Clinical Trials in France / NCT06476808
Recruiting
Phase 1
A Study to Evaluate the Safety, Tolerability, and Efficacy of Escalating Doses of BMS-986463 in Participants With Select Advanced Malignant Tumors.
NCT06476808 · tracked via the Priya Life Science France tracker
Condition(s) studied
High-grade Serous Ovarian Carcinoma (HGSOC)Uterine Serous Carcinoma (USC)Non-small Cell Lung Cancer (NSCLC)
Investigational drug(s) / intervention(s)
BMS-986463
BMS-986463: Specified dose on specified days
Study summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of escalating doses of BMS-986463 in participants with select advanced malignant tumors.
Eligibility
Inclusion Criteria
* Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
* Participants must have at least 1 lesion accessible for biopsy in addition to the target lesion, from which a fresh pre treatment biopsy must be obtained.
* Participants must have an unresectable/metastatic carcinoma.
Exclusion Criteria
* Participants must not have Leptomeningeal metastases.
* Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.
* Participants must not have had any prior radiation therapy within 2 weeks prior to start of study treatment.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Primary outcome measure(s)
- Number of participants with adverse events (AEs) — Up to 108 weeks
- Number of participants with serious adverse events (SAEs) — Up to 108 weeks
- Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria — Up to 108 weeks
- Number of participants with AEs leading to discontinuation — Up to 108 weeks
- Number of participants with AEs leading to death — Up to 108 weeks
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | Recruiting |
| Valkyrie Clinical Trials | Los Angeles | California | Recruiting |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | Recruiting |
| Local Institution - 0045 | Columbus | Ohio | Not Yet Recruiting |
| Local Institution - 0046 | Dallas | Texas | Withdrawn |
| Local Institution - 0049 | Houston | Texas | Not Yet Recruiting |
| BC Cancer Vancouver | Vancouver | British Columbia | Recruiting |
| Princess Margaret Cancer Centre | Toronto | Ontario | Recruiting |
| Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | Recruiting |
| Jewish General Hospital | Montreal | Quebec | Recruiting |
| Local Institution - 0036 | Bordeaux | Aquitaine | Not Yet Recruiting |
| Local Institution - 0031 | Villejuif | Val-de-Marne | Not Yet Recruiting |
| Local Institution - 0035 | Lyon | France | Not Yet Recruiting |
| Local Institution - 0033 | Milan | Italy | Not Yet Recruiting |
| Local Institution - 0032 | Milan | Italy | Not Yet Recruiting |
| Local Institution - 0042 | Barcelona | Barcelona [Barcelona] | Not Yet Recruiting |
| Local Institution - 0041 | Avda.Pio XII 36, | Spain | Not Yet Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06476808 on ClinicalTrials.gov ↗ ← All trials in France