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Howard A. Burris
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Journal Articles

First-in-Human Phase I/II ICONIC Trial of the ICOS Agonist Vopratelimab Alone and with Nivolumab: ICOS-High CD4 T-Cell Populations and Predictors of Response

Timothy A. Yap, Justin F. Gainor, Margaret K. Callahan, Gerald S. Falchook, Russell K. Pachynski, Patricia LoRusso, Shivaani Kummar, Geoffrey T. Gibney, Howard A. Burris, Scott S. Tykodi, Osama E. Rahma, Tanguy Y. Seiwert, Kyriakos P. Papadopoulos, Mariela Blum Murphy, Haeseong Park, Amanda Hanson, Yasmin Hashambhoy-Ramsay, Lara McGrath, Ellen Hooper, Xiaoying Xiao, Heather Cohen, Martin Fan, Daniel Felitsky, Courtney Hart, Rachel McComb, Karen Brown, Ali Sepahi, Judith Jimenez, Weidong Zhang, Johan Baeck, Haley Laken, Richard Murray, Elizabeth Trehu, Christopher J. Harvey
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (17): 3695–3708.
https://doi.org/10.1158/1078-0432.CCR-21-4256
Published: 01 September 2022
View article titled, First-in-Human Phase I/II ICONIC Trial of the ICOS Agonist Vopratelimab Alone and with Nivolumab: ICOS-High CD4 T-Cell Populations and Predictors of Response
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Includes: Supplementary data
Journal Articles

First-In-Human Phase I Study of the OX40 Agonist MOXR0916 in Patients with Advanced Solid Tumors

Tae Won Kim, Howard A. Burris, III, Maria J. de Miguel Luken, Michael J. Pishvaian, Yung-Jue Bang, Michael Gordon, Ahmad Awada, D. Ross Camidge, F. Stephen Hodi, Grant A. McArthur, Wilson H. Miller, Jr, Andres Cervantes, Laura Q. Chow, Alexander M. Lesokhin, Annemie Rutten, Mario Sznol, Deepali Rishipathak, Shang-Chiung Chen, Eric Stefanich, Tony Pourmohamad, Maria Anderson, Jeong Kim, Mahrukh Huseni, Ina Rhee, Lillian L. Siu
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (16): 3452–3463.
https://doi.org/10.1158/1078-0432.CCR-21-4020
Published: 15 August 2022
View article titled, First-In-Human Phase I Study of the OX40 Agonist MOXR0916 in Patients with Advanced Solid Tumors
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Includes: Supplementary data
Journal Articles

Vorasidenib, a Dual Inhibitor of Mutant IDH1/2, in Recurrent or Progressive Glioma; Results of a First-in-Human Phase I Trial

Ingo K. Mellinghoff, Marta Penas-Prado, Katherine B. Peters, Howard A. Burris, III, Elizabeth A. Maher, Filip Janku, Gregory M. Cote, Macarena I. de la Fuente, Jennifer L. Clarke, Benjamin M. Ellingson, Saewon Chun, Robert J. Young, Hua Liu, Sung Choe, Min Lu, Kha Le, Islam Hassan, Lori Steelman, Shuchi S. Pandya, Timothy F. Cloughesy, Patrick Y. Wen
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (16): 4491–4499.
https://doi.org/10.1158/1078-0432.CCR-21-0611
Published: 15 August 2021
View article titled, Vorasidenib, a Dual Inhibitor of Mutant IDH1/2, in Recurrent or Progressive Glioma; Results of a First-in-Human Phase I Trial
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Includes: Supplementary data
Journal Articles

Phase I Study of TAK-659, an Investigational, Dual SYK/FLT3 Inhibitor, in Patients with B-Cell Lymphoma

