24 completed, 8 unknown, 2 terminated, 2 withdrawn. 23 Phase 1, 16 Phase 2, 2 Not applicable, 2 Phase 3.
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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 |
|---|---|---|---|---|---|---|
| Clinical Trial of Efepoetin Alfa in Healthy Subjects Efepoetin Alfa - Healthy | Phase 1 | Completed | Genexine, Inc. | 40 | 2024-10-29 | 2025-08-21 |
| A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis Efepoetin Alfa, Darbepoetin Alfa - Anemia of Chronic Kidney Disease | Phase 3 | Recruiting | Genexine, Inc. | 429 | 2024-01-25 | 2026-05-22 |
| Trial of the Combination of GX-188E Vaccination, GX-I7 and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 and/or 18 Positive Head and Neck Cancer GX-188E, GX-I7, Pembrolizumab, GX-188E, Pembrolizumab, GX-188E, GX-I7 - Head and Neck Squamous Cell Carcinoma | Phase 2 | Active not recruiting | Yonsei University | 56 | 2022-03-01 | 2026-02-09 |
| 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 |
| Evaluation of Efficacy, Safety and Immunogenicity of GX-19N in Healthy Individuals Who Have Received COVID-19 Vaccines GX-19N, Placebo - SARS-CoV2 Infection | Phase 2 / Phase 3 | Withdrawn | Genexine, Inc. | 2021-10-01 | 2022-04-12 | |
| 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 |
| Safety and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Elderly Individuals GX-19N - SARS-CoV-2 | Phase 1 | Completed | Genexine, Inc. | 30 | 2021-02-16 | 2024-03-01 |
| Safety and Immunogenicity Study of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Adults GX-19N, Placebo - SARS-CoV-2 | Phase 1 / Phase 2 | Completed | Genexine, Inc. | 185 | 2020-12-30 | 2025-08-20 |
| 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 |
| Safety and Tolerability of GX-P1 in Healthy Male Volunteers GX-P1 or Placebo (dose level 1), GX-P1 or Placebo (dose level 2), GX-P1 or Placebo (dose level 3) - Autoimmune Diseases | Phase 1 | Completed | Genexine, Inc. | 24 | 2020-08-11 | 2021-07-27 |
| Safety and Immunogenicity Study of GX-19, a COVID-19 Preventive DNA Vaccine in Healthy Adults GX-19, Saline - SARS-CoV-2 | Phase 1 / Phase 2 | Terminated | Genexine, Inc. | 60 | 2020-06-17 | 2025-08-20 |
| 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 | |
| A Phase 2, 12-Week, Double-Blind, Efficacy and Safety of GX-G6 in Patients With Uncontrolled Type 2 Diabetes Mellitus GX-G6, Control - Type 2 Diabetes Mellitus | Phase 2 | Unknown | Genexine, Inc. | 78 | 2019-06-01 | 2019-05-23 |
| 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 |
| The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer GX-188E, KEYTRUDA® - Cervical Cancer | Phase 1 / Phase 2 | Completed | Genexine, Inc. | 65 | 2018-06-19 | 2025-07-30 |
| 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 |
| Tolerability, Safety and Pharmacokinetics Study of GX-30 in Total Thyroidectomy or Near Total Thyroidectomy Patients Period 1 GX-30, Period 2 THYROGEN®, Period 1 THYROGEN®, Period 2 GX-30 - Total Thyroidectomy, Near-total Thyroidectomy | Phase 1 / Phase 2 | Completed | Genexine, Inc. | 8 | 2017-09-07 | 2020-09-09 |
| Safety and Tolerability of GX-G6 in Healthy Male Subjects Gx-G6, Placebo - Diabetes Mellitus | Phase 1 | Completed | Genexine, Inc. | 48 | 2017-08-31 | 2018-08-29 |
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Uterine Cervical Dysplasia (6) · COVID-19 (3) · Hepatitis B, Chronic (3) · Dwarfism, Pituitary (2) · Glioblastoma (2) · Papillomavirus Infections (2) · Acquired Immunodeficiency Syndrome (1) · Anemia (1) · Autoimmune Diseases (1) · Breast Neoplasms (1) · Chronic Disease (1) · DNA Virus Infections (1) · Diabetes Mellitus (1) · Diabetes Mellitus, Type 2 (1) · Genital Diseases, Female (1)
efineptakin alfa (13) · GX-188 vaccine (5) · GX-19N vaccine (3) · pembrolizumab (3) · Cyclophosphamide (2) · Darbepoetin alfa (2) · GC1113 (2) · GX-H9 (2) · Human Growth Hormone (2) · entecavir (2) · Antiretroviral Therapy, Highly Active (1) · Bevacizumab (1) · Imiquimod (1) · Saline Solution (1) · Sodium Chloride (1)
South Korea (34) · Indonesia (2) · Ukraine (2) · Armenia (1) · Bulgaria (1) · Czechia (1) · Estonia (1) · Georgia (1) · Germany (1) · Italy (1) · Poland (1) · Serbia (1) · Taiwan (1) · Turkey (Türkiye) (1)
JungWon Woo, Ph.D. (3) · Minkyu Heo (3) · Jun Yong Choi, MD (2) · Aira Peri, MD (1) · Byung Chul Shin, MD (1) · Chi-Heum Cho, M.D. (1) · Cho Chi-heum, M.D. (1) · Chul-Woo Yang, MD (1) · Eun Jig Lee, MD, PhD (1) · Eun Young Seong, MD (1) · Howard Lee, M.D, Ph.D. (1) · Hye Ryun Kim (1) · Hyun-Tak Jin, ph.D. (1)
PMID 42012895, PMID 32339447, PMID 33271094, PMID 35156068, PMID 38330377, PMID 39823099, PMID 40490502