CompletedPhase 1

Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1)

United States829 participantsStarted 2016-06-23

Plain-language 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.

Who can participate

Age range18 Years – 93 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

What they're measuring

Part 1A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)

Timeframe: Up to approximately 367 weeks

Part 1A: Number of Participants With Dose Limiting Toxicity (DLT)

Timeframe: Up to 28 days

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

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

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

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

Part 1A: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline

Timeframe: Up to approximately 367 weeks

Trial details

NCT IDNCT02723955

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-05

Results submitted2024-07-04

View on ClinicalTrials.gov More Neoplasms trials

Plain-language summary

Who can participate

Age range18 Years – 93 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part 1A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)

Timeframe: Up to approximately 367 weeks

Part 1A: Number of Participants With Dose Limiting Toxicity (DLT)

Timeframe: Up to 28 days

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

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

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

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

Part 1A: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline

Timeframe: Up to approximately 367 weeks