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3. Corrigendum to “Comprehensive clinical and molecular characterization of claudin 18.2 expression in advanced gastric or gastroesophageal junction cancer”

Author

Kubota, Y., primary, Kawazoe, A., additional, Mishima, S., additional, Nakamura, Y., additional, Kotani, D., additional, Kuboki, Y., additional, Bando, H., additional, Kojima, T., additional, Doi, T., additional, Yoshino, T., additional, Kuwata, T., additional, and Shitara, K., additional

Published
2024
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4. 155P A phase I study exploring the safety and tolerability of the small-molecule PD-L1 inhibitor INCB099280 in select advanced solid tumors

Author

Prenen, H., primary, Lesimple, T., additional, Robert, M., additional, Machiels, J-P., additional, Delafontaine, B.R., additional, Tomasini, P., additional, Meniawy, T., additional, Kotecki, N., additional, Van Cutsem, E., additional, Piha-Paul, S.A., additional, Schweizer, M.T., additional, Gadgeel, S., additional, Kondo, S., additional, Ouali, K., additional, Kuboki, Y., additional, Daniel, J., additional, Ebiana, V., additional, Howe, J., additional, Spitz, S., additional, and Italiano, A., additional

Published
2023
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5. Erdafitinib in patients with advanced solid tumours with FGFR alterations (RAGNAR): an international, single-arm, phase 2 study

