Clinical trialNCT05868226RecruitingPhase 1Interventional

PRE-I-SPY Phase I/Ib Oncology Platform Program

SponsorQuantumLeap Healthcare CollaborativeEnrollment124ER Positive Breast CancerEstrogen Receptor Positive TumorHER-2 Protein OverexpressionHER2 Low Breast CancerHER2 Low Breast CarcinomaHER2 Mutation-Related Tumors+15 more conditions

View the registry record on ClinicalTrials.gov

Summary

The registered summary isn't in our current data snapshot. Read it on the ClinicalTrials.gov record ↗. Why? →

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Paula R Pohlmann, MD, MSc, PhD
M.D. Anderson Cancer Center
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

the University of Alabama at Birmingham O'Neal Comprehensive Cancer Center
Birmingham, Alabama, United States
Erica Stringer-Reasor, MDGabrielle Rocque, MDKatia Khoury, MDNusrat Jahan, MD
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Hyo Han, MD
Recruiting
the University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States
Nan Chen, MDRita Nanda, MD
Recruiting
Uchicago Medicine Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, United States
Nan Chen, MD
Recruiting
Uchicago Medicine Orland Park
Orland Park, Illinois, United States
Nan Chen, MD
Recruiting
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
David Potter, MD, PhDDoug Yee, MD
Recruiting
the University of Texas Md Anderson Cancer Center
Houston, Texas, United States
Bora Lim, MDDebasish Tripathy, MDEcaterina E Dumbrava, MDFunda Meric-Bernstam, MDJason A Mouabbi, MDPaula R Pohlmann, MD, MSc, PhD
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ALX148Trastuzumab →Tucatinib →Zanidatamab →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 15 Feb 2023
Primary completion: 30 Dec 2028
Completion: 30 Dec 2029
Last update posted: 4 Apr 2025
Registered enrollment: 124
Registry id: NCT05868226

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 12 Jul 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.