A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
Hormone Receptor Positive Breast Carcinoma · HER2-negative Breast Cancer
No strong warning signs right now. The score counts warning signs; it is not a prediction.
Why this score
No warning signs right now. That's why the score is 0.
Score over time
- Stage
- Phase 1/2
- Patients
- 153 (final count)
- Started
- Aug 13, 2020
- Main results expected
- Jul 30, 2024
- Fully finished
- Jul 30, 2024
- Results posted
- May 11, 2026
What counts as success
The trial's main goal(s), called the “primary outcome.”
Dose Limiting Toxicities (DLT)
Measured over: Up to 28 days from start of treatment
Characterize the Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) of OP-1250 That Had at Least One Treatment Emergent Adverse Event
Measured over: Up to 3 years, 11 months, and 17 days.
Pharmacokinetics of OP-1250
Measured over: AUC (0-24) at steady state after 4 weeks of administration
Anti-tumor Activity of OP-1250 (cPR)
Measured over: Imaging studies performed every 8 weeks from date of first dose through cycle 9 then afterwards every 12 weeks until date of first documented disease progression: assessed up to 3 years, 11 months, and 17 days
Changes Tremor has spotted
Show details (technical version)
Score inputs
- none
Raw record changes
- none yet
Trial ID NCT04505826 · record last updated 2026-05-11 · checked 2026-11-09 15:47 UTC