Clinical trial NCT02723955: Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1)
Official title: A Phase I Open Label Study of GSK3359609 Administered Alone and in Combination With Anticancer Agents in Subjects With Selected Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: ICOS receptor agonist antibody
Pembrolizumab
KEYNOTE-478
GSK3359609
Cohort expansion
Dose escalation
Dostarlimab
Cobolimab
Bintrafusp alfa
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2016-03-31
Enrollment: 829
Sex: ALL
Minimum age (years): 18
Maximum age (years): 93
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody intended for the treatment of cancers of different histology. This is a first-time-in-human (FTIH), open-label, multicenter study designed to investigate the safety, pharmacology, and preliminary antitumor activity in participants with selected, advanced or recurrent solid tumors with the aim to establish recommended dose(s) of GSK3359609 for further exploration as monotherapy and in combination with pembrolizumab or chemotherapy regimens. The study is comprised of two primary parts, each composed of two phases: Part 1: GSK3359609 monotherapy with Part 1A as dose escalation phase and Part 1B as cohort expansion phase; Part 2: GSK3359609 combination therapy with Part 2A pembrolizumab or GSK3174998 or chemotherapy or pembrolizumab plus chemotherapy or dostarlimab plus cobolimab or Bintrafusp alfa combination dose escalation phase and Part 2B expansion phase with pembrolizumab. The primary objective of the study is to determine the safety, tolerability, maximum tolerated dose or the maximum administered dose of GSK3359609 alone or in combination.


Eligibility criteria: Inclusion Criteria

* Capable of giving signed, written informed consent.
* Male or female, age 18 to 93 years (at the time consent is obtained).
* Histological or cytological documentation of an invasive malignancy that was diagnosed as locally advanced/metastatic or relapsed/refractory and is of one of the following tumor types: bladder/urothelial cancer of the upper and lower urinary tract; cervical; colorectal (includes appendix); esophagus, squamous cell; head and neck carcinoma; melanoma; malignant pleural mesothelioma (MPM); non-small-cell lung cancer (NSCLC), prostate; Microsatellite Instability-High/deficient mismatch repair (MSI-H/dMMR) tumor (Part 1B and Part 2B) and Human Papilloma Virus (HPV)-positive or Epstein-Barr (EBV)-positive tumor (Part 1B and Part 2B).
* 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; exceptions are in these tumor types in which pembrolizumab single agent may be a standard: NSCLC, head and neck squamous cell cancer (HNSCC), bladder/urothelial cancer, MSI-H/dMMR cancers and melanoma and cervical cancer. In Part 2B pembrolizumab combination expansion cohorts, prior treatment with anti-Programmed cell death protein 1(PD-1)/ Ligand-1 (L1) may not be required. 1) Participants must not have received more than 5 prior lines of therapy for advanced disease including both standards of care and investigational therapies. 2) Participants who received prior PD-1/L1 therapy must fulfill the following requirements (Part 1B \[except PK/PD cohort\]/ Part 2B):a) Have achieved a CR, PR or SD and subsequently had disease progression while still on PD-1/L1 therapy; b) Have received at least 2 doses of an approved PD-1/L1 inhibitor (by any regulatory authority), c) Have demonstrated disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 within 18 weeks from the last dose of the PD-1/L1 inhibitor. The initial evidence of disease progression is to be confirmed by a second assessment no less than four weeks from the date of the first documented Progressive Disease (PD) (the confirmatory scan could be the Baseline eligibility scan for this study). 3) In Part 2A 5-fluorouracil (FU)/platinum combination with GSK3359609 and pembrolizumab cohort, participants must not have received prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy given as part of multimodal treatment for locally advanced disease).
* Archival tumor tissue obtained at any time from the initial diagnosis to study entry; a fresh tumor biopsy using a procedure that is safe for the participant on a lesion not previously irradiated unless lesion progressed will be required if archival tissue is unavailable.
* Agree to undergo a pre-treatment and on treatment biopsy and have disease amenable to biopsy required in pharmacokinetic (PK) / pharmacodynamics (PD), dose randomized HNSCC, Melanoma dose expansion and Biomarker cohorts..
* Measurable disease per RECIST version 1.1. Palpable lesions that are not measurable by radiographic or photographic evaluations may not be utilized as the only measurable lesion. Any measurable lesion biopsied at Screening cannot be followed as a target/index lesion unless agreed upon by GlaxoSmithKline (GSK).
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
* Life expectancy of at least 12 weeks.
* Adequate organ function.
* QT interval corrected for heart rate according to Fridericia's formula (QTcF) \<450 milliseconds (msec) or QTcF \<480 msec for participants with bundle branch block.
* A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum beta-human chorionic gonadotrophin \[beta-hCG\] test in females of reproductive potential), and not lactating or reproductive potential agrees to follow one of the options listed in protocol from 30 days prior to the first dose of study medication and until 120 days after the last dose of study treatment.
* Male participants with female partners of child bearing potential must agree to use one of the methods of contraception specified in protocol from time of first dose of study treatment until 120 days after the last dose of study treatment.
* Documented HPV/ EBV-positive tumor as determined by a local laboratory for Part 1B and Part 2B pembrolizumab combination viral-positive expansion cohorts only.
* Documented MSI-H or dMMR-positive tumor as determined by local laboratory for Part 1B and Part 2B pembrolizumab combination MSI-H/dMMR expansion cohorts only.
* ICOS expression result using an analytically validated immunohistochemistry (IHC) assay by central laboratory for Part 1B biomarker cohort only.
* Gene expression (GEX) result using an analytically validated method by central laboratory (Part 1B Biomarker Cohort only).
* PD-L1 combined positive score (CPS) \<1 using the Food and Drug Administration (FDA) approved PD-L1 IHC 22C3 pharmdx assay by central laboratory testing for Part 2B HNSCC PD-L1 CPS \<1 Cohort. Documented test result from FDA approved PD-L1 IHC 22C3 pharmDx assay in local laboratory, if available, may be accepted in lieu of the central laboratory test result.

