drugset / Trial / NCT05245071

Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA

NCT05245071

Phase 2 Terminated 22 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

Summary

This is an open label single group, Phase 2, 1-arm study for treatment to evaluate efficacy, safety, and Pharmacokinetic (PK) of tusamitamab ravtansine in nonsquamous non-small-cell-lung-cancer (NSQ NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating carcinoembryonic antigen (CEA). Participants who will be enrolled, will receive tusamitamab ravtansine as monotherapy every two weeks (Q2W) until disease progression, unacceptable adverse event (AE), initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment, whichever comes first. A total of approximately 38 participants are planned to be treated.

Timeline

Start
2022-06-01
Primary completion
2024-03-06
Completion
2024-11-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Tusamitamab ravtansine Other / unclassified Intravenous