OncoMatch/Clinical Trials/NCT05868226
PRE-I-SPY Phase I/Ib Oncology Platform Program
Is NCT05868226 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including ALX148 and Fam-Trastuzumab Deruxtecan-Nxki for her2-positive breast cancer.
Treatment: ALX148 · Fam-Trastuzumab Deruxtecan-Nxki · Zanidatamab · Tucatinib — I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Tumor Agnostic
Triple-Negative Breast 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 [excluded]; history (within 6 months) of clinically significant cardiovascular disease such as unstable angina, CHF, MI, uncontrolled hypertension, cardiac 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. QTcF length > 470 msec for men and women [excluded]; history (within 6 months) of clinically significant cardiovascular disease such as unstable angina, CHF, MI, uncontrolled hypertension, cardiac arrhythmia requiring medication
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
- Moffitt Cancer Center · Tampa, Florida
- The University of Chicago Medicine Comprehensive Cancer Center · Chicago, Illinois
- UChicago Medicine Comprehensive Cancer Center at Silver Cross Hospital · New Lenox, Illinois
- UChicago Medicine Orland Park · Orland Park, Illinois
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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