Exclusion Criteria

* Prior treatment with the following therapies:

Â• Anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug is administered.

Â• Part 2B (GSK3359609/pembrolizumab combination): prior pembrolizumab washout is not required.

Â• Prior radiation therapy: permissible if at least one 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. A wash out of at least two weeks before start of study drug for radiation of any intended use to the extremities for bone metastases and 4 weeks for radiation to the chest, brain, or visceral organs is required. Â• Investigational therapy within 30 days or 5 half-lives of the investigational product (whichever is shorter). At least 14 days must have elapsed between the last dose of investigational agent and the first dose of study drug is administered.

* Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.
* Toxicity from previous anticancer treatment
* Invasive malignancy or history of invasive malignancy other than disease under study within the last two years except: Any other invasive malignancy for which the participant was definitively treated, has been disease-free for \<=2 years and in the opinion of the principal investigator and GSK Medical Monitor will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy, may be included in this clinical trial; and curatively treated non-melanoma skin cancer.
* Central nervous system (CNS) metastases, with the following exception: Â• Participants who have previously-treated CNS metastases, are asymptomatic, and have no requirement for steroids at least 14 days prior to first dose of study drug. Participants with carcinomatous meningitis or leptomeningeal spread are excluded regardless of clinical stability.
* Received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor \[G-CSF\], granulocyte-macrophage colony-stimulating factor, recombinant erythropoietin) within 14 days prior to the first dose of GSK3359609.
* Major surgery \<=4 weeks 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.
* Active autoimmune disease that has required systemic treatment within the last two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Concurrent medical condition requiring the use of systemic immunosuppressive medications within 7 days before the first dose of study treatment. Physiologic doses of corticosteroids for treatment of endocrinopathies or steroids with minimal systemic absorption, including topical, inhaled, or intranasal corticosteroids may be continued if the participant is on a stable dose.
* Condition requiring treatment with strong inhibitors/inducers of cytochrome p (CYP) 450 3A4 within 7 days prior to first dose of chemotherapy (requirement applies to participants enrolled to Part 2 chemotherapy combination with docetaxel).
* Active infection requiring systemic therapy, known human immunodeficiency virus infection, or positive test for hepatitis B active infection or hepatitis C active infection.
* Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per investigator assessment).
* Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction that required surgery.
* Receipt of any live vaccine within 4 weeks prior to first dose of study treatment.
* Recent history of allergen desensitization therapy within 4 weeks of starting study treatment.
* History of severe hypersensitivity to monoclonal antibodies or to the chemotherapies under investigation including any ingredient used in the formulation.
* History or evidence of cardiac abnormalities.
* History of (current and past) idiopathic pulmonary fibrosis, pneumonitis (for past pneumonitis exclusion only if steroids were required for treatment), interstitial lung disease, or organizing pneumonia. Note: post-radiation changes in the lung related to prior radiotherapy and/or asymptomatic radiation-induced pneumonitis not requiring treatment may be permitted if agreed by the investigator and Medical Monitor.
* Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions.
* Any serious and/or unstable pre-existing medical, psychiatric disorder, or other condition that could interfere with the participant's safety, obtaining informed consent, or compliance to the study procedures.

