Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female participant is not pregnant or breastfeeding
Histological or cytological documentation of loco-regionally recurrent solid tumors or metastatic solid tumors of specific types
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 27 months
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and effective for treating cancer.
Who is the study for?
This trial is for adults with certain advanced solid tumors, like lung, breast, or colorectal cancer, that have worsened after standard treatments or when such treatments aren't suitable. Participants must not be pregnant or breastfeeding and should use effective contraception. They need to have a life expectancy of at least 12 weeks and good organ function.Check my eligibility
What is being tested?
The study tests GSK4381562's safety and effects in humans for the first time. It will also look at how the body processes it (pharmacokinetics) and if it triggers immune responses (immunogenicity). Dostarlimab and GSK4428859A are other interventions under investigation.See study design
What are the potential side effects?
As this is a first-time study, specific side effects of GSK4381562 are unknown but may include typical reactions to cancer immunotherapies such as fatigue, flu-like symptoms, allergic reactions, skin rash or inflammation in organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant or breastfeeding.
Select...
My cancer has returned or spread and is of a specific type.
Select...
My current cancer treatment is not working.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 27 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 27 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Arms A, B, C, D: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Arms A, B, C: Number of participants with dose-limiting toxicities (DLTs)
Secondary outcome measures
AUC from time zero to infinity (AUC[0-infinity]) of single dosing of GSK4381562
AUC(0-infinity) following administration of dostarlimab in combination with GSK4428859A
AUC(0-infinity) of single dosing of GSK4381562 in combination with GSK4428859A
+26 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Participants receiving dostarlimab plus GSK4428859A (Arm D)Experimental Treatment2 Interventions
Group II: Participants receiving GSK4381562 plus dostarlimab plus GSK4428859A (Arm C)Experimental Treatment3 Interventions
Group III: Participants receiving GSK4381562 plus dostarlimab (Arm B)Experimental Treatment2 Interventions
Group IV: Participants receiving GSK4381562 monotherapy (Arm A)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dostarlimab
FDA approved
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,753 Previous Clinical Trials
8,069,526 Total Patients Enrolled
5 Trials studying Tumors
1,919 Patients Enrolled for Tumors
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,768 Total Patients Enrolled
1 Trials studying Tumors
12 Patients Enrolled for Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not able to have children or I am using highly effective birth control.I have colorectal cancer.I have endometrial cancer.I have breast cancer.I have been diagnosed with head and neck cancer.I have ovarian epithelial cancer.I have experienced side effects from previous cancer treatments.I agree to have two tumor biopsies: one before and one 6 weeks after starting treatment.I am not pregnant or breastfeeding.I have another cancer that has worsened or needed treatment in the last 2 years.My organs are functioning well.My side effects from previous treatments have mostly gone away.My cancer has returned or spread and is of a specific type.I have not had certain treatments recently.My current cancer treatment is not working.I am not able to have children or I am using effective birth control.I am fully active or can carry out light work.I haven't taken part in a clinical trial or received any experimental treatments recently.I have had a bone marrow or organ transplant.My condition is non-small-cell lung cancer.I have been diagnosed with gastric cancer.I have clear cell renal cell cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Participants receiving GSK4381562 plus dostarlimab (Arm B)
- Group 2: Participants receiving GSK4381562 monotherapy (Arm A)
- Group 3: Participants receiving GSK4381562 plus dostarlimab plus GSK4428859A (Arm C)
- Group 4: Participants receiving dostarlimab plus GSK4428859A (Arm D)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many clinical locations are administering this trial in the city?
"The current locations offering this treatment are Ottawa, Dallas, San Antonio and an additional five sites. To reduce travel burdens it is recommended to select the closest trial site when enrolling."
Answered by AI
Does GSK4381562 have official sanction from the FDA?
"Due to its Phase 1 status, which implies limited clinical data regarding safety and efficacy, GSK4381562 receives a score of 1."
Answered by AI
How many participants are actively involved in this medical experiment?
"Correct, according to information on clinicaltrials.gov this trial is actively seeking participants. The initial posting for this study was made on March 22nd 2022 and the details were last updated November 18th 2021. They are looking to enlist 162 patients from 5 distinct sites of care."
Answered by AI
Are there any vacancies for participants in this study?
"Affirmative. Clinicaltrials.gov has verified that this experiment, which was made available on March 22nd 2022, is currently seeking applicants. 162 individuals need to be recruited from 5 participating medical facilities."
Answered by AI
Who else is applying?
What state do they live in?
Louisiana
Michigan
Texas
Other
How old are they?
65+
18 - 65
What site did they apply to?
Other
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How responsive is this trial?
Most responsive sites:
- GSK Investigational Site: < 24 hours
Average response time
- < 2 Days
Typically responds via
Email
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger