drugset / Trial / NCT05703555

INTRUSION: Unraveling the INTRatUmoral PK/PD relatION for SAR408701

NCT05703555

NaSingle-groupOpen-labelTreatment

Summary

This study is a prospective, open-label, multi-cohort, exploratory phase II clinical trial in patients with either CEACAM5-positive NSQ NSCLC, ER+ breast cancer or gastric cancer. Eligible subjects will receive Tusamitamab ravtansine (100mg/m2 IV Q2W). The investigators hypothesize that intratumoral exposure of Tusamitamab ravtansine would be an important factor in determining treatment efficacy. Combining exposure with measurements of tumor PD reactions in a proper PK/PD study is the goal of this study.

Timeline

Start
2024-02-16
Primary completion
2024-02-16
Completion
2024-02-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Tusamitamab ravtansine Other / unclassified 100 mg/m2 Intravenous