All studies
Active not recruitingPHASE1INTERVENTIONAL

A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors

This study is a ‘first-in-human’ trial, meaning it's the first time this new medicine, called GSK3745417, is being given to people. It's for adults with advanced cancers that haven't responded to other treatments. The researchers want to find out if the new medicine is safe and how well people tolerate it, both when given on its own and when combined with an existing cancer drug called dostarlimab. They also aim to work out the best dose to use and see if it shows any early signs of helping to control the cancer. This knowledge is important for potentially developing new ways to treat cancer in the future.

At a glance

Status
Active not recruiting
Phase
PHASE1
Sponsor
GlaxoSmithKline
Enrolment target
97
Start
12 Mar 2019
Estimated completion
31 Mar 2026

Results

Results from this study

Posted January 2026

Results have been published for this study.

Primary outcome
Part 1A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 Alone (Q1W)
AE is DLT if deemed clinically relevant,attributed to study intervention \& met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR\>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue\<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0
Full results on the registry

What is this study about?

This study is a very early-stage trial looking at a new medicine called GSK3745417. It's often called a 'first-in-human' study because it's the first time this drug is being given to people, rather than just tested in labs. The main goals are to make sure the medicine is safe, to understand any side effects people might experience (this is called 'tolerability'), and to find the best dose to give.

The study will also explore if this new medicine can show any early signs of helping people with advanced cancers. It will do this in two ways: by giving GSK3745417 on its own to some participants, and by giving it alongside another cancer medicine called dostarlimab to others. Taking part in such an early study helps doctors learn a lot about new treatments, which can then lead to further research and potentially new treatment options for different cancers.

This research focuses on people whose advanced cancers are no longer responding to standard treatments, or who can't take those treatments. Early studies like this are crucial steps in finding new ways to fight cancer, by carefully testing new drugs to see how they work in the human body. The information gathered here will guide future, larger studies.

Key takeaways

  • This is an early study of a new cancer medicine, GSK3745417.
  • It's for adults with advanced solid cancers that haven't responded to other treatments.
  • The study aims to find a safe dose and look for early signs of effectiveness.
  • The new medicine will be given alone or with another drug, dostarlimab.
  • Close monitoring for safety and side effects will be a key part of participating.

Who may be eligible?

This study is for adults aged 18 or over who have advanced or recurring solid cancers. This means their cancer has either spread, returned, or hasn't responded to other available treatments. To join, your cancer must be a 'solid tumor' (not a blood cancer) and doctors need to be able to measure it using scans.

There are also some important health requirements. You need to be generally well enough to take part, meaning you can mostly look after yourself and do light activities. Organ functions like your liver need to be working properly. You'll also need to have a recent tissue sample (biopsy) taken to help doctors understand your cancer better.

However, some conditions would mean you can't join. For example, if you have certain active autoimmune diseases, a history of serious bleeding problems, or specific heart conditions. Also, if you have an active infection needing treatment, or have certain liver or bowel conditions, you wouldn't be able to participate. Women must not be pregnant or breastfeeding and, if they could become pregnant, must use effective contraception.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have a solid cancer that is advanced or has come back after previous treatments?
  3. Are you generally well and able to look after yourself?
  4. Are you prepared to have a new tissue sample (biopsy) taken?
  5. Do you *not* have certain serious health conditions, especially recent severe infections, heart problems, or active autoimmune diseases?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the new medicine GSK3745417, either by itself or along with dostarlimab. Both medicines are given through a drip (intravenous infusion). The study starts with a 'dose escalation' phase, which means participants will receive gradually increasing doses of the medicine to find the safest and most effective amount. You will have regular visits to the hospital for checks, which will include blood tests, urine tests, physical exams, and scans (like CT scans) to see how the cancer is responding. You will also be asked to provide a fresh tissue sample (biopsy) before starting treatment. The total duration of your participation will depend on how you respond to the treatment and the study plan, but it will involve regular hospital visits and follow-up for a period of time.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit is that you might be among the first to receive a new treatment that could help your cancer, especially if other treatments haven't worked. However, there's no guarantee the treatment will be effective for you. Potential risks include experiencing side effects from the study medicines, which can range from mild to serious, and some may not yet be known as this is a new drug. You will be closely monitored by the study team for any side effects. Remember, joining is completely voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

  • GSK Investigational Site
    Verified postcode
    Houston, United States
  • GSK Investigational Site
    Verified postcode
    Melbourne, Australia
  • GSK Investigational Site
    Verified postcode
    Toronto, Canada
  • GSK Investigational Site
    Verified postcode
    Bordeaux, France
  • GSK Investigational Site
    Verified postcode
    Villejuif, France
  • GSK Investigational Site
    Verified postcode
    Tokyo, Japan
  • GSK Investigational Site
    Verified postcode
    Tokyo, Japan
  • GSK Investigational Site
    Verified postcode
    Amsterdam, Netherlands
  • GSK Investigational Site
    Verified postcode
    Amsterdam, Netherlands
  • GSK Investigational Site
    Verified postcode
    Seoul, South Korea
  • GSK Investigational Site
    Verified postcode
    Barcelona, Spain
  • GSK Investigational Site
    Verified postcode
    Madrid, Spain

Common questions

What kind of cancer is this study for?

This study is for people with advanced or recurring solid cancers which haven't responded to other standard treatments.

What is a 'first-in-human' study?

It means this is the very first time this new medicine is being given to people, so doctors are learning a lot about it for the first time.

Will I get the new drug alone or with another medicine?

Some participants will receive the new drug alone, and others will receive it with another cancer medicine called dostarlimab.

What is a 'biopsy'?

A biopsy is a small sample of tissue taken from your body, usually from the cancer, to be looked at under a microscope.

Can I leave the study once I've started?

Yes, you can choose to leave the study at any point, and it won't affect your future medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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