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

NCT05868226 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2025-04-04

No results posted yet for this 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

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).

Sponsors & Collaborators

  • QuantumLeap Healthcare Collaborative

    lead OTHER

Principal Investigators

  • Paula R Pohlmann, MD, MSc, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2028-12-30
Completion
2029-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05868226 on ClinicalTrials.gov