研究実績

Lucassen MJJ, Bergmann P, Husson O, Banerji U, Basu B, Melero I, Calvo E, Cassier PA, Drilon A, Fong PC, Garralda E, Joshua AM, Lin CC, Lopez J, Moreno V, Minchom A, Plummer R, Postel-Vinay S, Spreafico A, Shimizu T, Yap TA, Yap C, De Bono JS, Steeghs N. Barriers to publishing early phase clinical trials: the oncologists’ perspective. Oncologist 2025 Apr 4;30(4):oyaf042.doi: 10.1093/oncolo/oyaf042.

Hayato S, Hamuro L, Shimizu T, Yonemori K, Nishio S, Yunokawa M, Yoshida T, Nishio M, Matsumoto K, Takehara K, Hasegawa K, Kozuki T, Hirashima Y, Kato H, Miura T, Nomoto M, Zhao Y, Zhu L, Yasuda S. Pharmacokinetic and Exposure-Response Modeling Support Body Surface Area-Based Dosing of Farletuzumab Ecteribulin in Japanese Patients with Solid Tumors. J Clin Pharmacol. 2025 Jan 24. doi: 10.1002/jcph.6187. Online ahead of print.

Hata, T., Yamada, T., Goto, Y., Amano, A., Negi, Y., Watanabe, S., Furuya, N., Oba, T., Ikoma, T., Nakao, A., Tanimura, K., Taniguchi, H., Yoshimura, A., Fukui, T., Murata, D., Kaira, K., Shiotsu, S., Hibino, M., Okada, A., Chihara, Y., … Takayama, K. (2025). Comparative analysis of first-line treatment in NSCLC including unresectable stage III (IIIB/IIIC) and stage IV with low PD-L1 expression: Clinical trial eligible versus ineligible patients. Lung cancer (Amsterdam, Netherlands), 200, 108104. https://doi.org/10.1016/j.lungcan.2025.108104

Hata, T., Yamada, T., Goto, Y., Amano, A., Negi, Y., Watanabe, S., Furuya, N., Oba, T., Ikoma, T., Nakao, A., Tanimura, K., Taniguchi, H., Yoshimura, A., Fukui, T., Murata, D., Kaira, K., Shiotsu, S., Hibino, M., Okada, A., Chihara, Y., … Takayama, K. (2025). Regimen Selection for Chemoimmunotherapy in Nonsquamous Non-Small Cell Lung Cancer with Low PD-L1 Expression: A Multicenter Retrospective Cohort Study. Clinical lung cancer, S1525-7304(25)00001-4. Advance online publication. https://doi.org/10.1016/j.cllc.2025.01.002

Katsushima, U., Kurose, S., Fukushima, T., Nakano, J., Ogushi, N., Fujii, K., Nagata, Y., Kamisako, K., Okuno, Y., Okazaki, Y., Nakanishi, K., Yoshida, K., Ikoma, T., Takeyasu, Y., Yamanaka, Y., Yoshioka, H., Hase, K., & Kurata, T. (2025). Impact of time to treatment initiation on the development of cachexia and clinical outcomes in lung cancer. Japanese journal of clinical oncology, 55(5), 505–513. https://doi.org/10.1093/jjco/hyaf009

Katsushima, U., Fukushima, T., Nakano, J., Ogushi, N., Fujii, K., Nagata, Y., Kamisako, K., Okuno, Y., Okazaki, Y., Nakanishi, K., Yoshida, K., Ikoma, T., Takeyasu, Y., Yamanaka, Y., Yoshioka, H., Hase, K., & Kurata, T. (2025). Comparative Study on Associations Between Lung Cancer Prognosis and Diagnostic Criteria Set by the European Palliative Care Research Collaboration and the Asian Working Group for Cachexia. Thoracic cancer, 16(2), e15503. https://doi.org/10.1111/1759-7714.15503

Nishioka, N., Hata, T., Yamada, T., Goto, Y., Amano, A., Negi, Y., Watanabe, S., Furuya, N., Oba, T., Ikoma, T., Nakao, A., Tanimura, K., Taniguchi, H., Yoshimura, A., Fukui, T., Murata, D., Kaira, K., Shiotsu, S., Hibino, M., Okada, A., … Takayama, K. (2025). Impact of TTF-1 Expression on the Prognostic Prediction of Patients with Non-Small Cell Lung Cancer with PD-L1 Expression Levels of 1% to 49%, Treated with Chemotherapy vs. Chemoimmunotherapy: A Multicenter, Retrospective Study. Cancer research and treatment, 57(2), 412–421. https://doi.org/10.4143/crt.2024.748

