Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Ex… (NCT05013554) | Clinical Trial Compass
TerminatedPhase 1
Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors
United States, Belgium, France44 participantsStarted 2021-08-16
Plain-language summary
Primary Objectives:
Part 1 (Dose Escalation)
* To determine the MTD/maximum administered dose (MAD) of SAR443216 administered as a single agent in participants with HER2 expressing solid tumors and determine the RD(s) for intravenous (IV) and subcutaneous (SC) administration in the dose escalation part.
* To determine the safety of SAR443216 after intravenous (IV) and subcutaneous (SC) administration.
Part 2 (Dose expansion)
• To assess preliminary clinical activity of single agent SAR443216 at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression.
Secondary Objectives:
Part 1 • To assess preliminary clinical activity of single agent SAR443216 after IV and SC administration at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression.
Part 2
• To determine the safety of SAR443216.
Part 1 and 2
* To characterize the pharmacokinetic (PK) profile of SAR443216 when administered as a single agent after IV and SC (Part 1 only) administration.
* To evaluate the immunogenicity of SAR443216 after IV and SC administration.
* To assess preliminary clinical activity of single agent SAR443216 at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression.
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:
* Participants must be ≥ 18 years of age
* Histologically or cytologically confirmed diagnosis of metastatic solid tumors
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* All participants should have at least 1 measurable disease per RECIST v1.1. An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion.
* Body weight within \[45 - 150 kg\] (inclusive)
* All Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Capable of giving signed informed consent
Exclusion Criteria:
* Any clinically significant cardiac disease
* History of or current interstitial lung disease or pneumonitis
* Uncontrolled or unresolved acute renal failure
* Prior solid organ or hematologic transplant.
* Known positivity with human immunodeficiency virus (HIV), known active hepatitis A, B, and C, or uncontrolled chronic or ongoing infectious requiring parenteral treatment.
* Receipt of a live-virus vaccination within 28 days of planned treatment start
* Participation in a concurrent clinical study in the treatment period.
* Inadequate hematologic, hepatic and renal function
* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions.
The above information is not intended to contain all considerations relevant to the …
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
Part 1: Dose Escalation Determine the MTD/maximum administered dose (MAD) and RD(s) of SAR443216
Timeframe: Cycle 1, cycle duration is 28 days for 2-week lead-in schedule and 35 days for 3-week lead-in schedule
2
Part 1: Dose Escalation: Safety of SAR443216
Timeframe: Baseline until end of study, up to approximately 7.5 months
3
Part 2: Dose Expansion Objective response rate (ORR) of SAR443216 in all participants
Timeframe: From date of enrollment until the end of treatment, up to approximately 5.5 months
4
Part 2: Dose Expansion Duration of response (DoR) of SAR443216 in all participants.
Timeframe: From date of enrollment until the end of treatment, up to approximately 5.5 months