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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    873
  • sponsor
    GlaxoSmithKline
Updated on 1 September 2021
Investigator
US GSK Clinical Trials Call Center
Primary Contact
GSK Investigational Site (5.4 mi away) Contact
+29 other location
paclitaxel
combinations
measurable disease
carcinoma
fluorouracil
lung cancer
pemetrexed
carboplatin
gemcitabine
pembrolizumab
pd-l1
docetaxel
primary cancer
solid neoplasm
investigational treatment

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, chemotherapy or other immune therapies. 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 dostarlimab or dostarlimab plus cobolimab or Bintrafusp alfa combination dose escalation phase and Part 2B expansion phase with pembrolizumab. Part 2A GSK3359609 combinations with chemotherapy will only consist of safety run-in cohorts. Each part and phase of the study includes a screening period, a treatment period, and a follow-up period. 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.

Details
Condition Cancer, Cancer/Tumors, Ewing's Family Tumors, Cancer (Pediatric), Neoplasms
Treatment GSK3359609 IV infusion, Pembrolizumab 200 mg IV infusion, Docetaxel 75 milligrams per square meters (mg/m2) IV infusion, Pemetrexed 500 mg/m2 plus Carboplatin area under the curve (AUC) 4-6 mg/mL per minute IV infusion, Paclitaxel 200 mg/m2 plus Carboplatin AUC 4-6 mg/mL per minute IV infusion, Gemcitabine 1250 mg/m2 plus Carboplatin AUC 4-6 mg/mL per minute IV infusion, GSK3174998 IV infusion, Docetaxel 75 milligrams per square meters (mg/m^2) IV infusion, Pemetrexed 500 mg/m^2 plus Carboplatin area under the curve (AUC) 4-6 mg/mL per minute IV infusion, Paclitaxel 200 mg/m^2 plus Carboplatin AUC 4-6 mg/mL per minute IV infusion, Gemcitabine 1250 mg/m^2 plus Carboplatin AUC 4-6 mg/mL per minute IV infusion, Fluorouracil (5-FU) 1000 mg/m^2 plus carboplatin or cisplatin, Bintrafusp Alfa, dostarlimab, Fluorouracil (5-FU) 1000 mg/m^2/day plus carboplatin or cisplatin, Pembrolizumab 400 mg IV infusion, Cobolimab
Clinical Study IdentifierNCT02723955
SponsorGlaxoSmithKline
Last Modified on1 September 2021

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