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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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 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Systemic infection

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

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

2020

Completed Phase 2

~230

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].