Author

Pant, S, Schuler, M, Iyer, G, Witt, O, Doi, T, Qin, S, Tabernero, J, Reardon, D, Massard, C, Minchom, A, Lugowska, I, Carranza, O, Arnold, D, Gutierrez, M, Winter, H, Stuyckens, K, Crow, L, Najmi, S, Hammond, C, Thomas, S, Santiago-Walker, A, Triantos, S, Sweiti, H, Loriot, Y, Greco, M, Coward, J, Joshua, A, Karapetis, C, Hart, C, Zhang, A, Prenen, H, Goeminne, J, Machiels, J, Rottey, S, Corassa, M, Molin, G, Tiscoski, K, Jardim, D, Mak, M, Fu, W, Yao, H, Huang, J, Jiang, H, Chen, B, Yan, D, Yang, Y, Le Tourneau, C, Penel, N, Salas, S, Blay, J, Brachet, P, Durando, X, Emambux, S, Ravaud, A, Folprecht, G, Ahrens, M, Golf, A, Haag, G, Lordick, F, Desuki, A, Cazzaniga, M, Ciardiello, F, Milella, M, Koyama, T, Hirooka, Y, Okamoto, W, Aogi, K, Kuboki, Y, Lee, J, Kim, S, Ahn, M, Chang, J, Kim, Y, Nam, D, Park, J, Paz-Ares, L, Moreno, V, Cervantes, A, Calvo, M, Falcon, A, Gonzalez, A, Martinez Bueno, A, Garcia-Corbacho, J, Longo, F, Yen, C, Chen, J, Hou, M, Chao, Y, Rau, K, Chiu, T, Feng, Y, Hsu, C, Huang, W, Lai, K, Yeh, S, Palmer, D, Welsh, L, Plummer, R, Bilen, M, Arrowsmith, E, Spigel, D, Zandberg, D, Doroshow, D, Lu-Emerson, C, Moezi, M, Paulson, S, Ward, P, Chaves, J, Grigg, C, Hussein, A, Manda, S, Monticelli, M, Qamar, R, Richey, S, Tamura, D, Wilks, S, Pant S., Schuler M., Iyer G., Witt O., Doi T., Qin S., Tabernero J., Reardon D. A., Massard C., Minchom A., Lugowska I., Carranza O., Arnold D., Gutierrez M., Winter H., Stuyckens K., Crow L., Najmi S., Hammond C., Thomas S., Santiago-Walker A., Triantos S., Sweiti H., Loriot Y., Greco M. A., Coward J., Joshua A., Karapetis C., Hart C., Zhang A., Prenen H., Goeminne J. -C., Machiels J. -P., Rottey S., Corassa M., Molin G. Z. D., Tiscoski K., Jardim D. L. F., Mak M., Fu W., Yao H., Huang J., Jiang H., Chen B., Yan D., Yang Y., Le Tourneau C., Penel N., Salas S., Blay J. -Y., Brachet P. -E., Durando X., Emambux S., Ravaud A., Folprecht G., Ahrens M., Golf A., Haag G. M., Lordick F., Desuki A., Cazzaniga M., Ciardiello F., Milella M., Koyama T., Hirooka Y., Okamoto W., Aogi K., Kuboki Y., Lee J., Kim S. -B., Ahn M. -J., Chang J. H., Kim Y. -M., Nam D. -H., Park J. -S., Paz-Ares L., Moreno V., Cervantes A., Calvo M., Falcon A., Gonzalez A., Martinez Bueno A., Garcia-Corbacho J., Longo F., Yen C. -J., Chen J. -S., Hou M. -F., Chao Y., Rau K. -M., Chiu T. -J., Feng Y. -H., Hsu C. -H., Huang W. -T., Lai K. -M., Yeh S. -P., Palmer D., Welsh L., Plummer R., Bilen M., Arrowsmith E., Spigel D. R., Zandberg D. P., Doroshow D., Lu-Emerson C., Moezi M., Paulson S., Reardon D., Ward P., Chaves J., Grigg C., Hussein A., Manda S., Monticelli M., Qamar R., Richey S. L., Tamura D., Wilks S., Pant, S, Schuler, M, Iyer, G, Witt, O, Doi, T, Qin, S, Tabernero, J, Reardon, D, Massard, C, Minchom, A, Lugowska, I, Carranza, O, Arnold, D, Gutierrez, M, Winter, H, Stuyckens, K, Crow, L, Najmi, S, Hammond, C, Thomas, S, Santiago-Walker, A, Triantos, S, Sweiti, H, Loriot, Y, Greco, M, Coward, J, Joshua, A, Karapetis, C, Hart, C, Zhang, A, Prenen, H, Goeminne, J, Machiels, J, Rottey, S, Corassa, M, Molin, G, Tiscoski, K, Jardim, D, Mak, M, Fu, W, Yao, H, Huang, J, Jiang, H, Chen, B, Yan, D, Yang, Y, Le Tourneau, C, Penel, N, Salas, S, Blay, J, Brachet, P, Durando, X, Emambux, S, Ravaud, A, Folprecht, G, Ahrens, M, Golf, A, Haag, G, Lordick, F, Desuki, A, Cazzaniga, M, Ciardiello, F, Milella, M, Koyama, T, Hirooka, Y, Okamoto, W, Aogi, K, Kuboki, Y, Lee, J, Kim, S, Ahn, M, Chang, J, Kim, Y, Nam, D, Park, J, Paz-Ares, L, Moreno, V, Cervantes, A, Calvo, M, Falcon, A, Gonzalez, A, Martinez Bueno, A, Garcia-Corbacho, J, Longo, F, Yen, C, Chen, J, Hou, M, Chao, Y, Rau, K, Chiu, T, Feng, Y, Hsu, C, Huang, W, Lai, K, Yeh, S, Palmer, D, Welsh, L, Plummer, R, Bilen, M, Arrowsmith, E, Spigel, D, Zandberg, D, Doroshow, D, Lu-Emerson, C, Moezi, M, Paulson, S, Ward, P, Chaves, J, Grigg, C, Hussein, A, Manda, S, Monticelli, M, Qamar, R, Richey, S, Tamura, D, Wilks, S, Pant S., Schuler M., Iyer G., Witt O., Doi T., Qin S., Tabernero J., Reardon D. A., Massard C., Minchom A., Lugowska I., Carranza O., Arnold D., Gutierrez M., Winter H., Stuyckens K., Crow L., Najmi S., Hammond C., Thomas S., Santiago-Walker A., Triantos S., Sweiti H., Loriot Y., Greco M. A., Coward J., Joshua A., Karapetis C., Hart C., Zhang A., Prenen H., Goeminne J. -C., Machiels J. -P., Rottey S., Corassa M., Molin G. Z. D., Tiscoski K., Jardim D. L. F., Mak M., Fu W., Yao H., Huang J., Jiang H., Chen B., Yan D., Yang Y., Le Tourneau C., Penel N., Salas S., Blay J. -Y., Brachet P. -E., Durando X., Emambux S., Ravaud A., Folprecht G., Ahrens M., Golf A., Haag G. M., Lordick F., Desuki A., Cazzaniga M., Ciardiello F., Milella M., Koyama T., Hirooka Y., Okamoto W., Aogi K., Kuboki Y., Lee J., Kim S. -B., Ahn M. -J., Chang J. H., Kim Y. -M., Nam D. -H., Park J. -S., Paz-Ares L., Moreno V., Cervantes A., Calvo M., Falcon A., Gonzalez A., Martinez Bueno A., Garcia-Corbacho J., Longo F., Yen C. -J., Chen J. -S., Hou M. -F., Chao Y., Rau K. -M., Chiu T. -J., Feng Y. -H., Hsu C. -H., Huang W. -T., Lai K. -M., Yeh S. -P., Palmer D., Welsh L., Plummer R., Bilen M., Arrowsmith E., Spigel D. R., Zandberg D. P., Doroshow D., Lu-Emerson C., Moezi M., Paulson S., Reardon D., Ward P., Chaves J., Grigg C., Hussein A., Manda S., Monticelli M., Qamar R., Richey S. L., Tamura D., and Wilks S.

