drugset / Trial / NCT05703555
INTRUSION: Unraveling the INTRatUmoral PK/PD relatION for SAR408701
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tusamitamab ravtansine | Other / unclassified | 100 mg/m2 | Intravenous |