Clinical trial · no report yet · Phase 1
NCT02099058
A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors
- NCT02099058 ↗
- Active, not recruiting
- AbbVie
- Focused
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| X threads | 2 | |
| Bluesky threads | 1 |
The trial
ClinicalTrials.gov- Official title
- A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
- Phase
- Phase 1
- Status
- Active, not recruiting
- Conditions
- Advanced Solid Tumors Cancer
- Interventions
- Osimertinib; Nivolumab; Telisotuzumab vedotin; Telisotuzumab vedotin; Erlotinib
- Arms
- Monotherapy Telisotuzumab vedotin (21-day dosing cycles) · Experimental
- Monotherapy Telisotuzumab vedotin(28-day dosing cycles) · Experimental
- Monotherapy Expansion Cohort · Experimental
- Arm A (Telisotuzumab vedotin plus Erlotinib) · Experimental
- Arm D (Telisotuzumab vedotin plus Nivolumab) · Experimental
- Arm E (Telisotuzumab vedotin plus Osimertinib) · Experimental
- Enrollment
- 237
- Primary outcomes
- Number of Participants with Adverse Events
- Recommended Phase 2 Dose (RPTD) of ABBV-399 when Administered as Monotherapy and in Combination with Osimertinib, Erlotinib or Nivolumab
- Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)
- Maximum observed plasma concentration (Cmax)
- Time to Cmax (Tmax)
- Terminal elimination half life
- Sponsor
- AbbVie
- Start
- Jan 15, 2014
- Primary completion
- Aug 2026 (estimated)
- Results posted
- No
- Registry record
- NCT02099058 · updated Aug 14, 2025
Publications
linked from the registry- 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. PubMed 39805351
- 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. PubMed 36288547
- 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. PubMed 34426443
- 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. PubMed 30285518