PRE-ISPY Phase I/II Oncology Platform Program
NCT05868226
This study is recruiting at 5 US sites in 3 states, according to its ClinicalTrials.gov record last updated .
Summary
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- 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
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 1/2
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- QuantumLeap Healthcare Collaborative
- Last updated on ClinicalTrials.gov
- September 30, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Alabama · 1
- The University of Alabama at Birmingham O'Neal Comprehensive Cancer Center · Birmingham, AL
Illinois · 3
- The University of Chicago Medicine Comprehensive Cancer Center · Chicago, IL
- UChicago Medicine Comprehensive Cancer Center at Silver Cross Hospital · New Lenox, IL
- UChicago Medicine Orland Park · Orland Park, IL
Minnesota · 1
- University of Minnesota Masonic Cancer Center · Minneapolis, MN
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.