GS-9716 for Solid Malignancies

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sarah Cannon Research Institute, Nashville, TN
Solid Malignancies+1 More
GS-9716 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug can be safely given to people with cancer.

See full description

Eligible Conditions

  • Solid Malignancies

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether GS-9716 will improve 3 primary outcomes and 10 secondary outcomes in patients with Solid Malignancies. Measurement will happen over the course of First dose date up to 21 days.

Approximately 2 years
Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) for GS-9716
Maximum Observed Concentration (Cmax) for GS-9716
Time to Maximum Observed Concentration (Tmax) for GS-9716
Month 39
Parts B and C: Progression-Free Survival (PFS)
Month 39
Parts B and C: Overall Survival (OS)
Week 105
Parts B and C: Time to Response (TTR)
Day 21
Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Week 105
Percentage of Participants Experiencing Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), Version 5.0
Percentage of Participants Experiencing Laboratory Abnormalities According to NCI CTCAE, Version 5.0
Month 37
Parts B and C: Duration of Response (DOR)
Up to 105 weeks
Parts B and C: Confirmed ORR
Parts B and C: Disease Control Rate (DCR)
Parts B and C: Objective Response Rate (ORR)

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

12 Treatment Groups

Part C (Cohort C3): GS-9716 + Docetaxel
1 of 12
Part B (Cohort B5): GS-9716 + Docetaxel + Gemcitabine
1 of 12
Part A: GS-9716 Dose-Expansion
1 of 12
Part A: GS-9716 Dose-Escalation
1 of 12
Part B (Cohort B3): GS-9716 + Docetaxel
1 of 12
Part B (Cohort B2): GS-9716 + Sacituzumab Govitecan-hziy
1 of 12
Part C (Cohort C1): GS-9716 + Docetaxel
1 of 12
Part B (Cohort B1): GS-9716 + Docetaxel
1 of 12
Part C (Cohort C2): GS-9716 + Sacituzumab Govitecan-hziy
1 of 12
Part C (Cohort C5): GS-9716 + Docetaxel + Gemcitabine
1 of 12
Part C (Cohort C4): GS-9716 + Sacituzumab Govitecan-hziy
1 of 12
Part B (Cohort B4): GS-9716 + Sacituzumab Govitecan-hziy
1 of 12
Experimental Treatment

This trial requires 205 total participants across 12 different treatment groups

This trial involves 12 different treatments. GS-9716 is the primary treatment being studied. Participants will be divided into 12 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Part C (Cohort C3): GS-9716 + DocetaxelParticipants with metastatic TNBC will receive combination of GS-9716 and docetaxel.
Part B (Cohort B5): GS-9716 + Docetaxel + GemcitabineParticipants with metastatic STS with nonspecific histologies will receive combination of GS-9716, docetaxel and gemcitabine.
Part A: GS-9716 Dose-Expansion
Drug
Participants will receive the MTD or below MTD of GS-9716.
Part A: GS-9716 Dose-Escalation
Drug
Participants will receive escalating doses of GS-9716 to establish MTD.
Part B (Cohort B3): GS-9716 + DocetaxelParticipants with metastatic TNBC will receive combination of GS-9716 and docetaxel.
Part B (Cohort B2): GS-9716 + Sacituzumab Govitecan-hziyParticipants with non-squamous metastatic NSCLC will receive combination of GS-9716 and sacituzumab govitecan-hziy.
Part C (Cohort C1): GS-9716 + DocetaxelParticipants with non-squamous metastatic NSCLC will receive combination of GS-9716 and docetaxel.
Part B (Cohort B1): GS-9716 + DocetaxelParticipants with non-squamous metastatic NSCLC will receive combination of GS-9716 and docetaxel.
Part C (Cohort C2): GS-9716 + Sacituzumab Govitecan-hziyParticipants with non-squamous metastatic NSCLC will receive combination of GS-9716 and sacituzumab govitecan-hziy.
Part C (Cohort C5): GS-9716 + Docetaxel + GemcitabineParticipants with metastatic STS with nonspecific histologies will receive combination of GS-9716, docetaxel and gemcitabine.
Part C (Cohort C4): GS-9716 + Sacituzumab Govitecan-hziyParticipants with metastatic TNBC will receive combination of GS-9716 and sacituzumab govitecan-hziy.
Part B (Cohort B4): GS-9716 + Sacituzumab Govitecan-hziyParticipants with metastatic TNBC will receive combination of GS-9716 and sacituzumab govitecan-hziy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
FDA approved
Gemcitabine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly approximately 2 years for reporting.

