drugset / Trial / NCT05162755
S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers
Non-randomizedSequentialOpen-labelTreatment
Summary
The purpose of the study is to investigate the safety, tolerability, and preliminary anti-neoplastic activity of S095029 alone and in combination with Sym021 in patients with advanced solid tumor malignancies followed by an expansion phase of triple combinations. \*The study sponsor has made the decision not to move forward to the expansion part of the study due to strategic considerations, unrelated to any safety issues or concerns. The study will be stopped after completion of dose escalation parts 1a and 1b of the study.
Timeline
- Start
- 2021-10-15
- Primary completion
- 2024-02-01
- Completion
- 2026-05-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | S095029 | Monoclonal antibody | 10 mg | Intravenous |
| Subject | S095029 | Monoclonal antibody | 30 mg | Intravenous |
| Subject | S095029 | Monoclonal antibody | 100 mg | Intravenous |
| Subject | S095029 | Monoclonal antibody | 300 mg | Intravenous |
| Subject | S095029 | Monoclonal antibody | 750 mg | Intravenous |
| Subject | S095029 | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Sym021 | Monoclonal antibody | 200 mg | — |