Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Aug 29, 2024
  • participants needed
    178
  • sponsor
    GlaxoSmithKline
Updated on 6 May 2022
measurable disease
primary cancer
solid neoplasm

Summary

This first-time-in-human (FTIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of escalating doses of GSK6097608 given as monotherapy and in combination with dostarlimab in participants with advanced solid tumors. In addition, dostarlimab will be given as monotherapy and in combination with GSK6097608 and with GSK4428859A (EOS884448) in Japanese and Chinese participants. Drug name mentioned as GSK4428859A and EOS884448 are interchangeable for the same compound. In the rest of the document, the drug will be referred to as GSK4428859A (EOS884448).

Details
Condition Neoplasms
Treatment dostarlimab, GSK6097608, GSK4428859A (EOS884448)
Clinical Study IdentifierNCT04446351
SponsorGlaxoSmithKline
Last Modified on6 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults 18 years of age or older (or >=20 years of age in Arm-A Japan, Arm-D Japan, Arm E-Japan, and Arm F-Japan)
Female participants of childbearing potential must agree to use a highly effective form of contraception
Histological or cytological documentation of locally advanced, recurrent, or metastatic solid malignancy
Disease that has progressed after standard therapy for the specific tumor type, or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate, or if no further standard therapy exists
Participants in a PK/PD cohort must provide a tumor biopsy during the screening period from a tumor lesion and agree to an additional on-treatment biopsy
Measurable disease per RECIST 1.1
Eastern cooperative oncology group (ECOG) performance status (PS) 0 to 1
Life expectancy of at least 12 weeks
Adequate organ function as determined by laboratory assessments
Adequate cardiac ejection fraction as measured by echocardiogram
Arm A-Japan, Arm D-Japan, Arm E-Japan, and Arm F-Japan only: lives in Japan and is racially Japanese, defined as all biological grandparents being Japanese
Arm A-China, Arm B-China, Arm D-China, Arm E-China and Arm F-China only: is of Chinese descent and lives in China
Arm D, Arm E, and Arm F only: has been deemed suitable for assigned treatment based on assessment by the investigator

Exclusion Criteria

Prior anti-cancer treatment including investigational agents, immune checkpoint inhibitors, chemotherapy, targeted therapy, and biological therapy: within 4 weeks or 5 half-lives of the drug, whichever is shorter
Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation
Known additional malignancy that progressed or required active treatment within the last 2 years
Uncontrolled or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
Toxicity from previous anticancer treatment, including; greater than or equal to Grade 3 immune-mediated toxicity considered related to prior immunotherapy and that led to treatment discontinuation; or toxicity related to prior treatment that has not resolved; or myocarditis of any grade considered related to prior immuno-oncology therapy that led to treatment discontinuation
Active autoimmune disease that has required systemic disease-modifying or immunosuppressive treatment within the last 2 years
Concurrent medical condition requiring the use of systemic immunosuppressive treatment
Cirrhosis or current unstable liver or biliary disease per investigator assessment
Active infection requiring systemic treatment, known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
History or evidence of significant cardiovascular (CV) risk
Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions
Prolonged QT as measured by electrocardiogram
History of idiopathic pulmonary fibrosis; interstitial lung disease; organizing pneumonia; noninfectious pneumonitis that required steroids, or evidence of active, noninfectious pneumonitis
Pregnant or lactating woman
Allergen desensitization therapy within 4 weeks of starting study intervention
Receipt of live vaccine within 30 days of the start of study intervention
History of hypersensitivity to any of the study interventions or their excipients
Receipt of transfusion of blood products or administration of colony-stimulating factors within 14 days before the first dose of study intervention
Major surgery less than 4 weeks before the first dose of study intervention
Known drug or alcohol abuse
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note