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NCT02576496
Study of Tinostamustine, First-in-Class Alkylating HDACi Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies
Phase 1 trial testing Tinostamustine in Hematological Malignancies in 106 participants. Completed in 21 November 2023.
30 May 2023
Quick facts
| Lead sponsor | Mundipharma Research Limited |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 106 |
| Start date | 14 April 2016 |
| Primary completion | 30 May 2023 |
| Estimated completion | 21 November 2023 |
| Sites | 18 locations across France, Italy, Netherlands, Germany, Switzerland, United States, Spain |
Drugs / interventions tested
- Tinostamustine — full drug profile →
Conditions studied
- Hematological Malignancies — all drugs for Hematological Malignancies →
- Multiple Myeloma — all drugs for Multiple Myeloma →
- Hodgkin's Lymphoma — all drugs for Hodgkin's Lymphoma →
- Cutaneous T Cell Lymphoma — all drugs for Cutaneous T Cell Lymphoma →
Sponsor
Mundipharma Research Limited — full company profile →
Who can join
18 and older, any sex, with Hematological Malignancies or Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study evaluates the efficacy, safety and pharmacokinetics of tinostamustine (EDO-S101) in patients with relapsed/refractory hematologic malignancies. All patients will receive tinostamustine.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Histone deacetylase 6 in cancer.
Li T, Zhang C, Hassan S, Liu X, et al · · 2018 · cited 261× · PMID 30176876 · DOI 10.1186/s13045-018-0654-9 -
Epigenetics-targeted drugs: current paradigms and future challenges.
Dai W, Qiao X, Fang Y, Guo R, et al · · 2024 · cited 131× · PMID 39592582 · DOI 10.1038/s41392-024-02039-0 -
Targeting histone deacetylases for cancer therapy: Trends and challenges.
Liang T, Wang F, Elhassan RM, Cheng Y, et al · · 2023 · cited 128× · PMID 37425042 · DOI 10.1016/j.apsb.2023.02.007 -
Recent developments in epigenetic cancer therapeutics: clinical advancement and emerging trends.
Nepali K, Liou JP. · · 2021 · cited 122× · PMID 33840388 · DOI 10.1186/s12929-021-00721-x -
The Therapeutic Strategy of HDAC6 Inhibitors in Lymphoproliferative Disease.
Cosenza M, Pozzi S. · · 2018 · cited 62× · PMID 30096875 · DOI 10.3390/ijms19082337 -
Recent Update of HDAC Inhibitors in Lymphoma.
Chen IC, Sethy B, Liou JP. · · 2020 · cited 60× · PMID 33015069 · DOI 10.3389/fcell.2020.576391 -
Therapeutic challenges in peripheral T-cell lymphoma.
Luan Y, Li X, Luan Y, Luo J, et al · · 2024 · cited 34× · PMID 38178117 · DOI 10.1186/s12943-023-01904-w -
Novel Agents in Multiple Myeloma.
Szalat R, Munshi NC. · · 2019 · cited 21× · PMID 30694859 · DOI 10.1097/ppo.0000000000000355
Verify or expand the search:
- PubMed search for NCT02576496
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tinostamustine
Trials testing the same drug.
- NCT05432375 — Study of Tinostamustine for Adjuvant Treatment of Glioblastoma · EARLY_PHASE1 · completed
- NCT03903458 — Tinostamustine and Nivolumab in Advanced Melanoma · Phase 1 · unknown
- NCT03687125 — Tinostamustine Conditioning and Autologous Stem Cell · Phase 1, PHASE2 · terminated
- NCT03452930 — Tinostamustine With or Without Radiation Therapy in Treating Patients With Newly Diagnosed MGMT-Unmethylated Glioblastom · Phase 1 · completed
Other recruiting trials for Hematological Malignancies
Currently open trials in the same condition.
- NCT07220616 — A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies · Phase 1, PHASE2 · recruiting
- NCT06584955 — Feasibility of the Use of Weighted Blankets to Improve Sleep Among Patients With Hematological Malignancies · NA · active not recruiting
- NCT06387082 — A Clinical Study of HMPL-506 in Patients With Hematological Malignancies · Phase 1 · recruiting
- NCT06150469 — Efficacy of Inhaled Aromatherapy on Nausea and Vomiting in Hematological Malignancies · NA · recruiting
- NCT06179511 — Study of AZD9829 in CD123+ Hematological Malignancies · Phase 1, PHASE2 · active not recruiting
Other Mundipharma Research Limited trials
Trials by the same sponsor.
- NCT06794554 — Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatment Options · Phase 2 · recruiting
- NCT05534529 — Rezafungin Paediatric PK Study in Paediatric Subjects From Birth to <18 Years of Age · Phase 1 · terminated
- NCT05432375 — Study of Tinostamustine for Adjuvant Treatment of Glioblastoma · EARLY_PHASE1 · completed
- NCT04368559 — Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Unde · Phase 3 · completed
- NCT03345485 — Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors. · Phase 1, PHASE2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02576496 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mundipharma Research Limited
- Last refreshed: 25 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02576496.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing