PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial
QuantumLeap Healthcare Collaborative
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.
Description
The PRE-I-SPY/I-SPY-P1 study is a platform trial with multiple ongoing drug regimen arms. In most cases, the treatment arm will have a dose-finding group (Part 1) and a dose-expansion group (Part 2). Eligibility criteria will vary according to the experimental regimen. Participant eligibility may vary according to the arm or the part within the study arm, including with respect to diagnosis. Arms could include participants diagnosed with certain solid tumors or specifically with breast cancer. Arms may restrict enrollment to a certain molecular pathway abnormality or histologic diagnosis. The…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
General Inclusion Criteria (GIC): * GIC1: The participant must have ability to understand and willingness to provide signed written informed consent prior to any study related assessments and procedures and for collection of archival FFPE blocks (freshly cut 14 unstained tumor slides would be acceptable). * GIC2: Age ≥ 18 years at the time of signing the informed consent * GIC3: Gender: Male or female (premenopausal and postmenopausal) * GIC4: ECOG performance status Grade 0-2 * GIC5: Estimated life expectancy \> 12 weeks at the start of investigational medicinal product (IMP) treatment. * GI…
Interventions
- DrugALX148
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.
- DrugFam-Trastuzumab Deruxtecan-Nxki
Antibody-drug conjugate (ADC): A recombinant humanized anti-human HER2 IgG1 monoclonal antibody, conjugated with linker to a Topoisomerase I inhibitor
- DrugZanidatamab
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).
- DrugTucatinib
Small molecule tyrosine kinase inhibitor (TKI) of HER2 (oral drug).
Locations (7)
- The University of Alabama at Birmingham O'Neal Comprehensive Cancer CenterBirmingham, Alabama
- Moffitt Cancer CenterTampa, Florida
- The University of Chicago Medicine Comprehensive Cancer CenterChicago, Illinois
- UChicago Medicine Comprehensive Cancer Center at Silver Cross HospitalNew Lenox, Illinois
- UChicago Medicine Orland ParkOrland Park, Illinois
- University of Minnesota Masonic Cancer CenterMinneapolis, Minnesota