PROCLAIM-CX-072: A Trial to Find Safe and Active Doses of an Investigational Drug CX-072 for Patients With Solid Tumors or Lymphomas
Summary
The purpose of this first-in-human study of CX-072 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-072 administered intravenously (IV) as a single agent or in combination with ipilimumab or vemurafenib in adult subjects with advanced or recurrent solid tumors or lymphomas. PROCLAIM-CX-072: PRObody CLinical Assessment In Man CX-072 clinical trial CX-072 is a Probody® therapeutic directed against PD-L1 (programmed cell death ligand 1). Probody therapeutics are proteolytically-activatable antibodies (Abs) designed to widen the therapeutic index by minimizing drug interaction with normal tissue while retaining anti-tumor activity. Probody therapeutics are "masked" to attenuate binding to target in healthy tissue but can become "unmasked" in the tumor microenvironment by tumor-specific protease activity. PROBODY is a U.S. registered trademark of CytomX Therapeutics, Inc.
Timeline
- Start
- 2017-01-19
- Primary completion
- 2020-10-27
- Completion
- 2020-10-27
Publications
- Naing A, Thistlethwaite F, De Vries EGE, Eskens FALM, Uboha N, Ott PA, LoRusso P, Garcia-Corbacho J, Boni V, Bendell J, Autio KA, Randhawa M, Durm G, Gil-Martin M, Stroh M, Hannah AL, Arkenau HT, Spira A. CX-072 (pacmilimab), a Probody (R) PD-L1 inhibitor, in advanced or recurrent solid tumors (PROCLAIM-CX-072): an open-label dose-finding and first-in-human study. J Immunother Cancer. 2021 Jul;9(7):e002447. doi: 10.1136/jitc-2021-002447.
- Sanborn RE, Hamid O, de Vries EG, Ott PA, Garcia-Corbacho J, Boni V, Bendell J, Autio KA, Cho DC, Plummer R, Stroh M, Lu L, Thistlethwaite F. CX-072 (pacmilimab), a Probody PD-L1 inhibitor, in combination with ipilimumab in patients with advanced solid tumors (PROCLAIM-CX-072): a first-in-human, dose-finding study. J Immunother Cancer. 2021 Jul;9(7):e002446. doi: 10.1136/jitc-2021-002446.
- Giesen D, Broer LN, Lub-de Hooge MN, Popova I, Howng B, Nguyen M, Vasiljeva O, de Vries EGE, Pool M. Probody Therapeutic Design of 89Zr-CX-072 Promotes Accumulation in PD-L1-Expressing Tumors Compared to Normal Murine Lymphoid Tissue. Clin Cancer Res. 2020 Aug 1;26(15):3999-4009. doi: 10.1158/1078-0432.CCR-19-3137. Epub 2020 Jan 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Ipilimumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Ipilimumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Pacmilimab | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | Pacmilimab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Pacmilimab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Pacmilimab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Vemurafenib | Small molecule | — | — |