What is the mechanism of action of this treatment?

Immune checkpoint inhibitors, such as Anti-PD-1 monoclonal antibodies, work by blocking proteins that inhibit the immune system's ability to attack cancer cells. This mechanism allows T-cells to better recognize and destroy cancer cells. For solid tumor patients, this is significant because it leverages the body's natural immune response to target and eliminate tumors, providing a promising alternative to conventional treatments like chemotherapy.

What side effects are associated with this type of intervention?

Treatments for solid tumors, particularly immune checkpoint inhibitors like Anti-PD-1 Monoclonal Antibodies, commonly cause immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Severe toxicities can include grade 3 or higher events like severe pneumonitis and colitis. Chemotherapy, often combined with these agents, typically results in side effects such as nausea, vomiting, fatigue, myelosuppression, and increased infection risk. Both treatment types can lead to significant toxicities that require careful management.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of solid tumors. Notable approvals include pembrolizumab (Keytruda) and nivolumab (Opdivo), both of which target the PD-1 pathway. Pembrolizumab has been approved for various cancers, including melanoma, non-small cell lung cancer (NSCLC), and head and neck squamous cell carcinoma. Nivolumab has similar approvals and is also used in combination with ipilimumab (Yervoy), an anti-CTLA-4 antibody, for enhanced efficacy in certain cancers. These treatments work by enhancing the immune system's ability to fight cancer cells, similar to the investigational combination of GS-4528 and Anti-PD-1 Monoclonal Antibody.

What other types of research exist?

Promising novel alternatives for solid tumor treatment in 2024 include: 1) Pembrolizumab plus chemotherapy, which has shown efficacy in metastatic non-small-cell lung cancer (NSCLC) as per the KEYNOTE-189 study. 2) Nivolumab plus ipilimumab, which has demonstrated benefits in various cancers including melanoma and renal cell carcinoma. 3) Cabozantinib, a tyrosine kinase inhibitor, which has shown activity in ROS1 fusion-positive NSCLC. 4) Atezolizumab plus bevacizumab, which has been effective in metastatic renal cell carcinoma. These therapies offer different mechanisms of action and have been validated in clinical trials.

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Virus Therapy

Zimberelimab for Solid Cancers

Phase 1

Recruiting

Research Sponsored by Gilead Sciences

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 predose on day 1 and post dose up to eot (up to 24 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, GS-4528, alone or with an immune therapy in people with advanced solid tumors. The goal is to see if it is safe and to find the best dose. The combination aims to help the immune system fight cancer more effectively.

Who is the study for?

Adults with advanced solid tumors who have tried all other treatments without success or can't tolerate them are eligible for this trial. They must be physically capable of daily activities (ECOG status 0 or 1), have measurable disease, proper organ function, and agree to use contraception if applicable. Those with autoimmune diseases, active second cancers, CNS metastases, significant heart issues, serious infections including HIV/HBV/HCV, lung conditions like pneumonitis, symptomatic fluid accumulation in the body cavities, recent vaccinations or pregnancy are excluded.

What is being tested?

The study is testing GS-4528 alone and combined with an Anti-PD-1 Monoclonal Antibody to see if they're safe and tolerable for treating solid tumors. It aims to find the highest dose patients can take without severe side effects (MTD/MAD) and recommend a Phase 2 dose (RP2D).

What are the potential side effects?

Potential side effects include immune system reactions that could affect various organs leading to inflammation-related symptoms; these may range from mild discomforts such as fatigue to more serious conditions requiring medical attention.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose on day 1 and post dose up to eot (up to 24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose on day 1 and post dose up to eot (up to 24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose on day 1 and post dose up to eot (up to 24 months) for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

PK parameter: AUC of GS-4528 as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody

PK parameter: Cmin of GS-4528 as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody

Pharmacokinetic (PK) parameter: Cmax of GS-4528 as Monotherapy and in Combination With Anti-PD-1 Monoclonal Antibody

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase 1b:Dose Escalation of GS-4528 in Combination With Anti-PD-1 Monoclonal Antibody (zimberelimab)Experimental Treatment2 Interventions

Participants will receive escalating doses of GS-4528 in combination with anti-PD1 monoclonal antibody (zimberelimab) to determine the maximum tolerated dose of GS-4528 as a combination therapy.

Group II: Phase 1a: GS-4528 Monotherapy Dose ExpansionExperimental Treatment1 Intervention

Participants will receive GS-4528 monotherapy at the dose determined in the escalation phase.

Group III: Phase 1a: GS-4528 Monotherapy Dose EscalationExperimental Treatment1 Intervention

Participants will receive escalating doses of GS-4528 monotherapy to determine the maximum tolerated dose.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zimberelimab

2019

Completed Phase 2

~300

Do I qualify?Apply below to find out

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

Immune checkpoint inhibitors, such as Anti-PD-1 monoclonal antibodies, work by blocking proteins that inhibit the immune system's ability to attack cancer cells. This mechanism allows T-cells to better recognize and destroy cancer cells. For solid tumor patients, this is significant because it leverages the body's natural immune response to target and eliminate tumors, providing a promising alternative to conventional treatments like chemotherapy.

Immune evasion and current immunotherapy strategies in mycosis fungoides (MF) and Sézary syndrome (SS).Emerging and mechanism-based therapies for recurrent or metastatic Merkel cell carcinoma.