What side effects are associated with this type of intervention?

Common treatments for solid tumors, including chemotherapeutic agents like gemcitabine and paclitaxel, and targeted therapies, often result in side effects such as neutropenia, anemia, thrombocytopenia, fatigue, neuropathy, diarrhea, and nausea. Immune checkpoint inhibitors can additionally cause hypertension, hypothyroidism, and immune-related adverse events like pneumonitis and rash.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors that involve novel anti-cancer agents and combination therapies. For instance, pembrolizumab, an immune checkpoint inhibitor, has been approved for various solid tumors, including metastatic melanoma and renal cell carcinoma, often in combination with other agents like bevacizumab. Another example is the combination of gemcitabine and pemetrexed for peritoneal mesothelioma. These approvals highlight the trend towards using combination therapies to enhance treatment efficacy in solid tumors.

What other types of research exist?

Promising novel alternatives to GS-9716 for solid tumor patients include LY2090314, a GSK-3 inhibitor that has shown significant growth reduction in neuroblastoma cell lines, and SR18662, a small-molecule inhibitor that has demonstrated efficient growth inhibition of colorectal cancer in both in vitro and in vivo studies.

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GS-9716 + Anticancer Therapies for Advanced 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

Histologically or cytologically confirmed locally advanced or metastatic malignant solid tumor for which no standard therapy is available, standard therapy has failed, or for whom standard-of-care therapy is contraindicated

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

Must not have

Known history of clinically significant cardiovascular disease or heart failure

Uncontrolled pleural effusion, pericardial effusion, or ascites

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first dose date to pd or death, whichever occurs first (up to 39 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug called GS-9716 in patients with advanced solid cancers. The goal is to find the highest safe dose and see if it causes any serious side effects, both alone and with other treatments.

Who is the study for?

Adults with advanced solid tumors who have tried at least one standard treatment or for whom no standard treatment is suitable. They must be in fairly good physical condition (ECOG status of 0 or 1), have a certain level of heart, kidney, and liver function, and cannot have untreated brain metastases or serious health conditions like active hepatitis B/C or autoimmune diseases.

What is being tested?

GS-9716 is being tested alone and alongside other cancer drugs to find the highest dose patients can take without severe side effects. The trial will also look at how well GS-9716 works as a single agent versus when combined with established cancer treatments in people with various types of solid tumors.

What are the potential side effects?

Since this is an early-phase trial to determine safety, specific side effects are not listed but may include typical reactions to cancer therapies such as nausea, fatigue, blood count changes, potential organ inflammation, allergic reactions to the drug infusion, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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My advanced cancer has no standard treatment available, or standard treatments have failed.

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I am fully active or can carry out light work.

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My cancer has returned or didn't respond after 2 treatments, including a taxane.

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My advanced cancer was confirmed by a lab test and cannot be removed by surgery.

Exclusion Criteria

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

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I have a history of serious heart disease or heart failure.

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I do not have uncontrolled fluid buildup in my chest, heart, or abdomen.

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I am not pregnant or breastfeeding.

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I have or had an autoimmune disease or immune deficiency.

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I have previously been treated with sacituzumab govitecan-hziy, a topoisomerase 1 inhibitor, or drugs targeting Trop-2.

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I have heart failure or high heart-related blood markers.

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I am experiencing significant nausea, vomiting, or signs of a blocked intestine.

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I am not taking GS-9716 alone for my condition.

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I haven't needed IV antibiotics in the last 2 weeks.

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I do not have active hepatitis B or C, nor am I HIV positive.

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I have a significant lung condition or active inflammation in my lungs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose date to pd or death, whichever occurs first (up to 39 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose date to pd or death, whichever occurs first (up to 39 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose date to pd or death, whichever occurs first (up to 39 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

Parts B and C: Disease Control Rate (DCR)

Parts B and C: Duration of Response (DOR)

Parts B and C: Objective Response Rate (ORR)

+2 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: Part C (Cohort C4): GS-9716 + sacituzumab govitecan-hziyExperimental Treatment2 Interventions

Patients will receive ≤ MTD GS-9716 in combination with sacituzumab govitecan-hziy.

Group II: Part C (Cohort C1): GS-9716 + docetaxelExperimental Treatment2 Interventions

Patients will receive ≤ MTD GS-9716 in combination with docetaxel.

Group III: Part B (Cohort B4): GS-9716 + sacituzumab govitecan-hziyExperimental Treatment2 Interventions

Patients will receive escalating doses of GS-9716 in combination with sacituzumab govitecan-hziy.

Group IV: Part B (Cohort B1): GS-9716 + docetaxelExperimental Treatment2 Interventions

Patients will receive escalating doses of GS-9716 in combination with docetaxel.

Group V: Part A: GS-9716 Dose-ExpansionExperimental Treatment1 Intervention

Patients will receive ≤ MTD of GS-9716.

Group VI: Part A: GS-9716 Dose-EscalationExperimental Treatment1 Intervention

Patients will receive escalating doses of GS-9716 to estimate MTD.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~6550

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 include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular abnormalities in cancer cells, thereby minimizing damage to normal cells. Immunotherapy, including checkpoint inhibitors like anti-PD-1 and anti-CTLA-4, enhances the body's immune response against cancer cells. These treatments are crucial for solid tumor patients as they offer different mechanisms to control or eliminate cancer, potentially improving survival and quality of life.