INTRUSION: Unraveling the INTRatUmoral PK/PD relatION for SAR408701 (NCT05703555) | Clinical Trial Compass
WithdrawnPhase 2
INTRUSION: Unraveling the INTRatUmoral PK/PD relatION for SAR408701
Stopped: Due to the decision to discontinue the global clinical development program of tusamitamab ravtansine
Netherlands0Started 2024-02-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients (≥ 18y) at the time of signing the Informed Consent Form (ICF).
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Estimated life expectancy ≥ 3 months
* Expression of CEACAM5 established by an IHC assay of ≥2+ in intensity involving at least 50% of the tumor cell population in archival tumor sample (or, if not available, a fresh biopsy sample) at a metastatic site (mandatory) including distant lymph nodes.
* Either: Metastatic or irresectable Non-Squamous Non-Small Cell Lung Cancer without EGFR/ALK/ROS aberration, as diagnosed by histological evaluation, after chemotherapy (restricted to 1 line of platinum-based chemotherapy) and immunotherapy (not more than 1 line). These therapies may have been applied concurrent or sequential; Or: Metastatic ER+ breast cancer, pathologically confirmed. ER+ is defined as ≥1% tumor staining by IHC. Participants must be no longer eligible for hormonal therapy. Participants may have had at maximum 1 prior systemic chemotherapy line.
A chemotherapy line in advanced/metastatic disease is an anti-cancer regimen that contains at least 1 cytotoxic chemotherapy agent and was discontinued due to progression. If a cytotoxic chemotherapy regimen was discontinued for a reason other than disease progression then this regimen does not count as a "prior line of chemotherapy" unless this regimen was discontinued after at least 2 cycles of treatment.
Or: Metastatic gastric cancer, pathologically conf…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
intratumoral DM4 concentration
Timeframe: approximately 5 weeks, more specific day 3 of cycle 2 (each cycle is 14 days)