Clinical trial · Interventional
Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers
A Phase I/Ib, Open Label Study of LSZ102 Single Agent and LSZ102 in Combination With Either LEE011 (LSZ102 + LEE011) or BYL719 (LSZ102 + BYL719) in Patients With Advanced or Metastatic ER+ Breast Cancer Who Have Progressed After Endocrine Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor's decision
Summary
Brief summary (as posted)
To characterize the safety and tolerability, identify recommended doses and regimens for future studies, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LSZ102 as a single agent and in combination with either LEE011 or BYL719 in adult patients with locally advanced or metastatic ER+ breast cancer who have progressed after endocrine therapy.
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 |
|---|---|---|---|
| Advanced or Metastatic ER+ Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BYL719 | Drug | Alpelisib | ALIAS |
| LEE011 | Drug | Ribociclib | ALIAS |
| LSZ102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Patients will get LSZ102 single agent during dose escalation.
- interventionNames
- Drug: LSZ102
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Patients will get LSZ102 in combination with LEE011 during dose escalation.
- interventionNames
- Drug: LSZ102
- Drug: LEE011
- type
- EXPERIMENTAL
- label
- Arm C
- description
- Patients will get LSZ102 in combination with BYL719 during dose escalation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent must be obtained prior to any procedures * Histologically and/or cytologically confirmed diagnosis of ER+/HER2- breast cancer * Advanced or metastatic breast cancer * Must be able to swallow tablets and capsules Exclusion Criteria: * Symptomatic CNS metastases * Patients whose laboratory values do not meet protocol criteria * Clinically significant cardiac disease * Impaired gastrointestinal function (GI) or GI disease that may significantly alter the absorption of oral medications Other protocol defined inclusion/exclusion criteria may apply.
References
Publications (1)
- RESULTJhaveri K, Juric D, Yap YS, Cresta S, Layman RM, Duhoux FP, Terret C, Takahashi S, Huober J, Kundamal N, Sheng Q, Balbin A, Ji Y, He W, Crystal A, De Vita S, Curigliano G. A Phase I Study of LSZ102, an Oral Selective Estrogen Receptor Degrader, with or without Ribociclib or Alpelisib, in Patients with Estrogen Receptor-Positive Breast Cancer. Clin Cancer Res. 2021 Nov 1;27(21):5760-5770. doi: 10.1158/1078-0432.CCR-21-1095. Epub 2021 Aug 25. PMID 34433648