Primary outcomes:
measure: Part 1A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)
timeFrame: Up to approximately 367 weeks
measure: Part 1A: Number of Participants With Dose Limiting Toxicity (DLT)
timeFrame: Up to 28 days
measure: Part 1A: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
timeFrame: Baseline (Day 1) and up to approximately 367 weeks
measure: Part 1A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
timeFrame: Up to approximately 367 weeks
measure: Part 1A: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
timeFrame: Baseline (Day 1) and up to approximately 367 weeks
measure: Part 1A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
timeFrame: Up to approximately 367 weeks
measure: Part 1A: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
timeFrame: Up to approximately 367 weeks
measure: Part 1A: Number of Participants With Dose Modifications of Feladilimab
timeFrame: Up to approximately 367 weeks
measure: Part 2A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)
timeFrame: Up to approximately 367 weeks
measure: Part 2A: Number of Participants With Dose Limiting Toxicity (DLT)
timeFrame: Up to 28 days
measure: Part 2A: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
timeFrame: Baseline (Day 1) and up to approximately 367 weeks
measure: Part 2A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
timeFrame: Up to approximately 367 weeks
measure: Part 2A: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
timeFrame: Baseline (Day 1) and up to approximately 367 weeks
measure: Part 2A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
timeFrame: Up to approximately 367 weeks
measure: Part 2A: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
timeFrame: Up to approximately 367 weeks
measure: Part 2A: Number of Participants With Dose Modifications of Feladilimab
timeFrame: Up to approximately 367 weeks
Secondary outcomes:
measure: Part 1B: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)
timeFrame: Up to approximately 367 weeks
measure: Part 1B: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
timeFrame: Baseline (Day 1) and up to approximately 367 weeks
measure: Part 1B: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
timeFrame: Up to approximately 367 weeks
measure: Part 1B: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
timeFrame: Baseline (Day 1) and up to approximately 367 weeks
measure: Part 1B: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
timeFrame: Up to approximately 367 weeks
measure: Part 1B: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
timeFrame: Up to approximately 367 weeks
measure: Part 1B: Number of Participants With Dose Modifications of Feladilimab
timeFrame: Up to approximately 367 weeks
measure: Part 2B: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)
timeFrame: Up to approximately 367 weeks
measure: Part 2B: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
timeFrame: Baseline (Day 1) and up to approximately 367 weeks
measure: Part 2B: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
timeFrame: Up to approximately 367 weeks
measure: Part 2B: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
timeFrame: Baseline (Day 1) and up to approximately 367 weeks
measure: Part 2B: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
timeFrame: Up to approximately 367 weeks
measure: Part 2B: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
timeFrame: Up to approximately 367 weeks
measure: Part 2B: Number of Participants With Dose Modifications of Feladilimab
timeFrame: Up to approximately 367 weeks
measure: Part 1A: Overall Response Rate (ORR)
timeFrame: Up to approximately 367 weeks
measure: Part 1A: Disease Control Rate (DCR)
timeFrame: Up to approximately 367 weeks
measure: Part 1A: Overall Survival (OS)
timeFrame: Up to approximately 367 weeks
measure: Part 1A: Progression-free Survival (PFS)
timeFrame: Up to approximately 367 weeks
measure: Part 1A: Time to Overall Response (TTR)
timeFrame: Up to approximately 367 weeks
measure: Part 1A: Duration of Response (DOR)
