drugset / Trial / NCT05868226

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

NCT05868226

Phase 1 Recruiting 124 enrolled QuantumLeap Healthcare Collaborative
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-02-15
Primary completion
2028-12-30
Completion
2029-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Evorpacept Protein / enzyme biologic
Subject Trastuzumab deruxtecan Monoclonal antibody
Subject Tucatinib Small molecule Oral
Subject Zanidatamab Monoclonal antibody