Completed Clinical Trials
Resminostat
- Resminostat monotherapy and S-1/resminostat combination therapy in biliary tract or pancreatic cancer
- Resminostat in combination with sorafenib in Asian patients with advanced hepatocellular carcinoma (HCC)
- SHELTER – Combination of sorafenib and resminostat in hepatocellular carcinoma (HCC)
- SAPHIRE – Resminostat in Hodgkin´s lymphoma (HL)
- Combination of resminostat and docetaxel versus docetaxel in non-small cell lung cancer (NSCLC) in Japan and Korea
- SHORE – Combination of resminostat and FOLFIRI in colorectal cancer (CRC)
- Resminostat in Japanese patients with advanced solid tumors
- First-in-human study of resminostat in advanced solid tumors
- Resminostat plus S-1 in biliary tract cancer (BTC)
Domatinostat (4SC-202)
- TOPAS – First-in-human study of domatinostat (4SC-202) in hematologic malignancies
- SENSITIZE – Domatinostat in Combination With Pembrolizumab in Patients Primary Refractory/Non-responding to Prior Anti-PD-1 Therapy
- EMERGE – Epigenetic Modulation of the immunE Response in GastrointEstinal Cancers (investigator-sponsored trial)
- DONIMI – Multicenter Phase 1b Trial Testing the Neoadjuvant Combination of Domatinostat, Nivolumab and Ipilimumab in IFN-gamma Signature-low and IFN-gamma Signature-high RECIST 1.1-measurable Stage III Cutaneous or Unknown Primary Melanoma (investigator-sponsored trial)
- TURANDOT – Checkpoint Inhibition With or Without Domatinostat in Urothelial Cancer (investigator sponsored trial)
Resminostat monotherapy and S-1/resminostat combination therapy in biliary tract or pancreatic cancer
This is an open-label, dose escalation Phase I study to evaluate the dose-limiting toxicities (DLTs) of resminostat monotherapy and S-1/resminostat combination therapy in Japanese patients with unresectable/recurrent biliary tract or pancreatic cancer to determine the recommended dose regimen/s to be used in subsequent Phase II trials conducted by our cooperation partner Yakult Honsha.
| Recruitment status | Completed |
| Study phase | Phase I |
| Enrollment | Up to 44 |
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| Key secondary objective |
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| Publication | Phase I study of resminostat, an HDAC inhibitor, combined with S-1 in patients with pre-treated biliary tract or pancreatic cancer
Masafumi Ikeda, Izumi Ohno, Hideki Ueno, Shuichi Mitsunaga, Yusuke Hashimoto, Takuji Okusaka, Shunsuke Kondo, Mitsuhito Sasaki, Yasunari Sakamoto, Hideaki Takahashi, Rina Hara, Shingo Kobayashi, Osamu Nakamura, Chigusa Morizane. Invest New Drugs. 2019 Feb;37(1):109-117. doi: 10.1007/s10637-018-0634-5. Epub 2018 Jul 11. |
Resminostat in combination with sorafenib in Asian patients with advanced hepatocellular carcinoma (HCC)
This study was a multi-national, multi-center, randomized, double-blind, placebo-controlled Phase II study to evaluate resminostat in combination with sorafenib for the first-line treatment of advanced HCC, conducted by our cooperation partner Yakult Honsha.
| Recruitment status | Completed |
| Study Phase | Phase II |
| Enrollment | 170 |
| Primary objective |
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| Secondary objectives |
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| Exploratory objectives |
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| Poster | Resminostat and sorafenib combination therapy for advanced hepatocellular carcinoma in patients previously untreated with systemic chemotherapy
Kudo M, Ryoo BY, Lim HY, Kim DY, Okusaka T, Ikeda M, Hidaka H, Yeon JE, Mizukoshi E, Morimoto M, Lee MA, Yasui K, Kawaguchi Y, Heo J, Morita S, Kim TY, Furuse J, Katayama K, Aramaki T, Tak WY. |
| Publication | Phase I/II study of first-line combination therapy with sorafenib plus resminostat, an oral HDAC inhibitor, versus sorafenib monotherapy for advanced hepatocellular carcinoma in east Asian patients
Won Young Tak, Baek-Yeol Ryoo, Ho Yeong Lim, Do-Young Kim, Takuji Okusaka, Masafumi Ikeda, Hisashi Hidaka, Jong-Eun Yeon, Eishiro Mizukoshi, Manabu Morimoto, Myung-Ah Lee, Kohichiroh Yasui, Yasunori Kawaguchi, Jeong Heo, Sojiro Morita, Tae-You Kim, Junji Furuse, Kazuhiro Katayama, Takeshi Aramaki, Rina Hara, Takuya Kimura, Osamu Nakamura, Masatoshi Kudo Investigational New Drugs, 10 September 2018, DOI: 10.1007/s10637-018-0658-x |
SHELTER – Combination of sorafenib and resminostat in hepatocellular carcinoma (HCC)
The SHELTER study was a multi-national, multi-center, single arm Phase II study to evaluate efficacy, safety and pharmacokinetics of resminostat and the treatment combination of sorafenib and resminostat in patients with HCC exhibiting progressive disease (PD) under sorafenib treatment.
| Recruitment status | Completed |
| Study phase | Phase II |
| Enrollment | 57 |
| Primary objective |
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| Secondary objectives |
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| Publication | Resminostat plus sorafenib as second-line therapy of advanced hepatocellular carcinoma – The SHELTER study.
