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INTRUSION: Unraveling the INTRatUmoral PK/PD relatION for SAR408701

NCT05703555 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-02-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Tusamitamab ravtansine

Eligible subjects will receive Tusamitamab ravtansine (100mg/m2 IV Q2W). Subjects without evidence of disease progression or drug related toxicity can continue treatment with Tusamitamab ravtansine (100 mg/m2 IV Q2W) until disease progression, unacceptable toxicity occurs, or the participant's or Investigator's decision to stop the treatment.

Sponsors & Collaborators

Principal Investigators

  • Debbie Robbrecht, Dr. · Erasmus Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05703555 on ClinicalTrials.gov