timeFrame: Up to approximately 367 weeks
measure: Part 2A: Overall Response Rate (ORR)
timeFrame: Up to approximately 367 weeks
measure: Part 2A: Disease Control Rate (DCR)
timeFrame: Up to approximately 367 weeks
measure: Part 2A: Overall Survival (OS)
timeFrame: Up to approximately 367 weeks
measure: Part 2A: Progression-free Survival (PFS)
timeFrame: Up to approximately 367 weeks
measure: Part 2A: Time to Overall Response (TTR)
timeFrame: Up to approximately 367 weeks
measure: Part 2A: Duration of Response (DOR)
timeFrame: Up to approximately 367 weeks
measure: Part 1B: Overall Response Rate (ORR)
timeFrame: Up to approximately 367 weeks
measure: Part 1B: Disease Control Rate (DCR)
timeFrame: Up to approximately 367 weeks
measure: Part 1B: Overall Survival (OS)
timeFrame: Up to approximately 367 weeks
measure: Part 1B: Progression-free Survival (PFS)
timeFrame: Up to approximately 367 weeks
measure: Part 1B: Time to Overall Response (TTR)
timeFrame: Up to approximately 367 weeks
measure: Part 1B: Duration of Response (DOR)
timeFrame: Up to approximately 367 weeks
measure: Part 2B: Overall Response Rate (ORR)
timeFrame: Up to approximately 367 weeks
measure: Part 2B: Disease Control Rate (DCR)
timeFrame: Up to approximately 367 weeks
measure: Part 2B: Overall Survival (OS)
timeFrame: Up to approximately 367 weeks
measure: Part 2B: Progression-free Survival (PFS)
timeFrame: Up to approximately 367 weeks
measure: Part 2B: Time to Overall Response (TTR)
timeFrame: Up to approximately 367 weeks
measure: Part 2B: Duration of Response (DOR)
timeFrame: Up to approximately 367 weeks
measure: Part 1A: Maximum Observed Plasma Concentration (Cmax) and Minimum Observed Plasma Concentration (Ctau) of Feladilimab
timeFrame: Pre-dose; end of infusion (EOI); 0.5, 1, 2, 4, 6, 8, 24, 48-72, 96-120 hours POST EOI; week 1; week 2; Pre-dose and 0.5 hours POST EOI in week 3; week 4; week 5; Pre-dose and 0.5 hours POST EOI in week 6, 9, 12 15; Pre-dose in week 21 and 33
measure: Part 1A: Area Under the Concentration-time Curve From Time 0 to 504 Hours After Dosing [AUC (0-504h)] of Feladilimab
timeFrame: Pre-dose; end of infusion (EOI); 0.5, 1, 2, 4, 6, 8, 24, 48-72, 96-120 hours post-EOI; week 1; week 2; Pre-dose and 0.5 hours post-EOI in week 3; week 4; week 5; Pre-dose and 0.5 hours post-EOI in week 6, 9, 12 15; Pre-dose in week 21 and 33
measure: Part 2A: Ctau of Pembrolizumab
timeFrame: Pre-dose and 24 hours post-EOI on day 1; week 1; week 2; Pre-dose in week 3; week 4; week 5; Pre-dose in week 9, 15, 18, 21, 33, 45, 57, 69, 81 and 93
measure: Part 2A: AUC (0-504h) of Pembrolizumab
timeFrame: Pre-dose and 24 hours post-EOI on day 1; week 1; week 2; Pre-dose in week 3; week 4; week 5; Pre-dose in week 9, 15, 18, 21, 33, 45, 57, 69, 81 and 93
measure: Part 2A: Cmax and Ctau of GSK3174998
timeFrame: Pre-dose and 24 hours post-EOI on day 1; week 1; week 2; Pre-dose in week 3; week 4; week 5; Pre-dose in week 9, 15, 18, 21, 33, 45, 57, 69, 81 and 93
measure: Part 2A: AUC (0-504 h) of GSK3174998
timeFrame: Pre-dose and 24 hours post-EOI on day 1; week 1; week 2; Pre-dose in week 3; week 4; week 5; Pre-dose in week 9, 15, 18, 21, 33, 45, 57, 69, 81 and 93
measure: Part 1B: Cmax and Ctau of Feladilimab
timeFrame: Pre-dose; end of infusion (EOI); 0.5, 1, 2, 4, 6, 8, 24, 48-72, 96-120 hours post-EOI; week 1; week 2; Pre-dose and 0.5 hours post-EOI in week 3; week 4; week 5; Pre-dose and 0.5 hours post-EOI in week 6, 9, 12 15; Pre-dose in week 21, 33 and 45
measure: Part 1B: AUC (0-504 h) of Feladilimab
timeFrame: Pre-dose; end of infusion (EOI); 0.5, 1, 2, 4, 6, 8, 24, 48-72, 96-120 hours post-EOI; week 1; week 2; Pre-dose and 0.5 hours post-EOI in week 3; week 4; week 5; Pre-dose and 0.5 hours post-EOI in week 6, 9, 12 15; Pre-dose in week 21, 33 and 45
measure: Part 2B: Cmax and Ctau of Feladilimab
timeFrame: Pre-dose; EOI; 0.5, 1, 2, 4, 6, 8, 24, 48-72, 96-120 hours post-EOI; week 1; week 2; Pre-dose and 0.5 hours post-EOI in week 3; week 4; week 5; Pre-dose and 0.5, 4 hours post-EOI in week 6, 9, 12 and15; Pre-dose in week 18, 21, 33, 45, 57, 69, 81 and 93