Yamanaka, Y., Okuno, Y., Kamisako, K., Okazaki, Y., Nakanishi, K., Sanada, Y., Yoshida, K., Ikoma, T., Takeyasu, Y., Katsushima, U., Yoshioka, H., & Kurata, T. (2024). Efficacy and Safety Evaluation of Immune Checkpoint Inhibitors in Combination With Chemotherapy for Extensive Small Cell Lung Cancer: Real-World Evidence. Cancer medicine, 13(24), e70480. https://doi.org/10.1002/cam4.70480

Ikoma, T., Matsumoto, T., Boku, S., Motoki, Y., Kinoshita, H., Kosaka, H., Kaibori, M., Inoue, K., Sekimoto, M., Fujisawa, T., Iwai, H., Naganuma, M., Tanizaki, H., Hisamatsu, Y., Okada, H., & Kurata, T. (2024). Safety of immune checkpoint inhibitors in patients aged over 80 years: a retrospective cohort study. Cancer immunology, immunotherapy : CII, 73(7), 126. https://doi.org/10.1007/s00262-024-03707-4

Katsushima, U., Hase, K., Fukushima, T., Kubo, T., Nakano, J., Ogushi, N., Okuno, Y., Kamisako, K., Nakanishi, K., Okazaki, Y., Ikoma, T., Takeyasu, Y., Yamanaka, Y., Yoshioka, H., Imai, Y., & Kurata, T. (2024). Investigation of a practical assessment index to capture the clinical presentation of cachexia in patients with lung cancer. Japanese journal of clinical oncology, 54(3), 305–311. https://doi.org/10.1093/jjco/hyad177

Shimizu T, Powderly J, Razak A, LoRusso P, Miller KD, Kao S, Kongpachith S, Graham M, Stoll B, Patel M, Sahtout M, Blaney M, Leibman RS, Golan T, Tolcher AW. First-in-human Phase I Dose Escalation Results with Livmoniplimab, an Atibody Targeting the GARP:TGF-β1 Complex, as Monotherapy and in Combination with the Anti–PD-1 Antibody Budigalimab in Patients with Advanced Solid Tumors Frontiers in Oncology 2024 Oct 29;14:1376551. doi: 10.3389/fonc.2024.1376551

Giuseppe Curigliano, Miguel Martin Jimenez , Shimizu T, Bhumsuk Keam, Funda Meric-Bernstam, Annemie Rutten, John Glaspy, Patrick J. Schuler, Nehal S. Parikh, Mary Ising, Nadia Hassounah, Jincheng Wu, Malgorzata Leyk, Xinhui Chen, Heather Burks , Anwesha Chaudhury, Javier Otero, Elena Garralda Cabanas. A phase 1 trial of LHC165 single agent and in combination with spartalizumab in patients with advanced solid malignancies ESMO Open 2024 Aug;9(8):103643.doi: 10.1016/j.esmoop.2024.103643

Peterlin P, Saada-Bouzid E, Moskovitz M, Pigneux A, Yuda J, Sinnollareddy M, Henner WR, Chen D, Freise KJ, Leibman RS, Avigdor A, Shimizu T First-in-Human Clinical Trial Results with ABBV-184, a First-in-Class T-cell Receptor/Anti-CD3 Bispecific Antibody, in Adults With Previously Treated AML or NSCLC. Expert Review of Anticancer Therapy Jul 1. doi: 10.1080/14737140.2024

Kuboki Y, Koyama T, Matsubara N, Naito Y, Kondo S, Harano K, Yonemori K, Yoh K, Gu Y, Mita T, Chen X, Ueda E, Yamamoto N, Doi T, Shimizu T PD-1 inhibition with retifanlimab and/or arginase inhibition with INCB001158 in Japanese patients with solid tumors: A phase I study Cancer Medicine 2024 Apr;13(8):e6980. doi: 10.1002/cam4.6980.

Bardia A, Krop IE, Kogawa T, Juric D, Tolcher AW, Hamilton EP, Mukohara T, Lisberg A, Shimizu T, Spira AI, Tsurutani J, Damodaran S, Papadopoulos KP, Greenberg J, Kobayashi F, Zebger-Gong H, Wong R, Kawasaki Y, Tadakatsu N, Meric-Bernstam F. Datopotamab Deruxtecan in Advanced or Metastatic HR+/HER2– and Triple-Negative Breast Cancer: Results From the Phase I TROPION-PanTumor01 Study J Clin Oncol 2024 Jul 1;42(19):2281-2294. doi: 10.1200/JCO.23.01909

Akito Hata , Nobuyuki Katakami , Naoto Takase , Kayoko Kibata , Yuta Yamanaka , Motohiro Tamiya , Masahide Mori , Takashi Kijima , Satoshi Morita , Kazuko Sakai , Kazuto Nishio. Afatinib plus bevacizumab combination after osimertinib resistance in advanced EGFR-mutant non-small cell lung cancer: Phase II ABCD-study. Lung Cancer. 2024;197, 107988.