Bitzer M, Horger M, Giannini EG, Ganten TM, Wörns MA, Siveke JT, Dollinger MM, Gerken G, Scheulen ME, Wege H, Zagonel V, Cillo U, Trevisani F, Santoro A, Montesarchio V, Malek NP, Holzapfel J, Herz T, Ammendola AS, Pegoraro S, Hauns B, Mais A, Lauer UM, Henning SW, Hentsch B. J Hepatol. 2016 Aug;65(2):280-8. doi: 10.1016/j.jhep.2016.02.043. |
SAPHIRE – Resminostat in Hodgkin’s Lymphoma
The SAPHIRE study was a multi-national, multi-center, single arm Phase II study to evaluate the efficacy, safety and pharmacokinetics of resminostat in patients with relapsed or refractory HL.
| Recruitment status | Completed |
| Study Phase | Phase II |
| Enrollment | 37 |
| Primary objective |
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| Secondary objectives |
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| Exploratory objectives |
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| Publication | Resminostat in patients with relapsed or refractory Hodgkin lymphoma: results of the phase II SAPHIRE study
Jan Walewski, Ewa Paszkiewicz-Kozik, Gabriela Borsaru, Andrzej Hellmann, Andrea Janikova, Agnieszka Warszewska, Anna Mais, Astrid Ammendola, Thomas Herz, Babett Krauss & Stefan W. Henning Leukemia & Lymphoma, 30 August 2018, DOI: 10.1080/10428194.2018.1492122 |
Combination of resminostat and docetaxel versus docetaxel in non-small cell lung cancer (NSCLC) in Japan and Korea
This study was a Phase I/II study to evaluate safety, tolerability and anti-tumor activity of resminostat in combination with docetaxel in pretreated Asian patients with NSCLC, conducted by our cooperation partner Yakult Honsha.
| Recruitment status | Completed |
| Study phase | Phase I/II |
| Enrollment | 9/108 |
| Primary objective (Phase I) |
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| Primary objective (Phase II) |
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| Secondary objectives (Phase II) |
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| Exploratory objectives (Phase II) |
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| Publication | Phase I/II study of docetaxel combined with resminostat, an oral hydroxamic acid HDAC inhibitor, for advanced non-small cell lung cancer in patients previously treated with platinum-based chemotherapy.
Tambo Y, Hosomi Y, Sakai H, Nogami N, Atagi S, Sasaki Y, Kato T, Takahashi T, Seto T, Maemondo M, Nokihara H, Koyama R, Nakagawa K, Kawaguchi T, Okamura Y, Nakamura O, Nishio M, Tamura T. Invest New Drugs. 2017 Jan 30. doi: 10.1007/s10637-017-0435-2. [Epub ahead of print] |
SHORE – Combination of Resminostat and FOLFIRI in Colorectal Cancer (CRC)
The SHORE study was a national, multi-center Phase I/II study to evaluate safety, tolerability, pharmacokinetics and efficacy of resminostat in combination with a second-line treatment in patients with K-ras mutated advanced CRC. The Phase II part of the study was not conducted.
| Recruitment status | Completed |
| Study phase | Phase I/II |
| Enrollment | 17 |
| Primary objective |
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| Secondary objectives |
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Resminostat in Japanese patients with advanced solid tumors
This study was a mono-center, single arm Phase I study of resminostat in Japanese patients with solid tumors, conducted by our cooperation partner Yakult Honsha.
| Recruitment status | Completed |
| Study phase | Phase I |
| Enrollment | 12 |
| Primary objective |
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| Secondary objectives |
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| Publication | A phase I study of resminostat in Japanese patients with advanced solid tumors.
Kitazono S, Fujiwara Y, Nakamichi S, Mizugaki H, Nokihara H, Yamamoto N, Yamada Y, Inukai E, Nakamura O, Tamura T. Cancer Chemother Pharmacol. 2015 Jun;75(6):1155-61. doi: 10.1007/s00280-015-2741-8. |
First-in-human study of resminostat in advanced solid tumors
This study was a first-in-human, mono-center, single arm, open label, dose escalation study of resminostat in patients with advanced solid tumors.
| Recruitment status | Completed |
| Study phase | Phase I |
| Enrollment | 19 |
| Primary objectives |
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| Secondary objectives |
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| Publication | First-in-human, pharmacokinetic and pharmacodynamic phase I study of Resminostat, an oral histone deacetylase inhibitor, in patients with advanced solid tumors.
