GS-1811 for Solid Tumors, Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
NEXT Oncology, San Antonio, TX
Solid Tumors, Advanced Solid Tumors+1 More
GS-1811 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called GS-1811 is safe and tolerable in people with cancer.

See full description

Eligible Conditions

  • Solid Tumors, Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Study Objectives

This trial is evaluating whether GS-1811 will improve 3 primary outcomes and 5 secondary outcomes in patients with Solid Tumors, Advanced Solid Tumors. Measurement will happen over the course of Day 1 Through Day 21.

Day 21
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
Month 24
PK Parameter: Area Under the Concentration-time Curve (AUC) for GS-1811
PK Parameter: Minimum Observed Concentration (Cmin) for GS-1811
PK Parameter: Time of Maximum Observed Concentration (Tmax) for GS-1811
Percentage of Participants who Developed Antidrug Antibody (ADA) Against GS-1811
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for GS-1811
Month 24
Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Percentage of Participants Experiencing Laboratory Abnormalities According to the NCI CTCAE v5.0

Trial Safety

Safety Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Trial Design

3 Treatment Groups

Phase 1b, Part C: GS-1811 + Pembrolizumab
1 of 3
Phase 1a, Part B - Mandatory Paired Tumor Biopsy
1 of 3
Phase 1a, Part A - GS-1811 Dose Escalation
1 of 3
Experimental Treatment

This trial requires 62 total participants across 3 different treatment groups

This trial involves 3 different treatments. GS-1811 is the primary treatment being studied. Participants will be divided into 3 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.

Phase 1b, Part C: GS-1811 + PembrolizumabParticipants will receive GS-1811 at dose levels deemed safe in Part A in combination with pembrolizumab for up to 24 months.
Phase 1a, Part B - Mandatory Paired Tumor Biopsy
Drug
Participants with select tumor types will receive GS-1811 at the dose deemed safe in Part A for up to 12 months.
Phase 1a, Part A - GS-1811 Dose Escalation
Drug
Participants will receive escalating dose levels of GS-1811 for up to 12 months to determine maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) of GS-1811.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 up to end of treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day 1 up to end of treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days for reporting.

Closest Location

NEXT Oncology - San Antonio, TX

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:
Part B: Individuals with select indications who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit
Part B: Must have fresh pre-treatment and on-treatment biopsy for biomarker analysis
Histologically or cytologically confirmed advanced solid tumors
Part A: Individuals with advanced solid tumors who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit
Part C: Individuals with advanced solid tumors who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit or whose disease is indicated for pembrolizumab monotherapy
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
Adequate organ function
Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use methods of contraception
Part A and Part C: Must provide pre-treatment adequate tumor tissue sample prior to enrolment

Patient Q&A Section

What causes cancer?

"Overall cancer is largely caused by lifestyle factors, such as smoking and physical inactivity. More work is needed to develop effective preventative programs for cancer and personalized survivorship care, focusing on individuals who have their own reasons for avoiding exercise." - Anonymous Online Contributor

Unverified Answer

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

"More than 13 million new cases and 4 million cancer deaths occurred in the United States in 2018. The disparity between race and ethnic groups in cancer incidence and mortality has increased significantly." - Anonymous Online Contributor

Unverified Answer

What is cancer?

"Cancer is not just a disease of aging. As life expectancy increases, the number of new cancers diagnosed also increases. There are approximately 2.4 million new cancer diagnoses each year in the US. By age 75, 2 to 3 in 10 will have been diagnosed with cancer. These statistics provide an estimate of the impact of cancer on human life." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer?

"Patients with cancer seek a different kind of help than those with other diagnoses; the kind of help has to address their cancer as well, which was not addressed in this study. The information dissemination needs to be tailored to the preferences of patients and their families." - Anonymous Online Contributor

Unverified Answer

Can cancer be cured?

"Even though the numbers are small, this clinical trial provides evidence that a cure is not likely in those with non-Hodgkin's lymphoma. While this was a very early finding, these results were corroborated by subsequent cohort studies from several countries. In breast cancer, the majority of treatments do not seem to reduce progression of disease, either on an intraprostatic site or on the bones." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer?

"Symptoms and signs of cancer may be subtle and subtlety may be missed by patients and their physicians. It is a dilemma for specialists dealing with this disease and the treatment of cancer. A well-designed clinical history and physical examination are important in making the diagnosis and determining the correct treatment." - Anonymous Online Contributor

Unverified Answer

What does gs-1811 usually treat?

"It is a very early-stage disease based on an assessment of the FDG-PET/CT. The treatment of first-line mTOR inhibitor was very effective regardless of the presence or the location of distant metastases assessed by the FDG-PET/CT. Results from a recent paper suggest that chemotherapy may be an optimal option first-line." - Anonymous Online Contributor

Unverified Answer

Does cancer run in families?

"Although limited numbers of patients in the study were involved in family history assessment, the findings of the current study show that genetic risk factors for cancer in families may be operating, especially for SCC, even in the absence of a familial history." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating cancer?

"There has been a lot of advancement in the past few years in cancer research, however there have been less improvement on how to diagnose cancer sooner with a cure, rather then how to manage it quicker. New treatments have become more effective, but a lot has to be learned before they can be utilized as routine cancer treatment for patients\n" - Anonymous Online Contributor

Unverified Answer

How serious can cancer be?

"The quality of a cancer centre will be a major factor that determines treatment outcomes. Also, the availability of cancer drugs will allow patients with a particular type of cancer receive treatments that may not have been available at any given centre in earlier days. However, it is important to say that there will always be bad news and good news to any patient that is treated here or anywhere in the world." - Anonymous Online Contributor

Unverified Answer

Has gs-1811 proven to be more effective than a placebo?

"Results from a recent clinical trial demonstrates that a 3-week treatment course of the new drug GS-1811 is effective at reducing symptoms of the disorder and in achieving a therapeutic response." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for cancer?

"We propose a system for selection of subjects for trial-based clinical studies which, in addition to conventional assessments of eligibility, takes into account information obtained prior to or during patient recruitment to assess trial risks and benefits." - 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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