Abstract

Background: FGFR alterations are reported across various malignancies and might act as oncogenic drivers in multiple histologies. Erdafitinib is an oral, selective pan-FGFR tyrosine kinase inhibitor with activity in FGFR-altered advanced urothelial carcinoma. We aimed to evaluate the safety and activity of erdafitinib in previously treated patients with FGFR-altered advanced solid tumours. Methods: The single-arm, phase 2 RAGNAR study was conducted at 156 investigative centres (hospitals or oncology practices that are qualified oncology study centres) across 15 countries. The study consisted of four cohorts based on tumour histology and patient age; the results reported in this Article are for the primary cohort of the study, defined as the Broad Panel Cohort, which was histology-agnostic. We recruited patients aged 12 years or older with advanced or metastatic tumours of any histology (except urothelial cancer) with predefined FGFR1–4 alterations (mutations or fusions according to local or central testing). Eligible patients had disease progression on at least one previous line of systemic therapy and no alternative standard therapy available to them, and an Eastern Cooperative Oncology Group performance status of 0–1 (or equivalent for adolescents aged 12–17 years). Patients received once-daily oral erdafitinib (8 mg/day with provision for pharmacodynamically guided up-titration to 9 mg/day) on a continuous 21-day cycle until disease progression or intolerable toxicity. The primary endpoint was objective response rate by independent review committee according to Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1, or Response Assessment In Neuro-Oncology (RANO). The primary analysis was conducted on the treated population of the Broad Panel Cohort. This ongoing study is registered with ClinicalTrials.gov, number NCT04083976. Findings: Patients were recruited between Dec 5, 2019, and Feb 15, 2022. Of 217 patients treated with erdafitinib, 97 (45%) pa

Published
2023

8. 45MO Sotorasib in combination with panitumumab in refractory KRAS G12C-mutated colorectal cancer: Safety and efficacy for phase Ib full expansion cohort

Author

Kuboki, Y., primary, Yaeger, R., additional, Fakih, M., additional, Strickler, J.H., additional, Masuishi, T., additional, Kim, E.J-H., additional, Bestvina, C.M., additional, Langer, C.J., additional, Krauss, J.C., additional, Puri, S., additional, Cardona, P., additional, Chang, E.K., additional, Tran, Q., additional, and Hong, D.S., additional

