Pharma Focus Asia

ALX Oncology and Quantum Leap Healthcare Collaborative™ Announce First Patient Dosed in the I-SPY-P1 TRIAL

Monday, March 13, 2023

ALX Oncology Holdings and Quantum Leap Healthcare Collaborative (“Quantum Leap”) announced that the first patient has been dosed in the I-SPY-P1-TRIAL for the treatment of patients with unresectable or metastatic HER2-positive and HER2-low breast cancer. This Phase 1 (open-label), multi-centre study arm will investigate evorpacept, a CD47 blocker, in combination with ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody-drug conjugate (“ADC”), to determine the safety, tolerability and efficacy of this drug combination.

The I-SPY Phase 1 trial is the newest member of the I-SPY master protocols. It is designed to rapidly test the safety and identify the optimal dose of promising combinations of novel therapeutics that are particularly effective in the early-stage high-risk breast cancer, but where additional safety or dose finding is necessary. The phase 1 trial is designed to accelerate the pace of advancing safe, effective, and less toxic therapies to the early-stage treatments where lives can be saved. I-SPY 2.2 TRIAL is uniquely poised to test a treatment's ability to produce a complete response when standard chemotherapy can be avoided.

The combination of a novel CD47 blocker with a HER2-directed ADC represents a promising strategy for patients with advanced breast cancer who develop resistance to other therapies and are in urgent need of new treatment options. The I-SPY Phase 1 programme is designed to rapidly assess safety of novel therapy combinations that will help advanced cancer patients, but also rapidly qualify them to be tested in the high-risk early stage setting in the I-SPY 2.2 TRIAL, where complete responses result in curing patients.

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