What side effects are associated with this type of intervention?

Immune checkpoint inhibitors, such as anti-PD-1 antibodies (e.g., nivolumab, pembrolizumab), commonly cause immune-related adverse events (irAEs) including fatigue, rash, diarrhea, and thyroid dysfunction. Severe irAEs can include pneumonitis, hepatitis, colitis, and nephritis, often requiring corticosteroids for management. The investigational agent GS-9911's side effects are not well-documented, but novel agents typically cause gastrointestinal disturbances, fatigue, and hematologic abnormalities.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of solid tumors, particularly anti-PD-1 monoclonal antibodies like nivolumab and pembrolizumab. These drugs have been approved for various cancers, including melanoma, non-small cell lung cancer (NSCLC), and head and neck cancers. They work by enhancing the immune system's ability to fight cancer and have shown significant improvements in overall survival and progression-free survival. Combination therapies involving these agents, such as nivolumab with ipilimumab, have also received FDA approval, offering additional options for patients with advanced solid tumors.

What other types of research exist?

Promising novel alternatives for solid tumor treatment in 2024 include: 1) Combination therapies involving immune checkpoint inhibitors like nivolumab plus ipilimumab, which have shown improved survival rates in various cancers. 2) Targeted therapies such as pembrolizumab combined with chemotherapy, which have demonstrated efficacy in non-small cell lung cancer. 3) Emerging treatments like durvalumab combined with gemcitabine and cisplatin for advanced biliary tract cancer. 4) Novel agents like lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer. These alternatives offer new hope for patients with solid tumors.

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Other

GS-9911 +/− 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

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Be older than 18 years old

Must not have

History of intolerance, hypersensitivity, or treatment discontinuation due to life-threatening immune-related adverse events on prior immunotherapy

Diagnosis of immunodeficiency, or requires systemic corticosteroids (> 10 mg of prednisone daily, or equivalent)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose up to end of treatment (up to 105 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, GS-9911, alone and with another drug that helps the immune system fight cancer, in patients with advanced solid tumors. The goal is to find out if GS-9911 is safe and to determine the best dose to use.

Who is the study for?

Adults with advanced solid tumors who have tried or can't receive other treatments may join. They should be fairly active (ECOG 0-1), have tumors measurable by RECIST v1.1, proper organ function, and agree to provide tissue samples and use contraception if applicable. Excluded are pregnant/lactating women, those with severe reactions to immunotherapy, recent recipients of certain therapies, immune deficiencies or high-dose steroids users, active infections like HBV/HCV/HIV, serious heart conditions or autoimmune diseases.

What is being tested?

The trial is testing GS-9911 alone and combined with Zimberelimab (anti-PD-1 antibody) in adults with advanced solid tumors. It aims to find the safest dose that can be given without causing too many side effects (MTD/MAD) and decide on a recommended dose for further study (RDE).

What are the potential side effects?

Possible side effects include typical reactions related to immune system activation such as fatigue, skin issues, inflammation in various organs including lungs (pneumonitis), potential worsening of autoimmune conditions if pre-existing ones were mild enough not to exclude participation from the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a severe allergic reaction to previous immunotherapy.

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I have an immune system disorder or take more than 10 mg of prednisone daily.

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I have fluid buildup in my abdomen or around my lungs causing symptoms.

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I have had a transplant of tissue or an organ from another person.

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I have cancer that has spread to my brain or spinal cord.

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I have heart problems that cause symptoms.

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I am currently being treated for a serious infection.

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I do not have an active hepatitis B, hepatitis C, or HIV infection.

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I have had lung inflammation treated with steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose up to end of treatment (up to 105 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose up to end of treatment (up to 105 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to end of treatment (up to 105 weeks) 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 (AUC) of GS-9911

PK Parameter: Tmax of GS-9911

Pharmacokinetic (PK) Parameter: Cmax of GS-9911

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part D: Dose Expansion: GS-9911 + Anti-PD-1 Monoclonal AntibodyExperimental Treatment2 Interventions

Participants will receive GS-9911 at RDE determined in Part C in combination with an anti-PD-1 monoclonal antibody (zimberelimab).

Group II: Part C: Dose Escalation: GS-9911 + Anti-PD-1 Monoclonal AntibodyExperimental Treatment2 Interventions

Participants will receive escalating doses of GS-9911 in combination with an anti-PD-1 monoclonal antibody (zimberelimab).

Group III: Part B: GS-9911 Monotherapy Dose ExpansionExperimental Treatment1 Intervention

Participants will receive GS-9911 monotherapy at the recommended dose for expansion (RDE) determined in Part A.

Group IV: Part A: GS-9911 Monotherapy Dose EscalationExperimental Treatment1 Intervention

Participants will receive escalating doses of GS-9911 monotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zimberelimab

2019

Completed Phase 2

~300

0 / 10Eligibility 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

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 recognize and destroy cancer cells more effectively. For solid tumor patients, this is significant because it enhances the body's natural immune response against tumors, providing a promising treatment option for advanced or metastatic disease.

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