Clinical trial · Interventional
Study of AVE1642 (IGF-1R/CD221) in Combination With Fulvestrant (Faslodex®) in Postmenopausal Patients With Advanced Hormono-dependent Breast Cancer
Multicenter, Randomized, Open Label Study Evaluating an Anti Insulin-like Growth Factor-1 Receptor (IGF-1R/CD221) Monoclonal Antibody, AVE1642, Administered Every 4 Weeks in Combination With Fulvestrant (Faslodex®) in Postmenopausal Patients With Advanced Hormono-dependent Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Company decision to discontinue the AVE1642 development program, not due to any safety or efficacy concerns
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the clinical activity of AVE1642 in combination with fulvestrant and of fulvestrant alone in terms of clinical benefit as the rate of "complete response", "partial response" and "stabilization of the disease". The additional objectives are to evaluate the safety profile of AVE1642 in combination with fulvestrant and of fulvestrant alone, to assess the rate of patients without disease progression at 6 months and the overall progression-free survival time. An evaluation of the pharmacokinetics and pharmacodynamics interactions between AVE1642 and fulvestrant will also be performed. The biological activity of treatment will be assessed on tumor biopsies, when possible The potential immunogenicity of AVE1642 will be studied
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AVE1642 | Drug | — | UNRESOLVED |
| Fulvestrant | Drug | Fulvestrant | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- interventionNames
- Drug: AVE1642
- Drug: Fulvestrant
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- interventionNames
- Drug: Fulvestrant
Primary outcomes (1)
- measure
- Clinical benefit defined as a confirmed complete response (CR) or a confirmed partial response (PR) or a stable disease (SD)lasting at least 24 weeks (6 cycles)
- timeFrame
- 6 cycles
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Post-menopausal women * Aromatase inhibitor as the last hormonal treatment * Breast adenocarcinoma with positive hormone receptor * Measurable disease as per RECIST definition Exclusion Criteria: * ECOG performance status (PS) \> 2 * Prior exposure to fulvestrant or to an anti IGF-1R compound * No evidence of hormonosensitivity * HER 2-neu positive tumor * More than one prior regimen of chemotherapy for metastatic disease The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (0)
Data not yet available