First-in-man Dose Escalation Study of BAY2010112 in Patients With Prostate Cancer

Summary

This is the first study where BAY2010112 is given to humans. Patients with castration resistant prostate cancer will be treated. Every patient will receive drug treatment, there is no placebo group. Patients will receive different dosages of BAY2010112 to determine the safety, tolerability and maximum tolerated dose (MTD) of BAY2010112. The study will also assess the pharmacokinetics and the clinical efficacy of BAY2010112. BAY2010112 will be given daily as subcutaneous injection or as continuous intravenous infusion. Treatment will be stopped if the tumor continues to grow, if side effects, which the patient cannot tolerate, occur or if the patient decides to exit treatment.

Timeline

Start

2012-11-02

Primary completion

2018-07-18

Completion

2018-09-26

Publications

• Results Frankel SR, Baeuerle PA. Targeting T cells to tumor cells using bispecific antibodies. Curr Opin Chem Biol. 2013 Jun;17(3):385-92. doi: 10.1016/j.cbpa.2013.03.029. Epub 2013 Apr 25.
• Penny HL, Hainline K, Theoharis N, Wu B, Brandl C, Webhofer C, McComb M, Wittemer-Rump S, Koca G, Stienen S, Bargou RC, Hummel HD, Loidl W, Grullich C, Eggert T, Tran B, Mytych DT. Characterization and root cause analysis of immunogenicity to pasotuxizumab (AMG 212), a prostate-specific membrane antigen-targeting bispecific T-cell engager therapy. Front Immunol. 2023 Oct 23;14:1261070. doi: 10.3389/fimmu.2023.1261070. eCollection 2023.
• Hummel HD, Kufer P, Grullich C, Seggewiss-Bernhardt R, Deschler-Baier B, Chatterjee M, Goebeler ME, Miller K, de Santis M, Loidl W, Dittrich C, Buck A, Lapa C, Thurner A, Wittemer-Rump S, Koca G, Boix O, Docke WD, Finnern R, Kusi H, Ajavon-Hartmann A, Stienen S, Sayehli CM, Polat B, Bargou RC. Pasotuxizumab, a BiTE(R) immune therapy for castration-resistant prostate cancer: Phase I, dose-escalation study findings. Immunotherapy. 2021 Feb;13(2):125-141. doi: 10.2217/imt-2020-0256. Epub 2020 Nov 10.

Drugs

Indications