drugset
drugset / Trial / NCT05619744

A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of RO7616789 in Advanced Small Cell Lung Cancer and Other Neuroendocrine Carcinomas

NCT05619744 ↗

Phase 1 Completed 41 enrolled Hoffmann-La Roche
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of RO7616789. The study will have 3 parts: Dose Escalation (Parts 1 and 2) and Dose Expansion (Part 3). Participants with advanced stage small cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC) will be enrolled in the study.

Timeline

Start
2023-01-23
Primary completion
2025-03-04
Completion
2025-03-04

Drugs

EvaluationDrugModalityDoseRoute
Subject RO7616789 Unknown — Intravenous
Background Tocilizumab Monoclonal antibody 8 mg/kg Intravenous
Background Tocilizumab Monoclonal antibody 12 mg/kg Intravenous

Indications

small cell lung carcinoma