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RECRUITING
NCT05868226
PHASE1

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

Sponsor: QuantumLeap Healthcare Collaborative

View on ClinicalTrials.gov

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.

Official title: PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2023-02-15

Completion Date

2029-12-30

Last Updated

2025-04-04

Healthy Volunteers

No

Interventions

DRUG

ALX148

CD47 Inhibitor: A fusion protein containing a high affinity engineered D1 domain of human signal regulatory protein alpha (SIRPα) variant 1 (v1) genetically linked to a modified and inactive Fc domain of human immunoglobulin (Ig) G1.

DRUG

Fam-Trastuzumab Deruxtecan-Nxki

Antibody-drug conjugate (ADC): A recombinant humanized anti-human HER2 IgG1 monoclonal antibody, conjugated with linker to a Topoisomerase I inhibitor

DRUG

Zanidatamab

Bispecific HER2 antibody: A humanized, bispecific, immunoglobulin G isotype 1 (IgG1)-like antibody directed against the juxtamembrane extracellular domain (ECD4) and the dimerization domain (ECD2) of human epidermal growth factor receptor 2 (HER2).

DRUG

Tucatinib

Small molecule tyrosine kinase inhibitor (TKI) of HER2 (oral drug).

Locations (7)

The University of Alabama at Birmingham O'Neal Comprehensive Cancer Center

Birmingham, Alabama, United States

Moffitt Cancer Center

Tampa, Florida, United States

The University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

UChicago Medicine Comprehensive Cancer Center at Silver Cross Hospital

New Lenox, Illinois, United States

UChicago Medicine Orland Park

Orland Park, Illinois, United States

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States