Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04505826 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
A Phase 1 study, sponsored by Olema Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 153
- Enrollment target
NCT04505826: Completed Phase 1 study, sponsored by Olema Pharmaceuticals.
NCT04505826 is a Phase 1 study that has completed, run by Olema Pharmaceuticals. The registered enrollment target is 153 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (155% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04505826, a Phase 1 study, has completed, sponsored by Olema Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 153 participants
- Enrollment target
Study Summary
This clinical trial is a Phase I dose escalation and dose expansion and Phase II monotherapy open-label, first-in-human, multicenter study of OP-1250 in adult subjects with advanced and/or metastatic hormone receptor (HR)-positive, her2-negative breast cancer.
Primary Outcome
Number of Participants with Dose Limiting Toxicities (DLT) during Dose Escalation Only
Interventions
- DRUG OP-1250
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2020-08-13 |
| Est. Completion | 2024-07-30 |
| Phase | Phase 1 |
What the finished NCT04505826 record still lists
NCT04505826 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (155% higher).
The record links to 0 conditions, and to 1 intervention - of which OP-1250 is the first listed.
NCT04505826 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04505826 about?
NCT04505826 is a clinical study titled "A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer". This clinical trial is a Phase I dose escalation and dose expansion and Phase II monotherapy open-label, first-in-human, multicenter study of OP-1250 in adult subjects with advanced and/or metastatic hormone receptor (HR)-positive, her2-negative breast cancer.
What is the current status of trial NCT04505826?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 153 participants. The study started on 2020-08-13. Estimated completion is 2024-07-30.
What interventions are being tested in trial NCT04505826?
The interventions under investigation include: OP-1250 (DRUG).
Who is sponsoring clinical trial NCT04505826?
This trial is sponsored by Olema Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04505826's enrollment target sits among peer trials
153 358th of 2000 higher than 1,642 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05283265 · 153 participants · NA
Neurophysiological Mechanisms of Language Comprehension
- NCT05554393 · 153 participants · Phase 2
Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)
- NCT05584501 · 153 participants · NA
ETE Interventions in the Dental Setting
- NCT05714839 · 153 participants · Phase 1
A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI