NCT05868226View on ClinicalTrials.gov

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

PHASE1RecruitingINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

February 15, 2023

Primary Completion Date

December 30, 2028

Study Completion Date

December 30, 2029

Conditions
HER2-positive Breast CancerMetastatic CancerMetastatic Breast CancerMetastaticHER2-positive Metastatic Breast CancerHER2 Mutation-Related TumorsHER-2 Protein OverexpressionHER2-negative Breast CancerTriple Negative Breast CancerHR PositiveHormone Receptor-positive Breast CancerEstrogen Receptor Positive TumorProgesterone Receptor-positive Breast CancerHormone Receptor Negative Breast CarcinomaSolid TumorSolid Tumor, AdultSolid CarcinomaHER2 Low Breast CancerHER2 Low Breast CarcinomaER Positive Breast CancerPR-positive Breast Cancer
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).

Trial Locations (7)

33612

RECRUITING

Moffitt Cancer Center, Tampa

35233

RECRUITING

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

55455

RECRUITING

University of Minnesota Masonic Cancer Center, Minneapolis

60451

RECRUITING

UChicago Medicine Comprehensive Cancer Center at Silver Cross Hospital, New Lenox

60462

RECRUITING

UChicago Medicine Orland Park, Orland Park

60637

RECRUITING

The University of Chicago Medicine Comprehensive Cancer Center, Chicago

77030

RECRUITING

The University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
lead

QuantumLeap Healthcare Collaborative

OTHER