Characterizing Exposure–Response Relationship for Therapeutic Monoclonal Antibodies in Immuno‐Oncology and Beyond: Challenges, Perspectives, and Prospects

por Dai, Haiqing Isaac, Vugmeyster, Yulia, Mangal, Naveen
Publicado 2020

Evaluation of the potential for QTc prolongation with avelumab

por Vugmeyster, Yulia, Güzel, Gülseren, Hennessy, Meliessa, Loos, Anja H., Dai, Haiqing
Publicado 2019

Risk assessment of drug–drug interaction potential for bintrafusp alfa with cytochrome P4503A4 substrates: A totality of evidence approach

por Vugmeyster, Yulia, Locke, George, Helwig, Christoph, Rolfe, P. Alexander, Dong, Jennifer Q., Venkatakrishnan, Karthik
Publicado 2022

Avelumab Dose Selection for Clinical Studies in Pediatric Patients with Solid Tumors

por Vugmeyster, Yulia, Grisic, Ana-Marija, Brockhaus, Brigitte, Rueckert, Peter, Ruisi, Mary, Dai, Haiqing, Khandelwal, Akash
Publicado 2022

Phase I Study of the Bifunctional Fusion Protein Bintrafusp Alfa in Asian Patients with Advanced Solid Tumors, Including a Hepatocellular Carcinoma Safety‐Assessment Cohort

por Doi, Toshihiko, Fujiwara, Yutaka, Koyama, Takafumi, Ikeda, Masafumi, Helwig, Christoph, Watanabe, Morihiro, Vugmeyster, Yulia, Kudo, Masatoshi
Publicado 2020

Model-informed approach for risk management of bleeding toxicities for bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1

por Vugmeyster, Yulia, Grisic, Ana-Marija, Wilkins, Justin J., Loos, Anja H., Hallwachs, Roland, Osada, Motonobu, Venkatakrishnan, Karthik, Khandelwal, Akash
Publicado 2022

Selection of the Recommended Phase 2 Dose for Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF‐β and PD‐L1

por Vugmeyster, Yulia, Wilkins, Justin, Koenig, Andre, El Bawab, Samer, Dussault, Isabelle, Ojalvo, Laureen S., De Banerjee, Samrita, Klopp‐Schulze, Lena, Khandelwal, Akash
Publicado 2020

A multistate modeling and simulation framework to learn dose–response of oncology drugs: Application to bintrafusp alfa in non‐small cell lung cancer

por Liu, Han, Milenković‐Grišić, Ana‐Marija, Krishnan, Sreenath M., Jönsson, Siv, Friberg, Lena E., Girard, Pascal, Venkatakrishnan, Karthik, Vugmeyster, Yulia, Khandelwal, Akash, Karlsson, Mats O.
Publicado 2023

Time‐Varying Clearance and Impact of Disease State on the Pharmacokinetics of Avelumab in Merkel Cell Carcinoma and Urothelial Carcinoma

por Wilkins, Justin J., Brockhaus, Brigitte, Dai, Haiqing, Vugmeyster, Yulia, White, Joleen T., Brar, Satjit, Bello, Carlo L., Neuteboom, Berend, Wade, Janet R., Girard, Pascal, Khandelwal, Akash
Publicado 2019

Correlation of pharmacodynamic activity, pharmacokinetics, and anti-product antibody responses to anti-IL-21R antibody therapeutics following IV administration to cynomolgus monkey...

por Vugmeyster, Yulia, Allen, Scott, Szklut, Pamela, Bree, Andrea, Ryan, Mark, Ma, Margery, Spaulding, Vikki, Young, Deborah, Guay, Heath, Bloom, Laird, Leach, Michael W, O'Toole, Margot, Adkins, Karissa
Publicado 2010

Activation of TrkB with TAM-163 Results in Opposite Effects on Body Weight in Rodents and Non-Human Primates

por Perreault, Mylène, Feng, Guo, Will, Sarah, Gareski, Tiffany, Kubasiak, David, Marquette, Kimberly, Vugmeyster, Yulia, Unger, Thaddeus J., Jones, Juli, Qadri, Ariful, Hahm, Seung, Sun, Ying, Rohde, Cynthia M., Zwijnenberg, Raphael, Paulsen, Janet, Gimeno, Ruth E.
Publicado 2013

Avelumab in paediatric patients with refractory or relapsed solid tumours: dose-escalation results from an open-label, single-arm, phase 1/2 trial

por Loeb, David M., Lee, Ji Won, Morgenstern, Daniel A., Samson, Yvan, Uyttebroeck, Anne, Lyu, Chuhl Joo, Van Damme, An, Nysom, Karsten, Macy, Margaret E., Zorzi, Alexandra P., Xiong, Julia, Pollert, Petra, Joerg, Ingrid, Vugmeyster, Yulia, Ruisi, Mary, Kang, Hyoung Jin
Publicado 2022

Distinct in vitro binding properties of the anti-CD20 small modular immunopharmaceutical 2LM20-4 result in profound and sustained in vivo potency in cynomolgus monkeys

por Nickerson-Nutter, Cheryl, Tchistiakova, Lioudmila, Seth, Nilufer P., Kasaian, Marion, Sibley, Barbara, Olland, Stephane, Zollner, Richard, Brady, William A., Mohler, Kendall M., Baum, Peter, Wahl, Alan, Herber, Deborah, Vugmeyster, Yulia, Wensel, David, Wolfman, Neil M., Gill, Davinder, Collins, Mary, Dunussi-Joannopoulos, Kyri
Publicado 2011

First-in-human phase Ib trial of M9241 (NHS-IL12) plus avelumab in patients with advanced solid tumors, including dose expansion in patients with advanced urothelial carcinoma

por Strauss, Julius, Deville, Jean-Laurent, Sznol, Mario, Ravaud, Alain, Maruzzo, Marco, Pachynski, Russell K, Gourdin, Theodore S, Maio, Michele, Dirix, Luc, Schlom, Jeffrey, Donahue, Renee N, Tsai, Yo-Ting, Wang, XiaoZhe, Vugmeyster, Yulia, Beier, Frank, Seebeck, Joerg, Schroeder, Andreas, Chennoufi, Sarah, Gulley, James L
Publicado 2023

Phase 2 trial of bintrafusp alfa as second-line therapy for patients with locally advanced/metastatic biliary tract cancers

por Yoo, Changhoon, Javle, Milind M., Verdaguer Mata, Helena, de Braud, Filippo, Trojan, Jörg, Raoul, Jean-Luc, Kim, Jin Won, Ueno, Makoto, Lee, Choong-kun, Hijioka, Susumu, Cubillo, Antonio, Furuse, Junji, Azad, Nilofer, Sato, Masashi, Vugmeyster, Yulia, Machl, Andreas, Bajars, Marcis, Bridgewater, John, Oh, Do-Youn, Borad, Mitesh J.
Publicado 2023