Evofosfamide

Overview

TH-302 is a novel cancer therapeutic specifically activated under the low oxygen or "hypoxic" conditions typical of solid tumor cancer cells. TH-302 is a nitroimidazole-linked prodrug of a brominated derivative of an isophosphoramide mustard previously used in cancer drugs such as ifosfamide, cyclophosphamide, and glufosfamide. TH-302 has been shown, in preclinical studies, to be both efficacious and well tolerated.

Indication

Investigated for use/treatment in solid tumors.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Clinical Trial to Test Efficacy of Targeting Hypoxia Combined With ARSI After First-line ARSI Therapy for Castrate Resistant Prostate Cancer	2025/03/25	NCT06836726	Phase 2	Not yet recruiting	University Health Network, Toronto
A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab	2025/01/20	NCT06782555	Phase 1	Recruiting	ImmunoGenesis
Immunotherapy Study of Evofosfamide in Combination With Ipilimumab	2017/03/31	NCT03098160	Phase 1	UNKNOWN	Threshold Pharmaceuticals
SARC021C: A Continuation Study of TH-CR-406/SARC021	2016/03/18	NCT02712567	N/A	NO_LONGER_AVAILABLE	Sarcoma Alliance for Research through Collaboration
Testing TH-302, in Combination With Preoperative Chemoradiotherapy, in Esophageal Cancer.	2015/11/06	NCT02598687	Phase 1	Withdrawn	Maastricht Radiation Oncology
TH-302 in Combination With Bevacizumab for Glioblastoma	2015/01/19	NCT02342379	Phase 2	Completed	The University of Texas Health Science Center at San Antonio
A Japanese Trial of TH-302 in Subjects With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma	2014/10/02	NCT02255110	Phase 2	Terminated	Merck KGaA, Darmstadt, Germany
Phase I TH-302 Plus Gemcitabine Plus Nab-Paclitaxel in Pancreatic Cancer	2014/01/28	NCT02047500	Phase 1	Terminated	ImmunoGenesis
A Cardiac Safety Study of TH-302 in Patients With Advanced Solid Tumors	2013/12/24	NCT02020226	Phase 1	UNKNOWN	Threshold Pharmaceuticals
A Phase 2 Biomarker - Enriched Study of TH-302 in Subjects With Advanced Melanoma	2013/05/29	NCT01864538	Phase 2	Terminated	ImmunoGenesis

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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