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

NCT05162755

Phase 1 Completed 41 enrolled Servier ADIR, a Servier Group company · collab
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

EvaluationDrugModalityDoseRoute
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

Indications