What side effects are associated with this type of intervention?

Common treatments for solid tumors, including immune checkpoint inhibitors like zimberelimab, often have side effects such as fatigue, rash, diarrhea, and pruritus. Severe adverse events can include pneumonitis, colitis, hepatitis, and endocrinopathies. Chemotherapy, another common treatment, frequently causes myelosuppression, leading to neutropenia, anemia, and thrombocytopenia, as well as gastrointestinal symptoms like nausea, vomiting, and mucositis. Targeted therapies may result in specific toxicities depending on the target, such as hypertension, hand-foot syndrome, and cardiotoxicity.

What prior FDA approvals exist?

Several FDA-approved drugs for the treatment of solid tumors include immune checkpoint inhibitors and targeted therapies. Pembrolizumab and nivolumab, both PD-1 inhibitors, have been approved for various solid tumors, including melanoma and non-small cell lung cancer. Additionally, targeted therapies like erlotinib, which inhibits the EGFR pathway, and cabozantinib, a tyrosine kinase inhibitor, have shown efficacy in treating specific solid tumors such as non-small cell lung cancer and medullary thyroid cancer, respectively. These treatments exemplify the types of mechanisms being explored in investigational drugs like GS-1811.

What other types of research exist?

Promising novel alternatives to GS-1811 for solid tumor patients include: <ol> <li>Pembrolizumab (KEYNOTE-189) - Effective in combination with chemotherapy for non-small-cell lung cancer.</li> <li></li> </ol> Atezolizumab (IMpower150) - Used in combination with bevacizumab and chemotherapy for non-small-cell lung cancer. 3. Cabozantinib - Demonstrated activity in medullary thyroid cancer and osteosarcoma. 4. Regorafenib - Shown efficacy in metastatic osteosarcoma. 5. Nivolumab - Effective in combination therapy for esophageal squamous-cell carcinoma and mesothelioma.

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Other

GS-1811 + Zimberelimab for Solid Tumors

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

Individuals with pathologically confirmed select advanced solid tumors. Participants must have received, have been intolerant to, or have been ineligible for all treatment known to confer clinical benefit

Individuals with pathologically confirmed select advanced solid tumors

Must not have

History of intolerance, hypersensitivity, or treatment discontinuation due to severe immune-related adverse events (irAEs) on prior immunotherapy

Live vaccines within 30 days prior to first dose

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 up to end of treatment (24 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called GS-1811 alone and with zimberelimab in patients with advanced solid tumors who have no other treatment options. The study aims to find the safest and most effective dose.

Who is the study for?

Adults with advanced solid tumors who've tried all other treatments without success or can't tolerate them are eligible. They must have measurable disease, be in fair to good physical condition (ECOG 0-2), and agree to use contraception. Tissue samples for testing are required.

What is being tested?

The trial is assessing GS-1811 alone or combined with Zimberelimab to find the safest and most effective doses for treating advanced solid tumors. It's divided into parts: some test GS-1811 solo, others in combination therapy.

What are the potential side effects?

Potential side effects may include immune system reactions, as seen with similar drugs like inflammation of organs or tissues, fatigue, infection risks, and possibly infusion-related reactions.

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 and cannot take or have tried all known beneficial treatments.

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I have been diagnosed with a specific advanced solid tumor.

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I have an advanced solid tumor and cannot take or have tried all known beneficial treatments.

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I have tried or cannot take all known beneficial treatments for my condition.

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I have an advanced solid tumor and cannot take or have tried all known beneficial treatments.

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I can care for myself and am up and about more than 50% 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 had a severe allergic reaction to previous immunotherapy.

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I have not received any live vaccines in the last 30 days.

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I haven't had any cancer treatment within the specified time before starting the study.

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I am not currently receiving any cancer treatments.

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I have never received CCR8 targeted therapy.

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I have an ongoing serious infection that needs IV antibiotics.

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I have a serious heart condition.

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I have active hepatitis B, hepatitis C, or HIV.

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I have had severe lung inflammation or damage not caused by localized treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 up to end of treatment (24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 up to end of treatment (24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to end of treatment (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

Disease control rate (DCR)

Duration of response (DOR)

Objective response rate (ORR) in Part D

+2 more

Side effects data

From 2022 Phase 1 & 2 trial • 35 Patients • NCT03003468

100%

PAIN IN EXTREMITY

67%

HEADACHE

67%

PLATELET COUNT DECREASED

67%

COUGH

67%

SORE THROAT

67%

CONSTIPATION

33%

BACK PAIN

33%

NON-CARDIAC CHEST PAIN

33%

DYSPEPSIA

33%

NEUTROPHIL COUNT DECREASED

33%

EYE DISORDERS - OTHER, SPECIFY

33%

DIZZINESS

33%

DYSPNEA

33%

CHRONIC KIDNEY DISEASE

33%

ORAL PAIN

33%

MYALGIA

33%

PNEUMONITIS

33%

GASTROINTESTINAL DISORDERS - OTHER, SPECIFY

33%

PROTEINURIA

33%

ALLERGIC RHINITIS

33%

FATIGUE

33%

ESOPHAGEAL INFECTION

33%

SINUS PAIN

33%

DIARRHEA

33%

ANOREXIA

33%

HYPERGLYCEMIA

33%

DEPRESSION

33%

GINGIVAL PAIN

33%

NAUSEA

33%

RECURRENT LARYNGEAL NERVE PALSY

33%

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY

33%

CHEST WALL PAIN

33%

EDEMA LIMBS

33%

ABDOMINAL PAIN

100%

80%

60%

40%

20%

Study treatment Arm

Imprime PGG 2 mg/kg

Imprime PGG 4 mg/kg

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: Part F: GS-1811 Monotherapy and In Combination With Zimberelimab In Select Dose and ScheduleExperimental Treatment2 Interventions

Group II: Part E: GS-1811 Monotherapy Dose ExpansionExperimental Treatment1 Intervention

Group III: Part D: GS-1811 + Zimberelimab Dose ExpansionExperimental Treatment2 Interventions

Group IV: Part C: GS-1811 + Zimberelimab Dose EscalationExperimental Treatment2 Interventions

Group V: Part B - Mandatory Paired Tumor BiopsyExperimental Treatment1 Intervention

Group VI: Part A - GS-1811 Dose EscalationExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zimberelimab

2019

Completed Phase 2

~300

0 / 15Eligibility 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 solid tumors often include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but can also affect normal cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular abnormalities in cancer cells, minimizing damage to normal cells. Immunotherapies, including checkpoint inhibitors like anti-PD-1 and anti-CTLA-4 antibodies, enhance the body's immune response against cancer cells. These mechanisms are crucial for solid tumor patients as they offer more precise and potentially less toxic treatment options, improving outcomes and quality of life.

Potential molecular targets for Ewing's sarcoma therapy.Promising novel therapies for the treatment of endometrial cancer.[The handling of anti-cancer drugs in elderly patients].