Leo I. Gordon, Jason B. Kaplan, Rakesh Popat, Howard A. Burris, III, Silvia Ferrari, Sumit Madan, Manish R. Patel, Giuseppe Gritti, Dima El-Sharkawi, Ian Chau, John A. Radford, Jaime Pérez de Oteyza, Pier Luigi Zinzani, Swaminathan Iyer, William Townsend, Reem Karmali, Harry Miao, Igor Proscurshim, Shining Wang, Yujun Wu, Kate Stumpo, Yaping Shou, Cecilia Carpio, Francesc Bosch
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2020) 26 (14): 3546–3556.
https://doi.org/10.1158/1078-0432.CCR-19-3239
Published: 15 July 2020
View article titled, Phase I Study of TAK-659, an Investigational, Dual SYK/FLT3 Inhibitor, in Patients with B-Cell Lymphoma
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Includes: Supplementary data
Journal Articles

Phase Ia Study of Anti-NaPi2b Antibody–Drug Conjugate Lifastuzumab Vedotin DNIB0600A in Patients with Non–Small Cell Lung Cancer and Platinum-Resistant Ovarian Cancer

David E. Gerber, Jeffrey R. Infante, Michael S. Gordon, Sarah B. Goldberg, Miguel Martín, Enriqueta Felip, Maria Martinez Garcia, Joan H. Schiller, David R. Spigel, Julie Cordova, Valerie Westcott, Yulei Wang, David S. Shames, YounJeong Choi, Robert Kahn, Randall C. Dere, Divya Samineni, Jian Xu, Kedan Lin, Katie Wood, Stephanie Royer-Joo, Vanessa Lemahieu, Eva Schuth, Anjali Vaze, Daniel Maslyar, Eric W. Humke, Howard A. Burris, III
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (2): 364–372.
https://doi.org/10.1158/1078-0432.CCR-18-3965
Published: 15 January 2020
View article titled, Phase Ia Study of Anti-NaPi2b Antibody–Drug Conjugate Lifastuzumab Vedotin DNIB0600A in Patients with Non–Small Cell Lung Cancer and Platinum-Resistant Ovarian Cancer
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Includes: Supplementary data
Journal Articles

Challenges with Novel Clinical Trial Designs: Master Protocols

Michael Cecchini, Eric H. Rubin, Gideon M. Blumenthal, Kassa Ayalew, Howard A. Burris, Michele Russell-Einhorn, Hildy Dillon, H. Kim Lyerly, Gregory H. Reaman, Scott Boerner, Patricia M. LoRusso
Journal: Clinical Cancer Research
Clin Cancer Res (2019) 25 (7): 2049–2057.
https://doi.org/10.1158/1078-0432.CCR-18-3544
Published: 01 April 2019
View article titled, Challenges with Novel Clinical Trial Designs: Master Protocols
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Journal Articles

Evaluation of Prexasertib, a Checkpoint Kinase 1 Inhibitor, in a Phase Ib Study of Patients with Squamous Cell Carcinoma

David S. Hong, Kathleen Moore, Manish Patel, Stefan C. Grant, Howard A. Burris, III, William N. William, Jr, Suzanne Jones, Funda Meric-Bernstam, Jeffrey Infante, Lisa Golden, Wei Zhang, Ricardo Martinez, Sameera Wijayawardana, Richard Beckmann, Aimee Bence Lin, Cathy Eng, Johanna Bendell
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2018) 24 (14): 3263–3272.
https://doi.org/10.1158/1078-0432.CCR-17-3347
Published: 15 July 2018
View article titled, Evaluation of Prexasertib, a Checkpoint Kinase 1 Inhibitor, in a Phase Ib Study of Patients with Squamous Cell Carcinoma
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Includes: Supplementary data
Journal Articles

A First-Time-in-Human Study of GSK2636771, a Phosphoinositide 3 Kinase Beta-Selective Inhibitor, in Patients with Advanced Solid Tumors

Joaquin Mateo, Gopinath Ganji, Charlotte Lemech, Howard A. Burris, Sae-Won Han, Karen Swales, Shaun Decordova, M. Phillip DeYoung, Deborah A. Smith, Shanker Kalyana-Sundaram, Jiuhua Wu, Monica Motwani, Rakesh Kumar, Jerry M. Tolson, Sun Young Rha, Hyun Cheol Chung, Joseph P. Eder, Sunil Sharma, Yung-Jue Bang, Jeffrey R. Infante, Li Yan, Johann S. de Bono, Hendrik-Tobias Arkenau
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2017) 23 (19): 5981–5992.
https://doi.org/10.1158/1078-0432.CCR-17-0725
Published: 01 October 2017
View article titled, A First-Time-in-Human Study of GSK2636771, a Phosphoinositide 3 Kinase Beta-Selective Inhibitor, in Patients with Advanced Solid Tumors
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Includes: Supplementary data
Journal Articles

