RecruitingPhase 1NCT05868226

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

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

Sponsor

QuantumLeap Healthcare Collaborative

Enrollment

124 participants

Start Date

Feb 15, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Breast Cancer HER2-negative Breast Cancer Metastatic Cancer HER2-positive Breast Cancer HER2-positive Metastatic Breast Cancer Metastatic HER2 Mutation-Related Tumors HER-2 Protein Overexpression

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase cancer research platform studying new drug combinations in people with advanced solid tumours. It is designed to test whether new treatments are safe and to find the right doses before larger trials begin. **You may be eligible if...** - You are 18 or older - You have an advanced or metastatic solid tumour - Your overall health is reasonably good (able to carry out light activities) - You are willing and able to give informed consent **You may NOT be eligible if...** - Your performance status is too low (too unwell to manage daily activities) - You have certain blood count or organ function abnormalities - You do not meet the specific criteria for the drug being tested in your sub-study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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).