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NCT02723955 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1)
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 829
- Enrollment target
NCT02723955: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT02723955 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 829 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1282% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02723955, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 829 participants
- Enrollment target
Study 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.
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involve medical
Interventions
- DRUG Pembrolizumab
- DRUG Docetaxel
- DRUG Pemetrexed
- DRUG GSK3174998
- DRUG feladilimab (GSK3359609)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 829 participants |
| Start Date | 2016-06-23 |
| Est. Completion | 2023-07-05 |
| Phase | Phase 1 |
What the finished NCT02723955 record still lists
NCT02723955 is an interventional study that assigns participants to a tested intervention. The registered 829 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1282% higher).
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT02723955 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02723955 about?
NCT02723955 is a clinical study titled "Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1)". 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...
What is the current status of trial NCT02723955?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 829 participants. The study started on 2016-06-23. Estimated completion is 2023-07-05.
What interventions are being tested in trial NCT02723955?
The interventions under investigation include: Pembrolizumab (DRUG), Docetaxel (DRUG), Pemetrexed (DRUG), GSK3174998 (DRUG), feladilimab (GSK3359609) (DRUG).
Who is sponsoring clinical trial NCT02723955?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02723955's enrollment target sits among peer trials
829 12th of 2000 higher than 1,989 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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