A Phase I/Ib Study of Enzalutamide Alone and in Combination with Endocrine Therapies in Women with Advanced Breast Cancer

Lee S. Schwartzberg, Denise A. Yardley, Anthony D. Elias, Manish Patel, Patricia LoRusso, Howard A. Burris, Ayca Gucalp, Amy C. Peterson, Martha E. Blaney, Joyce L. Steinberg, Jacqueline A. Gibbons, Tiffany A. Traina
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (15): 4046–4054.
https://doi.org/10.1158/1078-0432.CCR-16-2339
Published: 01 August 2017
View article titled, A Phase I/Ib Study of Enzalutamide Alone and in Combination with Endocrine Therapies in Women with Advanced Breast Cancer
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Includes: Supplementary data
Journal Articles

A Phase I–II Study of the Oral PARP Inhibitor Rucaparib in Patients with Germline BRCA1/2-Mutated Ovarian Carcinoma or Other Solid Tumors

Rebecca Kristeleit, Geoffrey I. Shapiro, Howard A. Burris, Amit M. Oza, Patricia LoRusso, Manish R. Patel, Susan M. Domchek, Judith Balmaña, Yvette Drew, Lee-may Chen, Tamar Safra, Ana Montes, Heidi Giordano, Lara Maloney, Sandra Goble, Jeff Isaacson, Jim Xiao, Jen Borrow, Lindsey Rolfe, Ronnie Shapira-Frommer
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2017) 23 (15): 4095–4106.
https://doi.org/10.1158/1078-0432.CCR-16-2796
Published: 01 August 2017
View article titled, A Phase I–II Study of the Oral PARP Inhibitor Rucaparib in Patients with Germline <em>BRCA1/2</em>-Mutated Ovarian Carcinoma or Other Solid Tumors
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Includes: Supplementary data
Journal Articles

A Phase I Dose-Escalation Study Evaluating the Safety Tolerability and Pharmacokinetics of CUDC-427, a Potent, Oral, Monovalent IAP Antagonist, in Patients with Refractory Solid Tumors

Anthony W. Tolcher, Johanna C. Bendell, Kyriakos P. Papadopoulos, Howard A. Burris, Amita Patnaik, Wayne J. Fairbrother, Harvey Wong, Nageshwar Budha, Walter C. Darbonne, Franklin Peale, Michael Mamounas, Stephanie Royer-Joo, Ron Yu, Chia C. Portera, Jeffrey R. Infante
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (18): 4567–4573.
https://doi.org/10.1158/1078-0432.CCR-16-0308
Published: 15 September 2016
View article titled, A Phase I Dose-Escalation Study Evaluating the Safety Tolerability and Pharmacokinetics of CUDC-427, a Potent, Oral, Monovalent IAP Antagonist, in Patients with Refractory Solid Tumors
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Journal Articles

Phase I Study of PSMA-Targeted Docetaxel-Containing Nanoparticle BIND-014 in Patients with Advanced Solid Tumors

Daniel D. Von Hoff, Monica M. Mita, Ramesh K. Ramanathan, Glen J. Weiss, Alain C. Mita, Patricia M. LoRusso, Howard A. Burris, III, Lowell L. Hart, Susan C. Low, Donald M. Parsons, Stephen E. Zale, Jason M. Summa, Hagop Youssoufian, Jasgit C. Sachdev
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2016) 22 (13): 3157–3163.
https://doi.org/10.1158/1078-0432.CCR-15-2548
Published: 30 June 2016
View article titled, Phase I Study of PSMA-Targeted Docetaxel-Containing Nanoparticle BIND-014 in Patients with Advanced Solid Tumors
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Includes: Supplementary data
Journal Articles