Closest Location

Sarah Cannon Research Institute - Nashville, TN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Castrate-resistant prostate cancer that is not receiving hormonal androgen deprivation therapy is a group of cancers that no longer responds to treatment with drugs or surgery to remove the testicles. show original
is a cancer that affects the colon and rectum show original
is the most common form of thyroid cancer show original
is the most common cancer in women show original
Part A: GS-9716 Monotherapy
is a cancer that starts in the cervix show original
Endometrial cancer
Epithelial ovarian cancer
is a type of cancer that affects the esophagus show original
Gastric or gastroesophageal junction adenocarcinoma

Patient Q&A Section

What is cancer?

"Cancer is any abnormality in tissue that, if left untreated, can grow and invade surrounding normal tissue and eventually spread elsewhere in the body. There are many types of cancer, but most have in common the production of growth signals which lead to the uncontrolled division of cells. Most cancers have a combination of two characteristics, an uncontrolled division of cells and the formation of new blood vessels supplying the growing mass with oxygen and nutrients that it needs. These grow into tumor masses, which can eventually metastasise. The development of cancer remains a mystery as to where the cancer develops from, but is believed to arise from a combination of genetic, nutritional, environmental and aging factors." - Anonymous Online Contributor

Unverified Answer

How many people get cancer a year in the United States?

"Each year, approximately 8 million US adults will be diagnosed with cancer. This makes cancer the leading cause of disease-related deaths for adults in the US. On average, 3.0% (1.2 million) of American adults will die of cancer. Cancer is also a major component of morbidity and mortality for adults, accounting for 20.4% (22.9 million) of hospitalizations, 39% (34.5 million) of outpatient visits requiring treatment, and 20.0% of lifetime earnings lost due to cancer. On average, 1." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer?

"This article discusses signs associated with cancers where it is often not immediately visible. It also provides clues to what may be on the horizon. Although a diagnosis remains possible for some, one sign alone is often not sufficient to exclude a cancer, especially when others might also be present." - Anonymous Online Contributor

Unverified Answer

What causes cancer?

"Cancers can be formed when certain genetic abnormalities occur. There are several underlying causes. Most cancers are associated with specific cancers, but some are linked to an accumulation of multiple cancers, or with a type of cancer. In the most common types of cancers which are the subject of this article, some can be prevented by reducing high risk behaviors, eating a healthy diet, and staying physically active.\n" - Anonymous Online Contributor

Unverified Answer

Can cancer be cured?

"There currently is no cure for cancer at this stage of technological development. However, cancer is often treatable with a high rate of cure if discovered early." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer?

"The medical oncologists who treat solid tumors have a wide variety of opinions and preferences in their treatment. We think that patients/patients should be involved in this discussion because their treatment decisions can have huge impacts on survival and quality of life as well as on the cost of disease care. Although homeopathy has not shown to have positive results in cancer, it is recommended as it is an effective treatment for many specific diseases such as cough, diarrhea, hepatitis etc. and also it does not worsen the symptom. It is possible that a homeopathic doctor would prescribe a homeopathic remedy to help treat an illness, but we need to know more about that." - Anonymous Online Contributor

Unverified Answer

Does cancer run in families?

"Results from a recent paper of this study provide further evidence for a familial pattern to cancer in an area where cancer is not rare." - Anonymous Online Contributor

Unverified Answer

How serious can cancer be?

"Most common causes of death among cancer patients are cardiovascular diseases and lung cancer. If the disease is left untreated, it does not always lead to immediate death, but it doesn't need to be ignored." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of cancer?

"Although the number of primary factors cannot be narrowed down to a single cause, the majority of cancers seem to have at least one primary factor. Some cancers are multifactorial; for example, colorectal cancer has multiple factors as do many cancers of the bladder and lung. Some of the factors that have been associated are age, smoking, infections through microbes, diet, and genetics. More research is needed to determine whether there is an overall causative agent beyond any single factor as to a single cause of cancer." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating cancer?

"None. The only new treatments for cancer were radiation therapy and cryosurgery. All these treatments had already been known a decade ago and used successfully. All existing treatments for cancer are more or less the same." - Anonymous Online Contributor

Unverified Answer

What is gs-9716?

"The most common adverse event (and the top reason for discontinuation) was nausea. The most common (and most expensive) side effect (and the top reason for discontinuation) was fatigue. Because of these adverse effects (almost 50% of people discontinued gs-9716), the sponsor expects that further pharmacology studies, studies more tailored to the unique pharmacologic profile of gs-9716, and/or trials of the next generation of drugs will be necessary before the drug continues development." - Anonymous Online Contributor

Unverified Answer

Is gs-9716 safe for people?

"While the study was not randomized, and there was no placebo control group there were no known patients who received chemotherapy and survived. It is not safety that should be questioned. Further the results of the study were comparable with those of a number of randomization controlled trials." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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