14 completed, 4 unknown, 3 terminated, 1 not yet recruiting. 15 Phase 1, 11 Phase 2, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 15 | Completed 8, Unknown 4, Recruiting 1, Terminated 1, Withdrawn 1 |
| Phase 2 | 11 | Completed 6, Terminated 2, Not yet recruiting 1, Recruiting 1, Unknown 1 |
| Phase 3 | 2 | Completed 2 |
Follow TH 302: new trials by email Literature Review of TH 302 trials Research Report on TH 302
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 to Test Efficacy of Targeting Hypoxia Combined With ARSI After First-line ARSI Therapy for Castrate Resistant Prostate Cancer Evofosfamide - Castration Resistant Prostate Cancer | Phase 2 | Not yet recruiting | University Health Network, Toronto | 35 | 2026-10-01 | 2026-09-24 |
| A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab Evofosfamide, Zalifrelimab, Balstilimab - Metastatic Prostate Cancer, Metastatic Head and Neck Squamous Cell Carcinoma | Phase 1 / Phase 2 | Recruiting | ImmunoGenesis | 71 | 2025-01-08 | 2025-01-21 |
| Immunotherapy Study of Evofosfamide in Combination With Ipilimumab Evofosfamide, Ipilimumab - Pancreatic Cancer, Melanoma | Phase 1 | Unknown | Threshold Pharmaceuticals | 69 | 2017-05-10 | 2017-10-30 |
| Testing TH-302, in Combination With Preoperative Chemoradiotherapy, in Esophageal Cancer. TH-302, HX4 scan, Carboplatin - Esophageal Cancer | Phase 1 | Withdrawn | Maastricht Radiation Oncology | 2015-12-01 | 2016-04-21 | |
| A Study to Assess the Safety and the Efficacy of the Combination of TH-302 and Sunitinib in Neuroendocrine Pancreatic Tumours TH-302 + Sunitinib - Neuroendocrine Tumors, Pancreatic Neoplasms | Phase 2 | Completed | Grupo Espanol de Tumores Neuroendocrinos | 17 | 2015-05-11 | 2020-07-27 |
| TH-302 in Combination With Bevacizumab for Glioblastoma Bevacizumab, TH-302 - Glioblastoma | Phase 2 | Completed | The University of Texas Health Science Center at San Antonio | 35 | 2015-05-01 | 2020-04-10 |
| A Japanese Trial of TH-302 in Subjects With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma TH-302, Doxorubicin - Soft Tissue Sarcoma | Phase 2 | Terminated | Merck KGaA, Darmstadt, Germany | 6 | 2014-12-10 | 2018-12-14 |
| A Phase 1 TH-302 Mass Balance Trial [14C] TH-302 (Label 1), [14C] TH-302 (Label 2), Unlabeled TH-302 - Solid Tumor | Phase 1 | Completed | Merck KGaA, Darmstadt, Germany | 10 | 2014-02-01 | 2016-06-10 |
| Phase I TH-302 Plus Gemcitabine Plus Nab-Paclitaxel in Pancreatic Cancer TH-302, Nab-paclitaxel, Gemcitabine - Pancreatic Cancer | Phase 1 | Terminated | ImmunoGenesis | 19 | 2014-01-01 | 2025-05-11 |
| A Cardiac Safety Study of TH-302 in Patients With Advanced Solid Tumors TH-302 - Solid Tumors | Phase 1 | Unknown | Threshold Pharmaceuticals | 40 | 2013-11-01 | 2016-06-02 |
| A Phase 2 Biomarker - Enriched Study of TH-302 in Subjects With Advanced Melanoma TH-302 - Metastatic Melanoma | Phase 2 | Terminated | ImmunoGenesis | 11 | 2013-05-01 | 2025-05-11 |
| A Japanese Phase 1 Trial of TH-302 in Subjects With Solid Tumors and Pancreatic Cancer Evofosfamide, Gemcitabine - Solid Tumor, Pancreatic Cancer | Phase 1 | Completed | Merck KGaA, Darmstadt, Germany | 20 | 2013-04-18 | 2018-10-15 |
| Clinical Trial Testing TH-302 in Combination With Gemcitabine in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma TH-302, Gemcitabine, Placebo (5 percent dextrose - D5W) - Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma | Phase 3 | Completed | ImmunoGenesis | 693 | 2012-12-01 | 2025-05-11 |
