Clinical Trials

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Phase 1 Program Publications

 Phase 1b study of otlertuzumab (TRU-016), an anti-CD37 monospecific ADAPTIR™ therapeutic protein, in combination with rituximab and bendamustine in relapsed indolent lymphoma patients
Ajay K. Gopal, Stefano R. Tarantolo, Naresh Bellam, Damian J. Green, Melissa Griffin, Tatyana Feldman, Anthony R. Mato, Amy J. Eisenfeld, Scott C. Stromatt, Andre Goy | Investigational New Drugs, The Journal of New Anticancer Agents, 2014

 Recombinant Interleukin-21 Plus Sorafenib For Metastatic Renal Cell Carcinoma A Phase 1/2 Study
Shailender Bhatia1, Brendan Curti, Marc S Ernstoff, Michael Gordon, Elisabeth I Heath, Wilson H Miller Jr, Igor Puzanov, David I Quinn, Thomas W Flaig, Peter VanVeldhuizen, Kelly Byrnes-Blake1, Jeremy A Freeman, Rachel Bittner, Naomi Hunder, Sonia Souza and John A Thompson | Journal for ImmunoTherapy of Cancer 2014, 2:2

 Ceritinib in ALK-Rearranged Non–Small-Cell Lung Cancer
Alice T. Shaw, M.D., Ph.D., Dong-Wan Kim, M.D., Ph.D., Ranee Mehra, M.D., Daniel S.W. Tan, M.B., B.S., Enriqueta Felip, M.D., Ph.D., Laura Q.M. Chow, M.D., D. Ross Camidge, M.D., Ph.D., Johan Vansteenkiste, M.D., Ph.D., Sunil Sharma, M.D., Tommaso De Pas, M.D., Gregory J. Riely, M.D., Ph.D., Benjamin J. Solomon, M.B., B.S., Ph.D., Juergen Wolf, M.D., Ph.D., Michael Thomas, M.D., Martin Schuler, M.D., Geoffrey Liu, M.D., Armando Santoro, M.D., Yvonne Y. Lau, Ph.D., Meredith Goldwasser, Sc.D., Anthony L. Boral, M.D., Ph.D., and Jeffrey A. Engelman, M.D., Ph.D. | N Engl J Med 2014.

Brentuximab vedotin enables successful reduced-intensity allogeneic hematopoietic cell transplantation in patients with relapsed or refractory Hodgkin lymphoma
Robert Chen, Joycelynne M. Palmer, Sandra H. Thomas, Ni-Chun Tsai, Len Farol, Auayporn Nademanee, Stephen J. Forman and Ajay K. Gopal | Prepublished online May 18, 2012; doi:10.1182/blood-2012-03-418673

Safety and Activity of Anti–PD-L1 Antibody in Patients with Advanced Cancer
Julie R. Brahmer, M.D., Scott S. Tykodi, M.D., Ph.D., Laura Q.M. Chow, M.D., Wen-Jen Hwu, M.D., Ph.D., Suzanne L. Topalian, M.D., Patrick Hwu, M.D., Charles G. Drake, M.D., Ph.D., Luis H. Camacho, M.D., M.P.H., John Kauh, M.D., Kunle Odunsi, M.D., Ph.D., Henry C. Pitot, M.D., Omid Hamid, M.D., Shailender Bhatia, M.D., Renato Martins, M.D., M.P.H., Keith Eaton, M.D., Ph.D., Shuming Chen, Ph.D., Theresa M. Salay, M.S., Suresh Alaparthy, Ph.D., Joseph F. Grosso, Ph.D., Alan J. Korman, Ph.D., Susan M. Parker, Ph.D., Shruti Agrawal, Ph.D., Stacie M. Goldberg, M.D., Drew M. Pardoll, M.D., Ph.D., Ashok Gupta, M.D., Ph.D., and Jon M. Wigginton, M.D. | N Engl J Med 2012.

Clinical Binding Properties, Internalization Kinetics, and Clinicopathologic Activity of Brentuximab Vedotin: An Antibody-Drug Conjugate for CD30-Positive Lymphoid Neoplasms
Jonathan R. Fromm, Julie A. McEarchern, Dana Kennedy, Anju Thomas, Andrei R. Shustov, Ajay K. Gopal | Clinical Lymphoma, Myeloma & Leukemia, Vol. 12, No. 4, 280-3

Phase 1 trial of ALT-801, and interleukin-2/T cell receptor fusion protein targeting p53 (aa264-272)/HLA-A*0201 complex, in patients with advanced malignancies.
Fishman, M.N., Thompson, J.A., Pennock, G.K., Gonzalez, R., Diez, L., Daud, A., Weber, J.S., Huang, B.Y., Tang, S., Rhode, P.R., and Wong, H.C. | Clin Cancer Res, 17:7765-7775, 2011