Brunetto AT, Ang JE, Lal R, Olmos D, Molife LR, Kristeleit R, Parker A, Casamayor I, Olaleye M, Mais A, Hauns B, Strobel V, Hentsch B, de Bono JS. Clin Cancer Res. 2013 Oct 1;19(19):5494-504. doi: 10.1158/1078-0432.CCR-13-0735. |
Resminostat plus S-1 in biliary tract cancer (BTC)
This was a double-blind, randomized Phase II study to assess the efficacy of resminostat in combination with S-1 (experimental arm) compared to placebo in combination with S-1 (control arm) in patients with unresectable or platinum-gemcitabine combination refractory biliary tract cancer conducted by our cooperation partner Yakult Honsha.
| Recruitment status | Completed |
| Study phase | Phase II |
| Enrollment | 101 |
| Primary objective |
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| Secondary objective |
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| Exploratory objective |
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| Publication | Phase I study of resminostat, an HDAC inhibitor, combined with S-1 in patients with pre-treated biliary tract or pancreatic cancer. Invest New Drugs 2019 Feb;37(1):109-117.Doi: 10.1007/s10637-018-0634-5 |
TOPAS – First-in-human study of domatinostat (4SC-202) in hematologic malignancies
The TOPAS study was a first-in-human, multi-center, single arm, open label, dose escalation study of domatinostat in patients with advanced hematologic malignancies.
| Recruitment status | Completed |
| Study phase | Phase I |
| Enrollment | 24 |
| Primary objectives |
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| Secondary objectives |
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| Exploratory objectives |
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| Publication | Phase I Study of Domatinostat (4SC‐202), a class I Histone Deacetylase Inhibitor in Patients with Advanced Hematological Malignancies
Bastian von Tresckow, Cyrus Sayehli, Walter E. Aulitzky, Maria‐Elisabeth Goebeler, Matthias Schwab, Eunice Braz, Babett Krauss, Rolf Krauss, Frank Hermann, René Bartz, Andreas Engert European Journal of Haematology, 2018 Oct 22; doi: 10.1111/ejh.13188 |
SENSITIZE – Domatinostat in Combination With Pembrolizumab in Patients Primary Refractory/Non-responding to Prior Anti-PD-1 Therapy
The SENSITIZE study is an open-label, multi-center, Phase Ib/II study to evaluate the combination treatment of domatinostat with the anti-PD-1 antibody pembrolizumab (Keytruda®) in patients suffering from advanced-stage cutaneous melanoma who are refractory or non-responding to prior treatment with anti-PD-1 antibodies.
| Recruitment status | Completed |
| Study phase | Phase Ib/II |
| Enrollment | 40 |
| Primary objective |
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| Key secondary objectives |
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| Exploratory objective |
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EMERGE – Epigenetic Modulation of the immunE Response in GastrointEstinal Cancers (investigator-sponsored trial)
The EMERGE study is an open-label, multi-center, Phase II study to evaluate the combination treatment of domatinostat with the anti-PD-L1 antibody avelumab (Bavencio®) in patients suffering from microsatellite-stable esophago-gastric and colorectal (MSS-GI) cancer. The investigator-sponsored study is conducted by Prof. David Cunningham from The Royal Marsden NHS Foundation Trust (London, UK).
| Recruitment status | Completed |
| Study phase | Phase II |
| Enrollment | 29 |
| Primary objective |
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| Key secondary objectives |
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DONIMI – Multicenter Phase 1b Trial Testing the Neoadjuvant Combination of Domatinostat, Nivolumab and Ipilimumab in IFN-gamma Signature-low and IFN-gamma Signature-high RECIST 1.1-measurable Stage III Cutaneous or Unknown Primary Melanoma (investigator-sponsored trial)
The multicenter phase 1b study DONIMI is testing the combination of domatinostat, nivolumab, and ipilimumab, in high risk stage III melanoma in the neoadjuvant setting. The investigator-sponsored study is conducted by Prof. Christian Blank, MD, Medical Oncologyst, and Group Leader at the Division of Immunology, The Netherlands Cancer Institute, Amsterdam.
| Recruitment status | Completed |
| Study phase | Phase Ib |
| Enrollment | 44 |
| Primary objective |
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| Key secondary objectives |
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TURANDOT – Checkpoint Inhibition With or Without Domatinostat in Urothelial Cancer (investigator sponsored trial)
The multicenter phase 1b study TURANDOT is testing the combination of domatinostat, nivolumab, and ipilimumab, in high risk stage II-III urothelial cancer in the neoadjuvant setting. The investigator-sponsored study is conducted by Prof. Michiel S. van der Heijden, MD, Medical oncologist and Group Leader at The Netherlands Cancer Institute, Amsterdam.
| Recruitment status | Terminated |
| Study phase | Phase Ib |
| Enrollment | 9 |
| Primary objective |
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| Key secondary objectives |
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