Phase I Study of Apitolisib (GDC-0980), Dual Phosphatidylinositol-3-Kinase and Mammalian Target of Rapamycin Kinase Inhibitor, in Patients with Advanced Solid Tumors

Saoirse O. Dolly, Andrew J. Wagner, Johanna C. Bendell, Hedy L. Kindler, Lee M. Krug, Tanguy Y. Seiwert, Marjorie G. Zauderer, Martijn P. Lolkema, Doris Apt, Ru-Fang Yeh, Jill O. Fredrickson, Jill M. Spoerke, Hartmut Koeppen, Joseph A. Ware, Jennifer O. Lauchle, Howard A. Burris, 3rd, Johann S. de Bono
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (12): 2874–2884.
https://doi.org/10.1158/1078-0432.CCR-15-2225
Published: 14 June 2016
View article titled, Phase I Study of Apitolisib (GDC-0980), Dual Phosphatidylinositol-3-Kinase and Mammalian Target of Rapamycin Kinase Inhibitor, in Patients with Advanced Solid Tumors
Open the PDF for Phase I Study of Apitolisib (GDC-0980), Dual Phosphatidylinositol-3-Kinase and Mammalian Target of Rapamycin Kinase Inhibitor, in Patients with Advanced Solid Tumors in another window
Includes: Supplementary data
Journal Articles

Dual Targeting of HER2-Positive Cancer with Trastuzumab Emtansine and Pertuzumab: Critical Role for Neuregulin Blockade in Antitumor Response to Combination Therapy

Gail D. Lewis Phillips, Carter T. Fields, Guangmin Li, Donald Dowbenko, Gabriele Schaefer, Kathy Miller, Fabrice Andre, Howard A. Burris, III, Kathy S. Albain, Nadia Harbeck, Veronique Dieras, Diana Crivellari, Liang Fang, Ellie Guardino, Steven R. Olsen, Lisa M. Crocker, Mark X. Sliwkowski
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2014) 20 (2): 456–468.
https://doi.org/10.1158/1078-0432.CCR-13-0358
Published: 16 January 2014
View article titled, Dual Targeting of HER2-Positive Cancer with Trastuzumab Emtansine and Pertuzumab: Critical Role for Neuregulin Blockade in Antitumor Response to Combination Therapy
Open the PDF for Dual Targeting of HER2-Positive Cancer with Trastuzumab Emtansine and Pertuzumab: Critical Role for Neuregulin Blockade in Antitumor Response to Combination Therapy in another window
Includes: Supplementary data
Journal Articles

Phase I Study of Aurora A Kinase Inhibitor MLN8237 in Advanced Solid Tumors: Safety, Pharmacokinetics, Pharmacodynamics, and Bioavailability of Two Oral Formulations

E. Claire Dees, Roger B. Cohen, Margaret von Mehren, Thomas E. Stinchcombe, Hua Liu, Karthik Venkatakrishnan, Mark Manfredi, Howard Fingert, Howard A. Burris, III, Jeffrey R. Infante
Journal: Clinical Cancer Research
Clin Cancer Res (2012) 18 (17): 4775–4784.
https://doi.org/10.1158/1078-0432.CCR-12-0589
Published: 30 August 2012
View article titled, Phase I Study of Aurora A Kinase Inhibitor MLN8237 in Advanced Solid Tumors: Safety, Pharmacokinetics, Pharmacodynamics, and Bioavailability of Two Oral Formulations
Open the PDF for Phase I Study of Aurora A Kinase Inhibitor MLN8237 in Advanced Solid Tumors: Safety, Pharmacokinetics, Pharmacodynamics, and Bioavailability of Two Oral Formulations in another window
Includes: Supplementary data
Journal Articles

Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of TH-302, a Hypoxia-Activated Prodrug, in Patients with Advanced Solid Malignancies