Published
2022
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10. 444TiP Trial in progress: A phase Ib study of sotorasib, a selective KRAS G12C inhibitor, in combination with panitumumab and FOLFIRI in treatment naïve and previously treated metastatic colorectal cancer (CodeBreaK 101)

Author

Masuishi, T., primary, Kuboki, Y., additional, Fakih, M.G., additional, Strickler, J.H., additional, Furqan, M., additional, Kim, E.J., additional, Cardona, P., additional, Tran, Q., additional, Chan, E., additional, and Hong, D.S., additional

Published
2022
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12. 315O Sotorasib in combination with panitumumab in refractory KRAS G12C-mutated colorectal cancer: Safety and efficacy for phase Ib full expansion cohort

Author

Kuboki, Y., primary, Yaeger, R., additional, Fakih, M.G., additional, Strickler, J.H., additional, Masuishi, T., additional, Kim, E.J., additional, Bestvina, C.M., additional, Langer, C.J., additional, Krauss, J.C., additional, Puri, S., additional, Cardona, P., additional, Chan, E., additional, Tran, Q., additional, and Hong, D.S., additional

Published
2022
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14. 505O Sotorasib (soto), panitumumab (pani) and FOLFIRI in the first-line (1L) setting for KRAS G12C–mutated metastatic colorectal cancer (mCRC): Safety and efficacy analysis from the phase Ib CodeBreaK 101 study

Author

Siena, S., Yamaguchi, K., Ruffinelli Rodriguez, J.C., Corral de la Fuente, E., Kuboki, Y., Cremolini, C., Victoria Ruiz, I., Elez Fernandez, M.E., Strickler, J.H., Furqan, M., Bashir, B., Nduka, C., Hippenmeyer, J., Chan, E., Xia, C., and Masuishi, T.

Published
2024
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15. 1439P ABBV-400, a c-Met protein–targeting antibody-drug conjugate (ADC), in patients (pts) with advanced gastric/gastroesophageal junction adenocarcinoma (GEA): Results from a phase I study

Author

Strickler, J.H., Raimbourg, J., Ghiringhelli, F., Cohen, J.E., Kitagawa, C., Sharma, M.R., Lee, K.H., De Miguel, M., Hunter, Z.N., Burns, M., Li, R.R., Rudraganguly, N., Biesdorf de Almeida, C., Freise, K.J., Blaney, M.E., Morrison-Thiele, G., Neagu Aristide, M.R., and Kuboki, Y.

Published
2024
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20. 608O Preliminary safety and clinical activity of ASP3082, a first-in-class, KRAS G12D selective protein degrader in adults with advanced pancreatic (PC), colorectal (CRC), and non-small cell lung cancer (NSCLC)

Author

Park, W., Kasi, A., Spira, A.I., Berlin, J.D., Wang, J.S., Herzberg, B., Kuboki, Y., Kitano, S., Pelster, M., Goldman, J.W., Morgensztern, D., Kondo, S., Jänne, P.A., Fujii, H., Lee, H-J., Gill, S., Saci, A., Lorusso, P., and Tolcher, A.W.

Published
2024
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22. SO-19 Biomarker analysis using plasma angiogenesis factors in the TRUSTY study: A randomized phase 2/3 study of trifluridine/tipiracil plus bevacizumab as second-line treatment for metastatic colorectal cancer

Author

Taniguchi, H., primary, Kuboki, Y., additional, Watanabe, J., additional, Terazawa, T., additional, Kawakami, H., additional, Yokota, M., additional, Nakamura, M., additional, Kotaka, M., additional, Sugimoto, N., additional, Ojima, H., additional, Oki, E., additional, Kajiwara, T., additional, Moriwaki, T., additional, Takayama, T., additional, Denda, T., additional, Tamura, T., additional, Sunakawa, Y., additional, Ishihara, S., additional, Nakajima, T., additional, Morita, S., additional, Shirao, K., additional, and Yoshino, T., additional

Published
2022
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23. 142P Updated results from a phase I, open-label, multicenter, first-in-human study of AMG 404, a checkpoint inhibitor, in patients with advanced solid tumors

