PRE-I-SPY Phase I/Ib Oncology Platform Program
Public ClinicalTrials.gov record NCT05868226. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial
Study identification
- NCT ID
- NCT05868226
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- QuantumLeap Healthcare Collaborative
- Other
- Enrollment
- 124 participants
Conditions and interventions
Conditions
- ER Positive Breast Cancer
- Estrogen Receptor Positive Tumor
- HER-2 Protein Overexpression
- HER2 Low Breast Cancer
- HER2 Low Breast Carcinoma
- HER2 Mutation-Related Tumors
- HER2-negative Breast Cancer
- HER2-positive Breast Cancer
- HER2-positive Metastatic Breast Cancer
- HR Positive
- Hormone Receptor Negative Breast Carcinoma
- Hormone Receptor-positive Breast Cancer
- Metastatic
- Metastatic Breast Cancer
- Metastatic Cancer
- PR-positive Breast Cancer
- Progesterone Receptor-positive Breast Cancer
- Solid Carcinoma
- Solid Tumor
- Solid Tumor, Adult
- Triple Negative Breast Cancer
Interventions
- ALX148 Drug
- Fam-Trastuzumab Deruxtecan-Nxki Drug
- Tucatinib Drug
- Zanidatamab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 14, 2023
- Primary completion
- Dec 29, 2028
- Completion
- Dec 29, 2029
- Last update posted
- Apr 3, 2025
2023 – 2029
United States locations
- U.S. sites
- 7
- U.S. states
- 5
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Alabama at Birmingham O'Neal Comprehensive Cancer Center | Birmingham | Alabama | 35233 | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | 33612 | Recruiting |
| The University of Chicago Medicine Comprehensive Cancer Center | Chicago | Illinois | 60637 | Recruiting |
| UChicago Medicine Comprehensive Cancer Center at Silver Cross Hospital | New Lenox | Illinois | 60451 | Recruiting |
| UChicago Medicine Orland Park | Orland Park | Illinois | 60462 | Recruiting |
| University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota | 55455 | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05868226, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 3, 2025 · Synced May 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05868226 live on ClinicalTrials.gov.