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PRE-I-SPY Phase I/Ib Oncology Platform Program
NCT05868226 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Tucatinib
- DRUG Zanidatamab
- DRUG ALX148
- DRUG Fam-Trastuzumab Deruxtecan-Nxki
Study Locations (7)
Illinois
- The University of Chicago Medicine Comprehensive Cancer Center — Chicago
- UChicago Medicine Comprehensive Cancer Center at Silver Cross Hospital — New Lenox
- UChicago Medicine Orland Park — Orland Park
Alabama
- The University of Alabama at Birmingham O'Neal Comprehensive Cancer Center — Birmingham
Florida
- Moffitt Cancer Center — Tampa
Minnesota
- University of Minnesota Masonic Cancer Center — Minneapolis
Texas
- The University of Texas MD Anderson Cancer Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2023-02-15 |
| Est. Completion | 2029-12-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05868226
The ClinicalTrials.gov registry entry for NCT05868226 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is QuantumLeap Healthcare Collaborative, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 4 interventions — of which Tucatinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05868226 reports 7 study locations spanning 5 distinct geographic areas — top geographies include Illinois, Alabama, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05868226 about?
NCT05868226 is a clinical study titled "PRE-I-SPY Phase I/Ib Oncology Platform Program". 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 (NCT...
What is the current status of trial NCT05868226?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 124 participants. The study started on 2023-02-15. Estimated completion is 2029-12-30.
What conditions does trial NCT05868226 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, Metastatic Cancer, Triple Negative Breast Cancer, HER2-positive Breast Cancer, HER2-negative Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05868226?
The interventions under investigation include: Tucatinib (DRUG), Zanidatamab (DRUG), ALX148 (DRUG), Fam-Trastuzumab Deruxtecan-Nxki (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05868226?
This trial is sponsored by QuantumLeap Healthcare Collaborative, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05868226 being conducted?
This trial has 7 study locations across Alabama, Florida, Illinois, Minnesota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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