Glen J. Weiss, Jeffrey R. Infante, E. Gabriela Chiorean, Mitesh J. Borad, Johanna C. Bendell, Julian R. Molina, Raoul Tibes, Ramesh K. Ramanathan, Karen Lewandowski, Suzanne F. Jones, Mario E. Lacouture, Virginia K. Langmuir, Hank Lee, Stew Kroll, Howard A. Burris, III
Journal: Clinical Cancer Research
Clin Cancer Res (2011) 17 (9): 2997–3004.
https://doi.org/10.1158/1078-0432.CCR-10-3425
Published: 01 May 2011
View article titled, Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of TH-302, a Hypoxia-Activated Prodrug, in Patients with Advanced Solid Malignancies
Open the PDF for Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of TH-302, a Hypoxia-Activated Prodrug, in Patients with Advanced Solid Malignancies in another window
Includes: Supplementary data
Journal Articles

Lack of Correlation between Epidermal Growth Factor Receptor Status and Response to Panitumumab Monotherapy in Metastatic Colorectal Cancer

J. Randolph Hecht, Edith Mitchell, Marcus A. Neubauer, Howard A. Burris, III, Paul Swanson, Timothy Lopez, Glenn Buchanan, Maureen Reiner, Jennifer Gansert, Jordan Berlin
Journal: Clinical Cancer Research
Clin Cancer Res (2010) 16 (7): 2205–2213.
https://doi.org/10.1158/1078-0432.CCR-09-2017
Published: 31 March 2010
View article titled, Lack of Correlation between Epidermal Growth Factor Receptor Status and Response to Panitumumab Monotherapy in Metastatic Colorectal Cancer
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Journal Articles

Phase 1 Experience with an Anti-Glycotope Monoclonal Antibody, RAV12, in Recurrent Adenocarcinoma

Howard A. Burris, III, Lee S. Rosen, Caio M. Rocha-Lima, John Marshall, Suzanne Jones, Roger B. Cohen, Lori A. Kunkel, Deryk Loo, Jan Baughman, Stanford J. Stewart, Nancy Lewis
Journal: Clinical Cancer Research
Clin Cancer Res (2010) 16 (5): 1673–1681.
https://doi.org/10.1158/1078-0432.CCR-09-2263
Published: 28 February 2010
View article titled, Phase 1 Experience with an Anti-Glycotope Monoclonal Antibody, RAV12, in Recurrent Adenocarcinoma
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Journal Articles

A Phase I Dose-Escalation Study of Danusertib (PHA-739358) Administered as a 24-Hour Infusion with and without Granulocyte Colony-Stimulating Factor in a 14-Day Cycle in Patients with Advanced Solid Tumors

Roger B. Cohen, Suzanne F. Jones, Charu Aggarwal, Margaret von Mehren, Jonathan Cheng, David R. Spigel, F. Anthony Greco, Mariangela Mariani, Maurizio Rocchetti, Roberta Ceruti, Silvia Comis, Bernard Laffranchi, Jurgen Moll, Howard A. Burris
Journal: Clinical Cancer Research
Clin Cancer Res (2009) 15 (21): 6694–6701.
https://doi.org/10.1158/1078-0432.CCR-09-1445
Published: 02 November 2009
View article titled, A Phase I Dose-Escalation Study of Danusertib (PHA-739358) Administered as a 24-Hour Infusion with and without Granulocyte Colony-Stimulating Factor in a 14-Day Cycle in Patients with Advanced Solid Tumors
Open the PDF for A Phase I Dose-Escalation Study of Danusertib (PHA-739358) Administered as a 24-Hour Infusion with and without Granulocyte Colony-Stimulating Factor in a 14-Day Cycle in Patients with Advanced Solid Tumors in another window
Includes: Supplementary data
Journal Articles

A Phase I and Pharmacokinetic Study of Oral Lapatinib Administered Once or Twice Daily in Patients with Solid Malignancies

Howard A. Burris, III, Charles W. Taylor, Suzanne F. Jones, Kevin M. Koch, Melissa J. Versola, Niki Arya, Ronald A. Fleming, Deborah A. Smith, Lini Pandite, Neil Spector, George Wilding
Journal: Clinical Cancer Research
Clin Cancer Res (2009) 15 (21): 6702–6708.
https://doi.org/10.1158/1078-0432.CCR-09-0369
Published: 02 November 2009
View article titled, A Phase I and Pharmacokinetic Study of Oral Lapatinib Administered Once or Twice Daily in Patients with Solid Malignancies
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