drugset / Trial / NCT02315066
Study Of OX40 Agonist PF-04518600 Alone And In Combination With 4-1BB Agonist PF-05082566
Non-randomizedSingle-groupOpen-labelTreatment
Summary
To assess the safety and tolerability at increasing dose levels of PF-04518600 alone or in combination wtih PF-05082566 in patients with select advanced or metastatic carcinoma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Timeline
- Start
- 2015-04-23
- Primary completion
- 2020-11-12
- Completion
- 2020-11-12
Publications
- Hamid O, Chiappori AA, Thompson JA, Doi T, Hu-Lieskovan S, Eskens FALM, Ros W, Diab A, Spano JP, Rizvi NA, Wasser JS, Angevin E, Ott PA, Forgie A, Yang W, Guo C, Chou J, El-Khoueiry AB. First-in-human study of an OX40 (ivuxolimab) and 4-1BB (utomilumab) agonistic antibody combination in patients with advanced solid tumors. J Immunother Cancer. 2022 Oct;10(10):e005471. doi: 10.1136/jitc-2022-005471.
- Diab A, Hamid O, Thompson JA, Ros W, Eskens FALM, Doi T, Hu-Lieskovan S, Klempner SJ, Ganguly B, Fleener C, Wang X, Joh T, Liao K, Salek-Ardakani S, Taylor CT, Chou J, El-Khoueiry AB. A Phase I, Open-Label, Dose-Escalation Study of the OX40 Agonist Ivuxolimab in Patients with Locally Advanced or Metastatic Cancers. Clin Cancer Res. 2022 Jan 1;28(1):71-83. doi: 10.1158/1078-0432.CCR-21-0845. Epub 2021 Oct 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ivuxolimab | Monoclonal antibody | 0.01 mg/kg | Intravenous |
| Subject | Ivuxolimab | Monoclonal antibody | 0.1 mg/kg | Intravenous |
| Subject | Ivuxolimab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Ivuxolimab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Ivuxolimab | Monoclonal antibody | 30 mg | Intravenous |
| Subject | Utomilumab | Monoclonal antibody | 20 mg | Intravenous |
| Subject | Utomilumab | Monoclonal antibody | 100 mg | Intravenous |