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GX-I7

DRUG12 trials

Sponsors

Genexine, Inc., PT Kalbe Genexine Biologics, SL VAXiGEN

Conditions

Advanced CancerCovid19GlioblastomaHealthyHigh Grade GliomaHuman PapillomavirusLocally Advanced or Metastatic Solid TumorsMelanoma

Phase 1

Clinical Trial of GX-I7 in Healthy Volunteers
CompletedNCT02860715
Genexine, Inc.Healthy
Start: 2016-07-11End: 2018-06-02Updated: 2018-10-23
Safety and Tolerability of GX-I7 in HPV-infected Female Volunteers
CompletedNCT03144934
Genexine, Inc.Human Papillomavirus
Start: 2017-02-16End: 2018-03-22Updated: 2018-10-23
Study to Evaluate Safety and Tolerability of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors
CompletedNCT03478995
Genexine, Inc.Locally Advanced or Metastatic Solid Tumors
Start: 2018-03-05End: 2020-03-16Updated: 2020-05-11
Dose-escalation Study to Evaluate the Safety and Tolerability of GX-I7 in Patients With Glioblastoma
CompletedNCT03619239
Genexine, Inc.Newly Diagnosed Glioblastoma
Start: 2018-06-20End: 2020-09-25Updated: 2020-11-10
GX-I7 With Cyclophosphamide in Patients With Metastatic or Recurrent Solid Tumors
CompletedNCT03733587
Genexine, Inc.Solid Tumor
Start: 2018-10-17End: 2020-05-13Updated: 2020-05-14
Study of GX-I7 in Combination With Pembrolizumab in Refractory or Relapsed (R/R) TNBC Subjects(GX-I7-CA-006/KEYNOTE-899)
CompletedNCT03752723
Genexine, Inc.Triple Negative Breast Cancer
Start: 2019-03-27End: 2023-05-11Updated: 2024-03-05
Efficacy and Safety Study of GX-I7 Plus Adjuvant Temozolomide Combination in Patients With Newly Diagnosed Glioblastoma
WithdrawnNCT04065087
Genexine, Inc.Newly Diagnosed Glioblastoma
Start: 2019-08-22End: 2022-08-27Updated: 2022-03-17
Safety and Preliminary Efficacy Study of GX-I7 in Patients With COVID-19
TerminatedNCT04730427
Genexine, Inc.Covid19
Start: 2021-03-24End: 2022-07-07Updated: 2022-11-30
Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC.
RecruitingNCT06344715
SL VAXiGENMetastatic Castration-resistant Prostate Cancer (mCRPC)
Start: 2022-10-17End: 2024-10-31Target: 78Updated: 2024-04-03

Phase 2

A Study to Evaluate the Safety and Efficacy of GX-I7 in Elderly Patients With Asymptomatic or Mild Symptoms of COVID-19
NCT04810637
PT Kalbe Genexine BiologicsCovid19
Start: 2020-11-01End: 2021-09-30Target: 210Updated: 2021-03-24
GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients
NCT05191784
Genexine, Inc.Recurrent Glioblastoma
Start: 2022-01-26End: 2024-12-31Updated: 2023-06-12

Unknown Phase

Individual Patient Compassionate Use of GX-I7
NCT04289155
Genexine, Inc.Advanced Cancer, Glioblastoma, High Grade Glioma +2
Updated: 2022-03-17

Related Papers

Effect of IL7 on ImmTAC-mediated killing by T cells in vitro and T-cell fitness in patients.
Journal of Clinical Oncology2026-05-27
Long-acting IL-7 induces distinct transcriptomic features in peripheral T cells of patients with solid tumors.
2026-04-21
Population Pharmacokinetic and Pharmacodynamic Modeling Analysis of rhIL-7-hyFc, a Hybrid Fc-Fused Long-Acting Interleukin-7, to Support Optimal Dosing Regimens in Patients with Solid Cancer.
2025-10-17
GX-I7, a long-acting IL-7, safely and effectively increased peripheral CD8<sup>+</sup>/CD4<sup>+</sup> T cells and TILs in patients with locally advanced or metastatic solid tumours.
2025-06-093 citations
Expansion of CAR-T Cells in Vivo With Long-Acting Interleukin-7 Analog
Oncology Times2022-08-17
Phase 1b/2 study of GX-I7 plus pembrolizumab in patients with refractory or recurrent (R/R) metastatic triple-negative breast cancer (mTNBC): The KEYNOTE-899 Study.
Journal of Clinical Oncology2022-06-013 citations
322 Efficacy and safety of GX-I7 plus pembrolizumab for heavily pretreated patients with metastatic triple negative breast cancer: The Phase 1b/2 KEYNOTE-899 Study
Regular and Young Investigator Award Abstracts2020-11-012 citations
Preliminary safety and efficacy of GX-I7, a long-acting interleukin-7, in combination with pembrolizumab in patients with refractory or recurrent metastatic triple negative breast cancer (mTNBC): Dose escalation period of Phase Ib/II study (KEYNOTE-899).
Journal of Clinical Oncology2020-05-203 citations
hIL‐7‐hyFc, A Long‐Acting IL‐7, Increased Absolute Lymphocyte Count in Healthy Subjects
Clinical and Translational Science2020-04-2747 citations