| Sorafenib Tosylate and Hypoxia-Activated Prodrug TH-302 in Treating Patients With Advanced Kidney Cancer or Liver Cancer That Cannot Be Removed By Surgery hypoxia-activated prodrug TH-302, sorafenib tosylate - Kidney Cancer, Liver Cancer | Phase 1 | Completed | Alliance for Clinical Trials in Oncology | 24 | 2012-05-01 | 2020-02-06 |
| Open-label Study of TH-302 and Dexamethasone With or Without Bortezomib or Pomalidomide in Subjects With Relapsed/Refractory Multiple Myeloma TH-302, TH-302 and Dexamethasone, TH-302 Dose Escalation and Dexamethasone in Combination with Bortezomib - Multiple Myeloma | Phase 1 / Phase 2 | Unknown | Threshold Pharmaceuticals | 98 | 2012-02-01 | 2016-06-02 |
| Dose Escalation Study of Pazopanib Plus TH-302 Pazopanib and TH-302 - Solid Tumors | Phase 1 | Completed | Herbert Hurwitz, MD | 50 | 2011-12-01 | 2017-09-01 |
| A Trial of TH-302 in Combination With Doxorubicin Versus Doxorubicin Alone to Treat Patients With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma TH-302 in Combination with Doxorubicin, Doxorubicin - Soft Tissue Sarcoma | Phase 3 | Completed | Threshold Pharmaceuticals | 640 | 2011-09-01 | 2016-06-02 |
| Safety and Efficacy Study of TH-302 CNS Penetration in Recurrent High Grade Astrocytoma Following Bevacizumab TH-302 preoperative, Placebo, TH-302 (escalating) with bevacizumab 10mg/kg - HIGH GRADE GLIOMA | Phase 2 | Completed | The University of Texas Health Science Center at San Antonio | 28 | 2011-06-01 | 2019-07-24 |
| Dose-Escalation Study of TH-302 in Combination With Sunitinib to Treat Patients With Advanced Renal Cell Carcinoma,Gastrointestinal Stromal Tumors and Pancreatic Neuroendocrine Tumors TH-302 - Advanced Renal Cell Carcinoma, Gastrointestinal Stromal Tumors | Phase 1 | Unknown | Threshold Pharmaceuticals | 58 | 2011-06-01 | 2014-04-21 |
| Study of Hypoxia-Activated Prodrug TH-302 to Treat Advanced Leukemias TH-302 - Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia | Phase 1 | Completed | Threshold Pharmaceuticals | 40 | 2010-06-01 | 2015-05-07 |
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Pancreatic Neoplasms (7) · Hypoxia (4) · Sarcoma (4) · Prostatic Neoplasms (3) · Melanoma (2) · Neoplasm Metastasis (2) · Neuroectodermal Tumors, Primitive (2) · Squamous Cell Carcinoma of Head and Neck (2) · Carcinoma, Hepatocellular (1) · Carcinoma, Non-Small-Cell Lung (1) · Carcinoma, Renal Cell (1) · Esophageal Neoplasms (1) · Gastrointestinal Stromal Tumors (1) · Glioblastoma (1) · Glioma (1)
Threshold Pharmaceuticals (8) · ImmunoGenesis (6) · Merck KGaA, Darmstadt, Germany (3) · The University of Texas Health Science Center at San Antonio (2) · Alliance for Clinical Trials in Oncology (1) · Grupo Espanol de Tumores Neuroendocrinos (1) · Herbert Hurwitz, MD (1) · Maastricht Radiation Oncology (1) · Sarcoma Alliance for Research through Collaboration (1) · University Health Network, Toronto (1)
United States (18) · Canada (3) · Germany (3) · Japan (2) · Spain (2) · Austria (1) · Belgium (1) · Denmark (1) · France (1) · Hungary (1) · Israel (1) · Italy (1) · Poland (1) · Russia (1)
Mitesh Borad, MD (2) · Alexander Starodub, MD (1) · Andrew Brenner, MD (1) · Andrew Brenner, MD, (1) · Antonio Gualberto, MD, PhD (1) · David Hong, MD (1) · Enrique Grande, MD (1) · Glen Weiss, MD (1) · Herbert I Hurwitz, MD (1) · Howard Burris, MD (1) · Jeffrey R Infante, MD (1) · Kristen Ganjoo, MD (1) · Lee Cranmer, MD, PhD (1) · Marina Konopleva, MD, PhD (1)
PMID 25512461, PMID 25185097, PMID 25679067, PMID 27535748, PMID 28651927, PMID 34190375
2014 (1), U10CA031946 (1)