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

NCT02723955 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 829

Last updated 2024-12-27

Study results available
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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.

Conditions

  • Neoplasms

Interventions

DRUG

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
93 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-23
Primary Completion
2023-07-05
Completion
2023-07-05
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • China
  • France
  • Italy
  • Japan
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02723955 on ClinicalTrials.gov