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

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Updated on 22 April 2022

See if I qualify

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 Identifier	NCT03843359
Sponsor	GlaxoSmithKline
Last Modified on	22 April 2022

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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

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