Shigehiro Yagishita , Yuta Yamanaka ,Takayasu Kurata ,Kageaki Watanabe ,Yukio Hosomi ,Hidehito Horinouchi ,Yuichiro Ohe ,Yoshiro Nakahara ,Katsuhiko Naoki ,Tetsuhiko Asao ,Kazuhisa Takahashi ,Sho Saeki ,Takuro Sakagami ,Kazuhisa Nakashima ,Yukari Tsubata ,Yu Fujita ,Hiroshi Wakui ,Megumi Furuta ,Jun Sakakibara Konishi ,Mayu Ohuchi ,Yuichi Ando ,Hidenori Mizugaki ,Akinobu Hamada. Multicenter Pharmacokinetic and Pharmacodynamic Study of Pembrolizumab for Non-small-Cell Lung Cancer in Patients Aged 75 Years and Older. Clinical Pharmacology and Therapeutics . 2024;116(4), 1042-1051.

Akihiro Yoshimura ,Takayuki Takeda ,Nobutaka Kataoka ,Keiko Tanimura ,Mototaka Fukui ,Yusuke Chihara , Shota Takei ,Hayato Kawachi ,Kentaro Nakanishi ,Yuta Yamanaka ,Nobuyo Tamiya ,Ryoichi Honda ,Naoko Okura , Takahiro Yamada ,Kiyoaki Uryu ,Junji Murai ,Shinsuke Shiotsu ,Hiroshige Yoshioka ,Tadaaki Yamada ,Takayasu Kurata ,KoichiTakayama. Impact of the response to platinum-based chemotherapy on the second-line immune checkpoint inhibitor monotherapy in non-small cell lung cancer with PD-L1 expression ≤49%: a multicenter retrospective study. Frontiers in Oncology. 2024;14, 1303543.

Shimizu T, Sands J, Yoh K, Spira A, Garon EB, Kitazono S, Johnson ML, Meric-Bernstam F, Tolcher AW, Yamamoto N, Jon Greenberg, Yui Kawasaki, Hong Zebger-Gong, Kobayashi F, Phillips P, Lisberg AE, Heist RS. First-in-Human, Phase 1 Dose-Escalation and -Expansion Study of TROP2- Directed Antibody Drug Conjugate Datopotamab Deruxtecan in Non-Small Cell Lung Cancer: TROPION-PanTumor 01 J Clin Oncol 2023 Oct 10; 41(29): 4678–4687

Shimizu T, Nakagawa K, Hayashi H, Iwasa T, Kawakami H, Watanabe S, Yamamoto N, Yonemori K, Koyama T, Sato J, Tamura K, Kikuchi K, Akaike K, Takeda S, Takeda M. Oral formulation of bendamustine hydrochloride (SyB C-0501) for patients with advanced solid tumors: A phase 1 study Invest New Drugs 2023; 41(1): 1–12

Matsubara N, Kunihara S, Yamamoto N, Sudo K, Yanagita M, Murayama K, Kawasumi H, Russell D, Yin D, Shimizu T Safety, tolerability, pharmacokinetics, and anti-tumor activity of imaradenant (AZD4635) in Japanese patients with advanced solid malignancies: A phase 1, open-label study Cancer Chemother Pharmacol 2023 Dec 13.doi: 10.1007/s00280-023-04605-9.

10. Keiko Tanimura, Takayuki Takeda, Nobutaka Kataoka, Akihiro Yoshimura, Kentaro Nakanishi, Yuta Yamanaka, Hiroshige Yoshioka, Ryoichi Honda, Kiyoaki Uryu, Mototaka Fukui, Yusuke Chihara, Shota Takei, Hayato Kawachi, Tadaaki Yamada, Nobuyo Tamiya, Naoko Okura, Takahiro Yamada, Junji Murai, Shinsuke Shiotsu, Takayasu Kurata, Koichi Takayama. First-Line Chemoimmunotherapy versus Sequential Platinum-Based Chemotherapy Followed by Immunotherapy in Patients with Non-Small Cell Lung Cancer with ≤49% Programmed Death-Ligand 1 Expression: A Real-World Multicenter Retrospective Study. Cancers. 2023;15(20), 4988.

