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First-In-Human Dose-Escalation Study of Fianlimab, an Anti-Lymphocyte Activation Gene-3 Antibody, with Cemiplimab in patients with advanced malignancies.
Lakhani NJ, Papadopoulos KP, Johnson ML, Park H, Wang D, Yap TA, Dowlati A, Maki RG, Ulahannan S, Lynce F, Kelly K, Williamson S, Malhotra J, Chen S, Gonzalez Ortiz A, Jankovic V, Paccaly A, Masinde S, Mani J, Lowy I, Gullo G, Sims T, Kroog G. Lakhani NJ, et al. Among authors: paccaly a. Clin Cancer Res. 2024 Oct 18. doi: 10.1158/1078-0432.CCR-23-3883. Online ahead of print. Clin Cancer Res. 2024. PMID: 39422598
First-In-Human Study of Cemiplimab Alone or In Combination with Radiotherapy and/or Low-dose Cyclophosphamide in Patients with Advanced Malignancies.
Papadopoulos KP, Johnson ML, Lockhart AC, Moore K, Falchook GS, Formenti SC, Naing A, Carvajal RD, Rosen LS, Weiss GJ, Leidner RS, Li J, Paccaly A, Feng M, Stankevich E, Lowy I, Fury MG, Crittenden MR. Papadopoulos KP, et al. Among authors: paccaly a. Clin Cancer Res. 2020 Mar 1;26(5):1025-1033. doi: 10.1158/1078-0432.CCR-19-2609. Epub 2019 Dec 3. Clin Cancer Res. 2020. PMID: 31796520 Clinical Trial.
Phase I Study of Fianlimab, a Human Lymphocyte Activation Gene-3 (LAG-3) Monoclonal Antibody, in Combination With Cemiplimab in Advanced Melanoma.
Hamid O, Lewis KD, Weise A, McKean M, Papadopoulos KP, Crown J, Kim TM, Lee DH, Thomas SS, Mehnert J, Kaczmar J, Lakhani NJ, Kim KB, Middleton MR, Rabinowits G, Spira AI, Yushak M, Mehmi I, Fang F, Chen S, Mani J, Jankovic V, Wang F, Fiaschi N, Brennan L, Paccaly A, Masinde S, Salvati M, Fury MG, Kroog G, Lowy I, Gullo G. Hamid O, et al. Among authors: paccaly a. J Clin Oncol. 2024 Aug 20;42(24):2928-2938. doi: 10.1200/JCO.23.02172. Epub 2024 Jun 20. J Clin Oncol. 2024. PMID: 38900987 Free PMC article. Clinical Trial.
Dose exploration results from Phase 1 study of cemiplimab, a human monoclonal programmed death (PD)-1 antibody, in Japanese patients with advanced malignancies.
Kitano S, Shimizu T, Koyama T, Ebata T, Iwasa S, Kondo S, Shimomura A, Fujiwara Y, Yamamoto N, Paccaly A, Li S, Rietschel P, Sims T. Kitano S, et al. Among authors: paccaly a. Cancer Chemother Pharmacol. 2021 Jan;87(1):53-64. doi: 10.1007/s00280-020-04161-6. Epub 2020 Nov 4. Cancer Chemother Pharmacol. 2021. PMID: 33146741 Free PMC article. Clinical Trial.
Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial.
Gogishvili M, Melkadze T, Makharadze T, Giorgadze D, Dvorkin M, Penkov K, Laktionov K, Nemsadze G, Nechaeva M, Rozhkova I, Kalinka E, Gessner C, Moreno-Jaime B, Passalacqua R, Li S, McGuire K, Kaul M, Paccaly A, Quek RGW, Gao B, Seebach F, Weinreich DM, Yancopoulos GD, Lowy I, Gullo G, Rietschel P. Gogishvili M, et al. Among authors: paccaly a. Nat Med. 2022 Nov;28(11):2374-2380. doi: 10.1038/s41591-022-01977-y. Epub 2022 Aug 25. Nat Med. 2022. PMID: 36008722 Free PMC article. Clinical Trial.
Safety and Immune Responses Following Anti-PD-1 Monoclonal Antibody Infusions in Healthy Persons With Human Immunodeficiency Virus on Antiretroviral Therapy.
Gay CL, Bosch RJ, McKhann A, Cha R, Morse GD, Wimbish CL, Campbell DM, Moseley KF, Hendrickx S, Messer M, Benson CA, Overton ET, Paccaly A, Jankovic V, Miller E, Tressler R, Li JZ, Kuritzkes DR, Macatangay BJC, Eron JJ, Hardy WD; A5370 Team. Gay CL, et al. Among authors: paccaly a. Open Forum Infect Dis. 2024 Jan 11;11(3):ofad694. doi: 10.1093/ofid/ofad694. eCollection 2024 Mar. Open Forum Infect Dis. 2024. PMID: 38449916 Free PMC article. Clinical Trial.
Population pharmacokinetics modeling and exposure-response analyses of cemiplimab in patients with recurrent or metastatic cervical cancer.
Nguyen JH, Epling D, Dolphin N, Paccaly A, Conrado D, Davis JD, Al-Huniti N. Nguyen JH, et al. Among authors: paccaly a. CPT Pharmacometrics Syst Pharmacol. 2022 Nov;11(11):1458-1471. doi: 10.1002/psp4.12855. Epub 2022 Oct 17. CPT Pharmacometrics Syst Pharmacol. 2022. PMID: 36251220 Free PMC article. Clinical Trial.
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