Clinical Trial

Study of ERW316 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Withdrawn Phase 1/2
View on ClinicalTrials.gov →
Why the trial stopped
Business decision
Summary
Phase I: Characterize safety and tolerability of ERW316 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation. Phase II: Further characterize the safety and tolerability of ERW316 in combination with fulvestrant in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer.
Protocol Amendment History 2 changes
critical Trial status changed: Not Yet Recruiting → Withdrawn 2026-06-23
notable Enrollment reduced: 217 -> 0 participants 2026-06-23
Trial Details
NCT Number NCT07570966
Lead Sponsor Novartis Pharmaceuticals
Conditions Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer (mCRPC)
Start Date 2026-06-30
Primary Completion 2031-08-01 (estimated)
Study Completion 2031-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-22