drugset / Trial / NCT02099058
A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-399 as monotherapy and in combination with osimertinib, erlotinib, and nivolumab in participants with advanced solid tumors likely to express c-Met. Enrollment is closed for the monotherapy arms, Arm A, and Arm D.
Timeline
- Start
- 2014-01-15
- Primary completion
- 2026-08
- Completion
- 2026-08
Publications
- Horinouchi H, Cho BC, Camidge DR, Goto K, Tomasini P, Li Y, Vasilopoulos A, Brunsdon P, Hoffman D, Shi W, Bolotin E, Blot V, Goldman J. Results from a phase Ib study of telisotuzumab vedotin in combination with osimertinib in patients with c-Met protein-overexpressing, EGFR-mutated locally advanced/metastatic non-small-cell lung cancer (NSCLC) after progression on prior osimertinib. Ann Oncol. 2025 May;36(5):583-591. doi: 10.1016/j.annonc.2025.01.001. Epub 2025 Jan 11.
- Camidge DR, Barlesi F, Goldman JW, Morgensztern D, Heist R, Vokes E, Spira A, Angevin E, Su WC, Hong DS, Strickler JH, Motwani M, Dunbar M, Parikh A, Noon E, Blot V, Wu J, Kelly K. Phase Ib Study of Telisotuzumab Vedotin in Combination With Erlotinib in Patients With c-Met Protein-Expressing Non-Small-Cell Lung Cancer. J Clin Oncol. 2023 Feb 10;41(5):1105-1115. doi: 10.1200/JCO.22.00739. Epub 2022 Oct 26.
- Camidge DR, Morgensztern D, Heist RS, Barve M, Vokes E, Goldman JW, Hong DS, Bauer TM, Strickler JH, Angevin E, Motwani M, Parikh A, Sun Z, Bach BA, Wu J, Komarnitsky PB, Kelly K. Phase I Study of 2- or 3-Week Dosing of Telisotuzumab Vedotin, an Antibody-Drug Conjugate Targeting c-Met, Monotherapy in Patients with Advanced Non-Small Cell Lung Carcinoma. Clin Cancer Res. 2021 Nov 1;27(21):5781-5792. doi: 10.1158/1078-0432.CCR-21-0765. Epub 2021 Aug 23.
- Strickler JH, Weekes CD, Nemunaitis J, Ramanathan RK, Heist RS, Morgensztern D, Angevin E, Bauer TM, Yue H, Motwani M, Parikh A, Reilly EB, Afar D, Naumovski L, Kelly K. First-in-Human Phase I, Dose-Escalation and -Expansion Study of Telisotuzumab Vedotin, an Antibody-Drug Conjugate Targeting c-Met, in Patients With Advanced Solid Tumors. J Clin Oncol. 2018 Nov 20;36(33):3298-3306. doi: 10.1200/JCO.2018.78.7697. Epub 2018 Oct 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erlotinib | Small molecule | 150 mg | Oral |
| Subject | Nivolumab | Monoclonal antibody | — | Intravenous |
| Subject | Osimertinib | Small molecule | 80 mg | — |
| Subject | Telisotuzumab Vedotin | Monoclonal antibody | 0.15 mg/kg | Intravenous |
| Subject | Telisotuzumab Vedotin | Monoclonal antibody | 1.6 mg/kg | Intravenous |
| Subject | Telisotuzumab Vedotin | Monoclonal antibody | 1.9 mg/kg | Intravenous |
| Subject | Telisotuzumab Vedotin | Monoclonal antibody | 2.2 mg/kg | Intravenous |
| Subject | Telisotuzumab Vedotin | Monoclonal antibody | 2.4 mg/kg | Intravenous |
| Subject | Telisotuzumab Vedotin | Monoclonal antibody | 2.7 mg/kg | Intravenous |
| Subject | Telisotuzumab Vedotin | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Telisotuzumab Vedotin | Monoclonal antibody | 3.3 mg/kg | Intravenous |
Indications
No indication recorded.