11. Takayuki Takeda, Tadaaki Yamada, Yusuke Kunimatsu, Keiko Tanimura, Kenji Morimoto, Shinsuke Shiotsu, Yusuke Chihara, Asuka Okada, Shigeto Horiuchi, Makoto Hibino, Kiyoaki Uryu, Ryoichi Honda, Yuta Yamanaka, Hiroshige Yoshioka, Takayasu Kurata, Koichi Takayama. Age-Stratified Analysis of First-Line Chemoimmunotherapy for Extensive-Stage Small Cell Lung Cancer: Real-World Evidence from a Multicenter Retrospective Study. Cancers. 2023;15(5), 1543.

Shimizu T, Nakajima TE, Yamamoto N, Yonemori K, Koyama T, Kondo S, Sunakawa Y, Izawa N, Horie Y, Xiang S, Xu S, Qin L, Gong J, Liu D. Phase I study of envafolimab (KN035), the first subcutaneously administered, novel fusion anti-PD-L1 antibody in Japanese patients with advanced solid tumors Invest New Drugs 2022. 40(5):1021-1031

Kitano S, Fujiwara Y, Shimizu T, Iwasa S, Yonemori K, Kondo S, Shimomura A, Koyama T, Ebata T, Ikezawa H, Hayata N, Minoshima Y, Miura T, Kubota T, Yamamoto N. A dose-finding and feasibility study of lenvatinib plus pembrolizumab in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol 2022

Takamizawa S, Katsuya Y, Chen YN, Mizuno T, Koyama T, Sudo K, Yoshida T, Kondo S, Iwasa S, Yonemori K, Shimizu T, Yamamoto N, Suzuki S. Ocular Toxicity of Investigational Anti-Cancer Drugs in Early Phase Clinical Trials Invest New Drugs 2022

Mizuno T, Katsuya Y, Sato J, Koyama T, Shimizu T, Yamamoto N. Emerging PD-1/PD-L1 targeting immunotherapy in non-small cell lung cancer: Current status and future perspective in Japan, US, EU, and China Frontier Oncology 2022

Bernstam Sweis RF, Virchow SK, Hamid O, Bhatia S, Dummer R, Stradella A, Long G, Spreafico A, Shimizu T, Steeghs N, Luke JJ, McWhirter SM, Müller T, Nair N, Lewis N, Chen H, Bean A, Kattenhorn L, Pelletier M, Sandhu S. Combination of the STING Agonist MIW815 (ADU-S100) and PD-1 Inhibitor Spartalizumab in Advanced/Metastatic Solid Tumors or Lymphomas: An Open-label, Multicenter, Phase Ib Study Clin Cancer Res 2022

Weiss A, Lorthiois E, Barys L, Beyer KS, Bomio-Confaglia C, Burks H, Chen X, Cui X, De Kanter R, Dharmarajan L, Fedele C, Gerspacher M, Guthy DA, Head V, Jaeger A, Nunez EJ, Kearns J, LeBlanc C, Maira SM, Murphy J, Oakman H, Ostermann N, Ottl J, Rigollier P, Roman D, Schnell C, Sedrani R, Shimizu T, Stringer R, Vaupel A, Voshol H, Wessels P, Widmer T, Wilcken R, Xu K, Zecri F, Farago A, Brachmann SM, Cotesta S. Discovery and preclinical characterization of JDQ443, a structurally unique, highly potent, selective and orally bioavailable covalent inhibitor of KRASG12C Cancer Discovery 2022

Kuboki Y, Shimizu T, Yonemori K, Kojima T, Kondo S, Koganemaru S, Iwasa S, Harano K, Koyama T, Lu V, Zhou X, Niu H, Yanai T, Garcia-Ribas I, Doi T, Yamamoto N. A phase 1 first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of TAK-931, a cell division cycle 7 inhibitor, in patients with advanced solid tumors Cancer Research Communications 2022

Koyama T, Shimizu T, Sato J, Katsuya Y, Iwasa S, Kondo S, Yoshida T, Sudo K, Nishino M, Takiguchi Y, Yonemori K, Yamamoto N. Practical consideration for success in sequential tumor biopsies in oncology first-in-human trials. Invest New Drugs 2022 Apr 11.doi: 10.1007/s10637-022-01236-4.