Author

Price, T.J., primary, Prenen, H., additional, Lugowska, I., additional, Falchook, G.S., additional, Monzon, J.G., additional, Arkenau, H.T., additional, Chawla, S.P., additional, Hui, M.N., additional, Kuboki, Y., additional, Dziadziuszko, R., additional, Ozawa, Y., additional, Elez Fernandez, M.E., additional, Rocha Lima, C.S.P., additional, Subbiah, V., additional, Tan, D.S.W., additional, Wang, K., additional, Hindoyan, A., additional, Shi, W., additional, Kistler, M., additional, and Hashemi Sadraei, N., additional

Published
2021
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28. 545P First-in-human (FIH) study of E7130 in patients (pts) with advanced solid tumors: Primary result of dose-escalation part

Author

Doi, T., primary, Matsubara, N., additional, Naito, Y., additional, Kuboki, Y., additional, Harano, K., additional, Ono, M., additional, Urasaki, T., additional, Ohmoto, A., additional, Hisai, T., additional, Mikubo, A., additional, Ikezawa, H., additional, Shiba, S., additional, Ito, K., additional, Asano, O., additional, and Takahashi, S., additional

Published
2021
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31. Safety, Pharmacokinetics, and Preliminary Efficacy of Talazoparib in Japanese Patients With Advanced Solid Tumors: Phase 1 Study

Author

Kuboki Y, Ikeda M, Nobuaki Matsubara, Kenichi Harano, Yoichi Naito, Nagasawa T, T. Kogawa, Hori N, Toyoizumi S, and Mori Y

Subjects
Oncology, chemistry.chemical_compound, medicine.medical_specialty, Text mining, Pharmacokinetics, chemistry, business.industry, Internal medicine, Phase (matter), medicine, Talazoparib, business
Abstract

Background: Talazoparib is a poly(ADP-ribose) polymerase enzyme inhibitor. This open-label, non-randomized, phase 1 study of talazoparib investigated the safety, pharmacokinetics, and preliminary antitumor activity in Japanese patients with locally advanced or metastatic solid tumors, regardless of mutations in DNA damage repair-related genes, who are resistant to/ineligible for standard therapies.Methods: Patients received talazoparib dosed orally at 0.75 or 1 mg once daily using a modified 3+3 dose-escalation scheme. Primary endpoint was dose-limiting toxicities during the first cycle of talazoparib.Results: Nine patients (median age 62.0 years) were included: 3 and 6 patients at the 0.75 and 1.0 mg once-daily dose level, respectively. No dose-limiting toxicities were reported. The most commonly reported treatment-emergent adverse events (≥2 patients) were anemia, stomatitis, maculopapular rash, platelet count decreased, neutrophil count decreased, and alanine aminotransferase increased. Three patients had grade ≥3 treatment-emergent adverse events (anemia, brain metastases [1 patient each], and neutrophil and white blood cell count decreased [same patient]). Two patients temporarily discontinued treatment due to a treatment-emergent adverse event, and 1 patient required a dose reduction for neutrophil count decreased (all at 1 mg once daily). Talazoparib exposure (Cmax and AUC) after single and multiple dosing was slightly higher proportionally with talazoparib 1 mg than talazoparib 0.75 mg. The overall disease control rate was 44.4%, including 2 patients with stable disease. The recommended phase 2 dose of talazoparib was established as 1 mg once daily.Conclusions: Single-agent talazoparib was well tolerated and had preliminary antitumor activity in Japanese patients with advanced solid tumors. Clinical Trial Register: clinicalTrials.govClinical Registration Number: NCT03343054 (November 17, 2017)

