PRE-ISPY Phase I/II 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/II Platform Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced, incurable, or metastatic solid tumors and/or oligometastatic malignancy and/or a high risk of recurrence following prior treatment with curative intent. The overall goal is moving promising drug regimens into a larger phase II (or III) trial and in general could feed the neoadjuvant breast I-SPY 2 Trial (NCT01042379) and/or other oncology solid tumor trial in a timely manner.
Study identification
- NCT ID
- NCT05868226
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 280 participants
Conditions and interventions
Conditions
- HER2-positive Breast Cancer
- Metastatic Cancer
- Metastatic Breast Cancer
- Metastatic
- HER2-positive Metastatic Breast Cancer
- HER2 Mutation-Related Tumors
- HER-2 Protein Overexpression
- HER2-negative Breast Cancer
- Triple Negative Breast Cancer
- HR Positive
- Hormone Receptor-positive Breast Cancer
- Estrogen Receptor Positive Tumor
- Progesterone Receptor-positive Breast Cancer
- Hormone Receptor Negative Breast Carcinoma
- Solid Tumor
- Solid Tumor, Adult
- Solid Carcinoma
- HER2 Low Breast Cancer
- HER2 Low Breast Carcinoma
- ER Positive Breast Cancer
- PR-positive Breast Cancer
- Minimal Residual Disease
- Colo-rectal Cancer
- Colon Cancer
- Rectal Cancer
- ctDNA Monitoring
- Colorectal Neoplasms
- Colonic Neoplasms
- Rectal Neoplasms
- Neoplasm, Residual
- Adenocarcinoma of Colon
- Adenocarcinoma
Interventions
- ALX148 Drug
- Fam-Trastuzumab Deruxtecan-Nxki Drug
- Zanidatamab Drug
- Tucatinib Drug
- TTX-MC138 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, 2030
- Completion
- Dec 29, 2031
- Last update posted
- Sep 1, 2026
2023 – 2031
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Alabama at Birmingham O'Neal Comprehensive Cancer Center | Birmingham | Alabama | 35233 | Recruiting |
| Mayo Clinic Comprehensive Cancer Center | Phoenix | Arizona | 85054 | Not yet recruiting |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | Active, not recruiting |
| Moffitt Cancer Center | Tampa | Florida | 33612 | Active, not 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 |
| Mayo Clinic Comprehensive Cancer Center | Rochester | Minnesota | 55905 | Not yet recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | Active, not 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 Sep 1, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05868226 live on ClinicalTrials.gov.