GSK4381562 for Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
GSK Investigational Site, San Antonio, TX
GSK4381562 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether GSK4381562 will improve 4 primary outcomes and 17 secondary outcomes in patients with Cancer. Measurement will happen over the course of Up to 21 days.

UP to 27 months
Cmin of GSK4381562 in combination with dostarlimab
Up to 21 days
Number of participants with dose-limiting toxicities (DLTs)
Up to 24 months
Number of participants with clinically significant changes in laboratory parameters, electrocardiogram (ECG) and vital signs
Number of participants with dose reductions or delays
Overall response rate (ORR)
Up to 27 months
AUC from time zero to infinity (AUC[0-infinity]) of single dosing of GSK4381562
AUC(0-infinity) of single dosing of GSK4381562 in combination with dostarlimab
AUC(0-t) of GSK4381562 in combination with dostarlimab
Area under the plasma concentration curve from time zero to last time of quantifiable concentration (AUC[0-t]) of GSK4381562
Cmax of GSK4381562 in combination with dostarlimab
Duration of AEs and SAEs
Maximum observed plasma concentration (Cmax) of GSK4381562 monotherapy
Minimum observed plasma concentration (Cmin) of GSK4381562 monotherapy
Number of participants with AEs and SAEs by severity
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Number of participants with positive ADA to dostarlimab
Number of participants with positive antidrug antibodies (ADA) to GSK4381562
Number of participants with withdrawals due to AEs
Titers of ADA to GSK4381562
Titers of ADA to dostarlimab
Up to 4 months
Plasma concentrations of GSK4381562

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

No Control Group
Participants receiving GSK4381562 monotherapy

This trial requires 126 total participants across 2 different treatment groups

This trial involves 2 different treatments. GSK4381562 is the primary treatment being studied. Participants will be divided into 2 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.

Participants receiving GSK4381562 monotherapy
Drug
Participants receiving GSK4381562 plus dostarlimab

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 27 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 27 months for reporting.

Closest Location

GSK Investigational Site - San Antonio, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Cancer. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Is not a woman of childbearing potential (WOCBP) or Is a WOCBP and using a contraceptive method that is highly effective with a failure rate of less than (<)1 percent ([%] per year), during the intervention period and for specified time after end of study treatment.
A WOCBP must have a negative highly sensitive pregnancy test within 24-48 hours before the first dose of study intervention.
head and neck squamous cell carcinoma (HNSCC)
You have non-small-cell lung cancer (NSCLC). show original
You have breast cancer (BC). show original
You have clear cell renal cell cancer. show original
gastric cancer (GC)
colorectal cancer (CRC)
endometrial cancer (EC)
You have ovarian epithelial cancer. show original

Patient Q&A Section

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

What are common treatments for cancer?

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What we do to people with cancer is called “medical treatment” – medical oncologists or MDs, Radiation Oncologists, Radiation Therapists, and Pathologists) – in the U.S., we mostly do surgery, Radiation Oncology, Chemotherapy, and Pathology/histology tests as I have found (but don’t know whether others do the same) some people will be cured, some will be dead within a few years, a majority of them will be dead within five years…If we treat people with cancer, we may even save them and thereby prevent them or their families from feeling as much stress or grief as they will.

Unverified Answer

Can cancer be cured?

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Cancer is generally detected early, when it can be cured with a success rate of over 90%. Most men with stage 4 cancer cannot be cured of their cancer because it can be detected too late. However, many people with cancer can be cured if the cancer is caught early enough.

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

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Over 200,000 patients are diagnosed with cancer each year. theme: survival analysis question: Survival after pancreaticoduodenectomy for benign disease. answer: Survival rates after PD have increased substantially since the 1970s, and PD for benign disease is now well-established procedure often offering prolonged survival.

Unverified Answer

What causes cancer?

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Many cancer cases are caused by environmental, behavioural, biochemical, infectious or genetic factors. Current smoking is the strongest risk factor for most cancers. People of low socio-economic status tend to smoke more intensely, and many cancers have a strong link to diet. Cancer can also be prevented; screening is effective for many common cancers. It is particularly important for women with breast cancer.

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What are the signs of cancer?

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Cancer is a disease wherein the most common sign is a change in a tumour; usually it is an enlarged tumour.\n\n- List of cutaneous conditions"

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What is cancer?

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Approximately 25% of children and teens with cancer have cancer-related symptoms. Symptoms can be a complication or result of treatment and include hair loss, poor appetite, fatigue, and bone pains. Many common cancers can have serious long-term effects on kids and teens and even their lives.\n

Unverified Answer

What is the average age someone gets cancer?

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Cancer incidence, cancer-specific mortality, and overall mortality decreased with increasing age until age 85 years. Most of the decreases were in all-cause mortality, and cancer mortality decreased slightly, irrespective of age, after age 75 years.

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Is gsk4381562 safe for people?

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This clinical investigation has provided consistent and favourable safety and PK results to date confirming that gsk4381562 is acceptable to administer to patients with a variety of different tumour types, in conjunction with paclitaxel. Gsk4381562 does not impair plasma concentration of paclitaxel.

Unverified Answer

Has gsk4381562 proven to be more effective than a placebo?

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As we conclude in the paper, the current study and pooled analysis showed that gsk4381562 is effective in improving symptoms and health-related quality of life and may reduce deterioration of these parameters at the end of life. However, we can also state that the study was not designed to prove efficacy or safety. In order to better understand the clinical efficacy of gsk4381562, it must be compared with some currently available drugs of the same kind of the same purpose as a standard to which to compare (see below).

Unverified Answer

Is gsk4381562 typically used in combination with any other treatments?

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GSK-5381562 exhibited a statistically significant effect modifier when added to FOLFIRINOX chemotherapy alone in the first-line treatment of mCRC. Randomized controlled trials are needed to confirm these findings.

Unverified Answer

Does gsk4381562 improve quality of life for those with cancer?

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These data provide evidence supporting a clinical benefit for gsk4381562 when given over the course of a week in combination with a taxane chemotherapy regimen. Patients’ experience of side effects of gsk4381562 were largely outweighed by their overall improvement in QoL.

Unverified Answer

Have there been other clinical trials involving gsk4381562?

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There is not enough evidence to demonstrate benefit of GSK4381562 in cancer patients. No significant difference in overall survival was noted between treatment and control groups in the study by the FOURS. No conclusive evidence has been found of efficacy or safe use of this drug in cancers with mutations in the p53 gene.

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