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

Part of paid clinical trials in Duarte, California.

Sponsor
GlaxoSmithKline
Study ID
NCT02723955
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - 93 Years
Healthy Volunteers
Not accepted

Interventions

  • feladilimab (GSK3359609) — DRUG
  • GSK3174998 — DRUG
  • Pembrolizumab — DRUG
  • Docetaxel — DRUG
  • Pemetrexed — DRUG
  • Paclitaxel plus Carboplatin — DRUG
  • Gemcitabine plus Carboplatin — DRUG
  • Fluorouracil (5-FU) plus carboplatin or cisplatin — DRUG
  • Dostarlimab — DRUG
  • Cobolimab — DRUG
  • Bintrafusp alfa — DRUG

Study Details

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.

Key Dates

Start date
Jun 23, 2016
Status verified
Nov 2024
Primary completion
Jul 5, 2023
Completion
Jul 5, 2023

Study Design

Enrollment
829 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A: Dose escalation feladilimab (GSK3359609)
    Participants will receive feladilimab (GSK3359609) administered continuously at a dose level dependent on to which dose level the participant is accrued.
  • Experimental: Part 1B: Expansion feladilimab (GSK3359609)
    Participants will receive feladilimab (GSK3359609) administered continuously at a dose level chosen for further exploration in dose expansion cohorts.
  • Experimental: Part 2A: Dose escalation (feladilimab (GSK3359609)+pembrolizumab)
    Participants will receive feladilimab (GSK3359609) administered continuously in combination with pembrolizumab.
  • Experimental: Part 2A: Dose escalation (feladilimab (GSK3359609)+GSK3174998)
    Participants will receive feladilimab (GSK3359609) administered continuously in combination with GSK3174998.
  • Experimental: Part 2A: Safety run-in (feladilimab (GSK3359609)+chemotherapy)
    Participants participating in Part 2A chemotherapy combination cohorts will receive feladilimab (GSK3359609) in combination with chemotherapy at doses and schedules based on standard of care practice.
  • Experimental: Part 2B: Expansion-feladilimab (GSK3359609)
    Participants will receive feladilimab (GSK3359609) administered continuously in combination with pembrolizumab.
  • Experimental: Part 2A: Dose escalation (feladilimab (GSK3359609)+ dostarlimab)
    Participants will receive feladilimab (GSK3359609) administered continuously in combination with dostarlimab.
  • Experimental: Part 2A: Dose escalation (feladilimab (GSK3359609)+dostarlimab+cobolimab)
    Participants will receive feladilimab (GSK3359609) administered continuously in combination with dostarlimab followed by cobolimab.
  • Experimental: Part 2A: Dose escalation (feladilimab (GSK3359609)+bintrafusp alfa)
    Participants will receive feladilimab (GSK3359609) administered continuously in combination with bintrafusp alfa.

Primary Outcome Measure

Part 1A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) [ Time Frame: Up to approximately 367 weeks ]

Locations (9)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteDuarteCalifornia91010-
GSK Investigational SiteLos AngelesCalifornia90025-
GSK Investigational SiteSarasotaFlorida34232-
GSK Investigational SiteNew YorkNew York10016-
GSK Investigational SiteNew YorkNew York10032-
GSK Investigational SiteOklahoma CityOklahoma73104-
GSK Investigational SitePhiladelphiaPennsylvania19111-
GSK Investigational SiteNashvilleTennessee37203-
GSK Investigational SiteNashvilleTennessee37232-6307-

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