Sato J, Shimizu T, Koyama T, Iwasa S, Shimomura A, Kondo S, Kitano S, Yonemori K, Fujiwara Y, Tamura K, Suzuki T, Takase T, Nagai R, Yamaguchi K, Semba T, Zhao Z, Li S, Yamamoto N. Phase 1 Study of the Liposomal Formulation of Eribulin (E7389-LF) in Japanese Patients with Advanced Solid Tumors: Results from the Dose Escalation Part Clin Cancer Res 2022

Hagiwara Y, Nakasya A, Matsumoto T, Ikoma T, Yamamoto Y, Kurioka Y, Tsuduki T, Kajiwara T, Nishina T, Yamashita N, Moriwaki T, Hyodo I. Risk factors and efficacy outcomes of early-onset severe neutropenia due to paclitaxel or nanoparticle albumin-bound paclitaxel combined with ramucirumab in advanced gastric cancer: a multicenter retrospective cohort study. J Gastrointest Oncol. 2022 Dec;13(6):2769-2778.

Boku, S., Satake, H., Ohta, T., Mitani, S., Kawakami, K., Suzuki, Y., Matsumoto, T., Terazawa, T., Yamazaki, E., Hasegawa, H., Ikoma, T., Uemura, M., Yamaguchi, T., Naito, A., Ishizuka, Y., Kurokawa, Y., Sakai, D., Kawakami, H., Shimokawa, T., Tsujinaka, T., … Kagawa, Y. (2022). TRESBIEN (OGSG 2101): encorafenib, binimetinib and cetuximab for early recurrent stage II/III BRAF V600E-mutated colorectal cancer. Future oncology (London, England), 18(38), 4153–4160.

Matsumoto, T., Yamamura, S., Ikoma, T., Kurioka, Y., Doi, K., Yasuda, T., Boku, S., Kawai, T., Shibata, N., Nagai, H., Tsuduki, T., Shimada, T., Matsumoto, Y., Tsumura, T., Takatani, M., Yasui, H., & Satake, H. (2022). Real-World Data of Trifluridine/Tipiracil for Patients With Advanced Gastric Cancer: A Multi-Institutional Retrospective Study. Clinical Medicine Insights. Oncology, 16, 11795549221137135. https://doi.org/10.1177/11795549221137135

Ikoma, T., Matsumoto, T., Kurioka, Y., Takatani, M., Nagai, H., Matsumoto, Y., Satake, H., & Yasui, H. (2022). Improvement of Body Weight and Nutritional Status in Gastric Cancer Patients Enhances the Benefit of Nivolumab Therapy. Journal of clinical medicine, 11(20), 6100. https://doi.org/10.3390/jcm11206100

Ikoma, T., Shimokawa, M., Matsumoto, T., Boku, S., Yasuda, T., Shibata, N., Kurioka, Y., Takatani, M., Nobuhisa, T., Namikawa, T., Kitagawa, H., Hanazaki, K., Doi, K., Shimada, T., Tsumura, T., Marusawa, H., Kanaya, S., Morita, S., Inokuma, T., Nagai, H., … Satake, H. (2023). Inflammatory prognostic factors in advanced or recurrent esophageal squamous cell carcinoma treated with nivolumab. Cancer immunology, immunotherapy : CII, 72(2), 427–435. https://doi.org/10.1007/s00262-022-03265-7

Matsumoto, T., Yamamura, S., Ikoma, T., Kurioka, Y., Doi, K., Boku, S., Shibata, N., Nagai, H., Shimada, T., Tsuduki, T., Tsumura, T., Takatani, M., Yasui, H., & Satake, H. (2022). Real-World Data of Trastuzumab Deruxtecan for Advanced Gastric Cancer: A Multi-Institutional Retrospective Study. Journal of clinical medicine, 11(8), 2247. https://doi.org/10.3390/jcm11082247

Ikoma, T., Shimokawa, M., Kotaka, M., Matsumoto, T., Nagai, H., Boku, S., Shibata, N., Yasui, H., & Satake, H. (2021). Clinical and prognostic features of patients with detailed RAS/BRAF-mutant colorectal cancer in Japan. BMC cancer, 21(1), 518. https://doi.org/10.1186/s12885-021-08271-z

Nakasya, A., Hagiwara, Y., Ikoma, T., Kurioka, Y., Matsumoto, T., Yamamoto, Y., Tsuduki, T., Kajiwara, T., Moriwaki, T., Nishina, T., Yamashita, N., & Hyodo, I. (2022). Nanoparticle albumin-bound paclitaxel and ramucirumab versus paclitaxel and ramucirumab as second-line chemotherapy for unresectable advanced or recurrent gastric cancer: a multicenter, propensity score-matched analysis (CROSS SELL study). International journal of clinical oncology, 27(4), 684–694. https://doi.org/10.1007/s10147-022-02114-y