measure: Part 2B: AUC (0-504 h) of Feladilimab
timeFrame: Pre-dose; EOI; 0.5, 1, 2, 4, 6, 8, 24, 48-72, 96-120 hours post-EOI; week 1; week 2; Pre-dose and 0.5 hours post-EOI in week 3; week 4; week 5; Pre-dose and 0.5, 4 hours post-EOI in week 6, 9, 12 and15; Pre-dose in week 18, 21, 33, 45, 57, 69, 81 and 93
measure: Part 2B: AUC (0-1008 h) of Feladilimab
timeFrame: Pre-dose; EOI; 0.5, 1, 2, 4, 6, 8, 24, 48-72, 96-120 hours post-EOI; week 1; week 2; Pre-dose and 0.5 hours post-EOI in week 3; week 4; week 5; Pre-dose and 0.5, 4 hours post-EOI in week 6, 9, 12 and15; Pre-dose in week 18, 21, 33, 45, 57, 69, 81 and 93
measure: Part 2B: Cmax and Ctau of Pembrolizumab
timeFrame: Pre-dose; EOI; 0.5, 1, 2, 4, 6, 8, 24, 48-72, 96-120 hours post-EOI; week 1; week 2; Pre-dose and 0.5 hours post-EOI in week 3; week 4; week 5; Pre-dose and 0.5, 4 hours post-EOI in week 6, 9, 12 and15; Pre-dose in week 18, 21, 33, 45, 57, 69, 81 and 93
measure: Part 2B: AUC (0-504h) of Pembrolizumab
timeFrame: Pre-dose; EOI; 0.5, 1, 2, 4, 6, 8, 24, 48-72, 96-120 hours post-EOI; week 1; week 2; Pre-dose and 0.5 hours post-EOI in week 3; week 4; week 5; Pre-dose and 0.5, 4 hours post-EOI in week 6, 9, 12 and15; Pre-dose in week 18, 21, 33, 45, 57, 69, 81 and 93
measure: Part 1A: Number of Participants With Positive Results in Anti-drug Antibody (ADA) Test by Feladilimab Dose Level
timeFrame: Up to approximately 367 weeks
measure: Part 2A: Number of Participants With Positive Results in ADA Test by Feladilimab in Combination With GSK3174998 Dose Level
timeFrame: Up to approximately 367 weeks
measure: Part 2A: Number of Participants With Positive Results in ADA Test by Feladilimab Dose Level in Combination With Pembrolizumab
timeFrame: Up to approximately 367 weeks
measure: Part 2A: Number of Participants With Positive Results in ADA in Pembrolizumab
timeFrame: Up to approximately 367 weeks
measure: Part 2A: Number of Participants With Positive Results in ADA in GSK3174998
timeFrame: Up to approximately 367 weeks
measure: Part 2A: Number of Participants With Positive Results in ADA Test by Feladilimab Combination With Chemotherapies Dose Level
timeFrame: Up to approximately 367 weeks
measure: Part 1B: Number of Participants With Positive Results in ADA Test by Feladilimab Dose Level
timeFrame: Up to approximately 367 weeks
measure: Part 2B: Number of Participants With Positive Results in ADA Test by Feladilimab Dose Level
timeFrame: Up to approximately 367 weeks
measure: Part 2B: Number of Participants With Positive Results in ADA in Pembrolizumab
timeFrame: Up to approximately 367 weeks
measure: Part 1A: Receptor Occupancy of Feladilimab
timeFrame: Up to approximately 367 weeks
measure: Part 2A: Receptor Occupancy of Feladilimab
timeFrame: Up to approximately 367 weeks
measure: Part 1B: Receptor Occupancy of Feladilimab
timeFrame: Up to approximately 367 weeks
measure: Part 2B: Receptor Occupancy of Feladilimab
timeFrame: Up to approximately 367 weeks
Other outcomes:
Locations:
city: Duarte
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Sarasota
country: United States
facility: GSK Investigational Site
state: Florida
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Heidelberg
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Shnghai
country: China
facility: GSK Investigational Site
city: Bordeaux Cedex
country: France
facility: GSK Investigational Site
city: Lyon cedex 08
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Villejuif cedex
country: France
facility: GSK Investigational Site
city: Siena
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: MÃ¡ga
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Turner DC, Wada R, Zhou H, Wang X, de Greef R, Valiathan C, Zhang L, Zhang N, Kuchimanchi M, Chen TT, Ballas M, Visser SAG. Model-based meta-analysis of non-small cell lung cancer with standard of care PD-1 inhibitors and chemotherapy for early development decision making. CPT Pharmacometrics Syst Pharmacol. 2023 Nov;12(11):1751-1763. doi: 10.1002/psp4.12917. Epub 2023 Jan 31.