OncoMatch/Clinical Trials/NCT05868226
PRE-ISPY Phase I/II Oncology Platform Program
Is NCT05868226 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments for her2-positive breast cancer.
Treatment: ALX148 · Fam-Trastuzumab Deruxtecan-Nxki · Zanidatamab · Tucatinib · TTX-MC138 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Breast Carcinoma
Tumor Agnostic
Triple-Negative Breast Cancer
Colorectal Cancer
Disease stage
Metastatic disease required
Metastatic Cancer; Metastatic Breast Cancer; Metastatic
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,500/mm3; Platelet count ≥ 100,000/mm3; Hemoglobin ≥ 9.0 g/dL with no blood transfusion in the past 28 days
Kidney function
Estimated Creatinine clearance (Cockcroft-Gault) ≥ 60 mL/min for small molecules and >30 mL/min for monoclonal antibodies unless otherwise specified
Liver function
Total bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 3.0 x ULN
Cardiac function
QTcF length > 470 msec for men and women (history of clinically significant cardiovascular disease within 6 months prior to start IMP: unstable angina, CHF, MI, uncontrolled hypertension, arrhythmia requiring medication)
Adequate organ function, evidenced by the following laboratory results within 30 days of the start of IMP: Absolute neutrophil count ≥ 1,500/mm3; Platelet count ≥ 100,000/mm3; Hemoglobin ≥ 9.0 g/dL with no blood transfusion in the past 28 days; Total bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 3.0 x ULN; Estimated Creatinine clearance (Cockcroft-Gault) ≥ 60 mL/min for small molecules and >30 mL/min for monoclonal antibodies unless otherwise specified. Cardiovascular disease: History (within 6 months prior to start IMP) of clinically significant cardiovascular disease such as unstable angina, CHF, MI, uncontrolled hypertension, arrhythmia requiring medication, or baseline corrected QT by Fridericia's formula (QTcF) length > 470 msec for men and women.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Alabama at Birmingham O'Neal Comprehensive Cancer Center · Birmingham, Alabama
- Mayo Clinic Comprehensive Cancer Center · Phoenix, Arizona
- University of Colorado Cancer Center · Aurora, Colorado
- Moffitt Cancer Center · Tampa, Florida
- The University of Chicago Medicine Comprehensive Cancer Center · Chicago, Illinois
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05868226 currently recruiting?
Yes, this trial is currently recruiting patients.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify