Phase 1 First Time in Human (FTIH), Open Label Study of GSK3745417 Administered to Participants With Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    May 22, 2025
  • participants needed
    300
  • sponsor
    GlaxoSmithKline
Updated on 30 June 2022
measurable disease
gilbert's syndrome
metastasis
neutrophil count
liver metastasis
pembrolizumab
EGFR
solid tumor
solid neoplasm
administered intravenously
advanced malignant solid tumor

Summary

This study aims to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of GSK3745417 administered alone (Part 1A) or co-administered (Part 2A) with dostarlimab in participants with refractory/relapsed solid tumors. Both parts will consist of a dose escalation phase.

Details
Condition Neoplasms
Treatment Pembrolizumab, GSK3745417, dostarlimab
Clinical Study IdentifierNCT03843359
SponsorGlaxoSmithKline
Last Modified on30 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant must be more than or equal to (>=)18 years of age
Participants with advanced/recurrent solid tumors, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established
Histological or cytological documentation of an advanced solid tumor
Participants must provide a fresh biopsy
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Adequate organ function per protocol specifications
Male or female participants
Female participants are eligible to participate if they are not breastfeeding or pregnant (or intend to breastfeed or become pregnant). Women of childbearing potential must use a highly effective method of contraception
Capable of giving signed informed consent

Exclusion Criteria

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 within 28 days before the first dose of study treatment
Current unstable liver or biliary disease
QT duration corrected for heart rate by Fridericia's formula (QTcF) more than (>)450 milliseconds (msec) or QTcF >480 msec for participants with bundle branch block
History of vasculitis at any time prior to study treatment
Evidence or history of significant active bleeding or coagulation disorder
Active infection requiring systemic treatment, known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen or hepatitis C
History or evidence of cardiovascular (CV) risk
Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction
History of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia, or evidence of active, non-infectious pneumonitis
Recent history of allergen desensitization therapy within 4 weeks of starting study treatment
Recent (within the past 6 months) history of symptomatic pericarditis
Prior treatment with the following agents
Stimulator of Interferon Genes (STING) agonist at any time
History of (non-infectious) pneumonitis that required steroids or current pneumonitis
Anticancer therapy or investigational therapy or used an investigational device within 28 days or 5 half-lives of the drug, whichever is shorter
Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions
Checkpoint inhibitors, including Programmed death receptor-1 (PD-1), Programmed death Ligand-1 (PD-L1), PD-L2 and Cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitors within 28 days
Prior radiation therapy: permissible if at least 1 non-irradiated measurable lesion is available for assessment according to RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented
Pregnant and/or breast feeding participants or those who plan to become pregnant
and/or breastfeed
Receipt of any live vaccine within 30 days of the start of study treatment
Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation
Major surgery less than or equal to (<=)28 days before the first dose of study treatment. Participants must have also fully recovered from any surgery (major or minor) and/or its complications before initiating study treatment
Participants with signs/symptoms suggestive of Coronavirus Disease-2019 (COVID-19) within 14 days of study entry, or with known exposure to COVID-19 within 14 days prior to study entry
Participants are excluded from Part 2A of the study if they have known hypersensitivity to dostarlimab or associated excipients
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