6 completed, 3 terminated, 3 unknown, 1 active not recruiting. 11 Phase 1, 5 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 11 | Completed 6, Terminated 3, Unknown 1, Withdrawn 1 |
| Phase 2 | 5 | Unknown 2, Active not recruiting 1, Completed 1, Withdrawn 1 |
Follow GX-I7: new trials by email Literature Review of GX-I7 trials Research Report on GX-I7
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma Biospecimen Collection, Efineptakin alfa, Pembrolizumab - High Grade Astrocytic Tumor, Recurrent Glioblastoma, IDH-Wildtype | Phase 2 | Active not recruiting | Mayo Clinic | 53 | 2023-01-24 | 2026-10-05 |
| Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC. SL-T10, GX-I7, Pembrolizumab - Metastatic Castration-resistant Prostate Cancer (mCRPC) | Phase 1 | Unknown | SL VAXiGEN | 78 | 2022-10-17 | 2024-04-03 |
| NT-I7 for Kaposi Sarcoma in Patients With or Without HIV Efineptakin alfa - AIDS-Related Kaposi Sarcoma, HIV Infection | Phase 1 | Terminated | Fred Hutchinson Cancer Center | 8 | 2022-05-23 | 2024-06-27 |
| GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients GX-I7, Bevacizumab - Recurrent Glioblastoma | Phase 2 | Unknown | Genexine, Inc. | 20 | 2022-01-26 | 2023-06-12 |
| Safety and Preliminary Efficacy Study of GX-I7 in Patients With COVID-19 GX-I7, GX-I7 vehicle - Covid19 | Phase 1 | Terminated | Genexine, Inc. | 10 | 2021-03-24 | 2022-11-30 |
| NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery Efineptakin alfa - Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma | Phase 1 | Terminated | Hyunseok Kang, MD | 4 | 2021-03-12 | 2025-02-14 |
| A Study to Evaluate the Safety and Efficacy of GX-I7 in Elderly Patients With Asymptomatic or Mild Symptoms of COVID-19 GX-I7 - Covid19 | Phase 2 | Unknown | PT Kalbe Genexine Biologics | 210 | 2020-11-01 | 2021-03-24 |
| Efficacy and Safety Study of GX-I7 Plus Adjuvant Temozolomide Combination in Patients With Newly Diagnosed Glioblastoma GX-I7, Placebo - Newly Diagnosed Glioblastoma | Phase 1 / Phase 2 | Withdrawn | Genexine, Inc. | 2019-08-22 | 2022-03-17 | |
| Study of GX-I7 in Combination With Pembrolizumab in Refractory or Relapsed (R/R) TNBC Subjects(GX-I7-CA-006/KEYNOTE-899) GX-I7, Pembrolizumab(KEYTRUDA®), Cyclophosphamide - Triple Negative Breast Cancer | Phase 1 / Phase 2 | Completed | Genexine, Inc. | 84 | 2019-03-27 | 2024-03-05 |
| GX-I7 With Cyclophosphamide in Patients With Metastatic or Recurrent Solid Tumors GX-I7, Cyclophosphamide - Solid Tumor | Phase 1 | Completed | Genexine, Inc. | 24 | 2018-10-17 | 2020-05-14 |
| Dose-escalation Study to Evaluate the Safety and Tolerability of GX-I7 in Patients With Glioblastoma GX-I7 - Newly Diagnosed Glioblastoma | Phase 1 | Completed | Genexine, Inc. | 15 | 2018-06-20 | 2020-11-10 |
| Study to Evaluate Safety and Tolerability of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors GX-I7 - Locally Advanced or Metastatic Solid Tumors | Phase 1 | Completed | Genexine, Inc. | 35 | 2018-03-05 | 2020-05-11 |
| Safety and Tolerability of GX-I7 in HPV-infected Female Volunteers GX-I7, Placebo - Human Papillomavirus | Phase 1 | Completed | Genexine, Inc. | 32 | 2017-02-16 | 2018-10-23 |
| Clinical Trial of GX-I7 in Healthy Volunteers GX-I7, Placebo - Healthy | Phase 1 | Completed | Genexine, Inc. | 30 | 2016-07-11 | 2018-10-23 |
| Individual Patient Compassionate Use of GX-I7 GX-I7 - Glioblastoma, High Grade Glioma | No longer available | Genexine, Inc. | 2022-03-17 |
Glioblastoma (3) · COVID-19 (2) · AIDS-related Kaposi sarcoma (1) · Breast Neoplasms (1) · Glioma (1) · Gliosarcoma (1) · HIV Infections (1) · Melanoma (1) · Sarcoma, Kaposi (1) · Squamous Cell Carcinoma of Head and Neck (1) · Triple Negative Breast Neoplasms (1)
Genexine, Inc. (10) · Fred Hutchinson Cancer Center (1) · Hyunseok Kang, MD (1) · Mayo Clinic (1) · PT Kalbe Genexine Biologics (1) · SL VAXiGEN (1)
South Korea (11) · United States (3) · Indonesia (1)
Minkyu Heo (3) · Chang Wook Jeong, MD, phD (1) · Cheol Kwak, MD, phD (1) · Howard Lee, M.D, Ph.D. (1) · Hyunseok Kang, MD (1) · Jae Kwan Lee, MD, PhD (1) · Jian L. Campian, MD, PhD (1) · Joo Hyuk Sohn, MD (1) · Myoung-Ah Lee, MD (1) · Tae Won Kim, MD (1)
PMID 42012895, PMID 32339447, PMID 39915263, PMID 40490502
R01CA288862 (1), UM1CA154967 (1)