A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR)

Summary

This is an open-label, Phase 1, dose-escalation study to determine the maximum tolerated dose (MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of ABBV-321 for participants with advanced solid tumors likely to overexpress the epidermal growth factor receptor (EGFR). The study will consist of 2 phases: Dose Escalation Phase and Expansion Phase.

Timeline

Start

2017-10-10

Primary completion

2021-04-14

Completion

2021-04-14

Publications

• Carneiro BA, Papadopoulos KP, Strickler JH, Lassman AB, Waqar SN, Chae YK, Patel JD, Shacham-Shmueli E, Kelly K, Khasraw M, Bestvina CM, Merrell R, Huang K, Atluri H, Ansell P, Li R, Jin J, Anderson MG, Reilly EB, Morrison-Thiele G, Patel K, Robinson RR, Aristide MRN, Gan HK. Phase I study of anti-epidermal growth factor receptor antibody-drug conjugate serclutamab talirine: Safety, pharmacokinetics, and antitumor activity in advanced glioblastoma. Neurooncol Adv. 2022 Dec 21;5(1):vdac183. doi: 10.1093/noajnl/vdac183. eCollection 2023 Jan-Dec.

Drugs

Indications

No indication recorded.