitlist Available

Research Sponsored by Arcus Biosciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first dose date to date of death, up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two experimental drugs, domvanalimab and zimberelimab, to see if they can help treat advanced cancers. The study focuses on patients whose cancers are not responding well to standard treatments. These drugs work by boosting the body's immune system to better fight the cancer.

Who is the study for?

Adults with advanced solid tumors who can consent, have a performance status score of 0 or 1, and no standard therapy options left. They must not be pregnant, breastfeeding, or planning to conceive soon. Participants need a recent tumor sample for study entry and cannot have active autoimmune diseases or other serious health issues.

What is being tested?

The trial is testing Domvanalimab alone and combined with Zimberelimab in patients with advanced solid malignancies. It's an early-phase study to check safety, how the body processes the drugs (PK/PD), and their effects on cancer.

What are the potential side effects?

As this is a Phase 1 trial primarily assessing safety and tolerability, specific side effects are not listed but may include typical reactions to immunotherapy such as fatigue, skin reactions, inflammation-related symptoms in various organs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose date to date of death, up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose date to date of death, up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose date to date of death, up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0

Secondary study objectives

AB154 Peak Plasma Concentration (Cmax)

Disease Control Rate

Domvanalimab Area Under the Plasma Concentration Versus Time Curve (AUC)

+9 more

Other study objectives

Receptive aphasia (finding)

Domvanalimab Cytokines

Domvanalimab Gene Expression

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

6Treatment groups

Experimental Treatment

Group I: Fixed dose Domvanalimab Q3W or Q4W and Zimberelimab Q3W, Q4WExperimental Treatment2 Interventions