Status:
ACTIVE_NOT_RECRUITING
A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 do...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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.
- 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.
- Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction.
- Recent history of allergen desensitization therapy within 4 weeks of starting study treatment.
- History or evidence of cardiovascular (CV) risk
- Recent (within the past 6 months) history of symptomatic pericarditis.
- History of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia, or evidence of active, non-infectious pneumonitis.
- History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions.
- Prior treatment with the following agents:
- Stimulator of Interferon Genes (STING) agonist at any time.
- Anticancer therapy or investigational therapy or used an investigational device within 28 days or 5 half-lives of the drug, whichever is shorter.
- 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.
Key Trial Info
Start Date :
March 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT03843359
Start Date
March 12 2019
End Date
March 31 2026
Last Update
January 8 2026
Active Locations (13)
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1
GSK Investigational Site
Houston, Texas, United States, 77030
2
GSK Investigational Site
Melbourne, Victoria, Australia, 3000
3
GSK Investigational Site
Toronto, Ontario, Canada, M5G 1Z9
4
GSK Investigational Site
Bordeaux, France, 33076