Published
2021

40. KRASG12C Inhibition with Sotorasib in Advanced Solid Tumors

Author

Hong, DS, Fakih, MG, Strickler, JH, Desai, J, Durm, GA, Shapiro, GI, Falchook, GS, Price, TJ, Sacher, A, Denlinger, CS, Bang, Y-J, Dy, GK, Krauss, JC, Kuboki, Y, Kuo, JC, Coveler, AL, Park, K, Kim, TW, Barlesi, F, Munster, PN, Ramalingam, SS, Burns, TF, Meric-Bernstam, F, Henary, H, Ngang, J, Ngarmchamnanrith, G, Kim, J, Houk, BE, Canon, J, Lipford, JR, Friberg, G, Lito, P, Govindan, R, Li, BT, Hong, DS, Fakih, MG, Strickler, JH, Desai, J, Durm, GA, Shapiro, GI, Falchook, GS, Price, TJ, Sacher, A, Denlinger, CS, Bang, Y-J, Dy, GK, Krauss, JC, Kuboki, Y, Kuo, JC, Coveler, AL, Park, K, Kim, TW, Barlesi, F, Munster, PN, Ramalingam, SS, Burns, TF, Meric-Bernstam, F, Henary, H, Ngang, J, Ngarmchamnanrith, G, Kim, J, Houk, BE, Canon, J, Lipford, JR, Friberg, G, Lito, P, Govindan, R, and Li, BT

Abstract

BACKGROUND: No therapies for targeting KRAS mutations in cancer have been approved. The KRAS p.G12C mutation occurs in 13% of non-small-cell lung cancers (NSCLCs) and in 1 to 3% of colorectal cancers and other cancers. Sotorasib is a small molecule that selectively and irreversibly targets KRASG12C. METHODS: We conducted a phase 1 trial of sotorasib in patients with advanced solid tumors harboring the KRAS p.G12C mutation. Patients received sotorasib orally once daily. The primary end point was safety. Key secondary end points were pharmacokinetics and objective response, as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. RESULTS: A total of 129 patients (59 with NSCLC, 42 with colorectal cancer, and 28 with other tumors) were included in dose escalation and expansion cohorts. Patients had received a median of 3 (range, 0 to 11) previous lines of anticancer therapies for metastatic disease. No dose-limiting toxic effects or treatment-related deaths were observed. A total of 73 patients (56.6%) had treatment-related adverse events; 15 patients (11.6%) had grade 3 or 4 events. In the subgroup with NSCLC, 32.2% (19 patients) had a confirmed objective response (complete or partial response) and 88.1% (52 patients) had disease control (objective response or stable disease); the median progression-free survival was 6.3 months (range, 0.0+ to 14.9 [with + indicating that the value includes patient data that were censored at data cutoff]). In the subgroup with colorectal cancer, 7.1% (3 patients) had a confirmed response, and 73.8% (31 patients) had disease control; the median progression-free survival was 4.0 months (range, 0.0+ to 11.1+). Responses were also observed in patients with pancreatic, endometrial, and appendiceal cancers and melanoma. CONCLUSIONS: Sotorasib showed encouraging anticancer activity in patients with heavily pretreated advanced solid tumors harboring the KRAS p.G12C mutation. Grade 3 or 4 treatment-related t

Published
2020

44. High-density linkage map of rice with expressed sequence tags

Author

Antonio, B. A., primary, Shomura, A., additional, Shimano, T., additional, Kuboki, Y., additional, Lin, S. Y., additional, Inoue, T., additional, Kajiya, H., additional, Harushima, Y., additional, Yamamoto, K., additional, Nagamura, Y., additional, Kurata, N., additional, Yano, M., additional, Minobe, Y., additional, and Sasaki, T., additional

Published
2008
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46. 83MO AMG 510, a novel small molecule inhibitor of KRAS(G12C), for patients (pts) with advanced gastrointestinal (GI) cancers: Results from the CodeBreaK100 phase I trial

Author

Strickler, J.H., primary, Fakih, M., additional, Price, T.J., additional, Desai, J., additional, Durm, G., additional, Krauss, J.C., additional, Kuboki, Y., additional, Kim, T.W., additional, Sacher, A., additional, Henary, H., additional, Kim, J., additional, and Hong, D.S., additional

Published
2020
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