drugset / Trial / NCT05491083
Pembrolizumab and ADG106 in Advanced Solid Cancers and Triple Negative Breast Cancer
Phase 1/2
Recruiting
51 enrolled
National University Hospital, Singapore
Adagene Inc · collabMerck Sharp & Dohme LLC · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a phase Ib followed by phase II clinical trial evaluating the safety and efficacy of combination of ADG106 with pembrolizumab in patients with metastatic cancers. The Phase Ib dose finding part will include all solid tumor subtypes with treatment refractory disease, while phase II will focus on only patients with TNBC.
Timeline
- Start
- 2023-06-12
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
Publications
- Results Caswell-Jin JL, Plevritis SK, Tian L, Cadham CJ, Xu C, Stout NK, Sledge GW, Mandelblatt JS, Kurian AW. Change in Survival in Metastatic Breast Cancer with Treatment Advances: Meta-Analysis and Systematic Review. JNCI Cancer Spectr. 2018 Nov;2(4):pky062. doi: 10.1093/jncics/pky062. Epub 2018 Dec 24.
- Results Skinner KE, Haiderali A, Huang M, Schwartzberg LS. Real-world effectiveness outcomes in patients diagnosed with metastatic triple-negative breast cancer. Future Oncol. 2021 Mar;17(8):931-941. doi: 10.2217/fon-2020-1021. Epub 2020 Nov 19.
- Results Fossati R, Confalonieri C, Torri V, Ghislandi E, Penna A, Pistotti V, Tinazzi A, Liberati A. Cytotoxic and hormonal treatment for metastatic breast cancer: a systematic review of published randomized trials involving 31,510 women. J Clin Oncol. 1998 Oct;16(10):3439-60. doi: 10.1200/JCO.1998.16.10.3439.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ADG106 | Monoclonal antibody | — | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | — | Intravenous |