Phase 1: Pre-ISPY - Quantum Leap

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What is the Phase I: Pre-ISPY Trial?

I-SPY Phase 1b is an open-label 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 I-SPY 2 Trial (2.2 arms) and/or other oncology-based trials in a timely manner.

The Trial

The primary objectives of this platform trial are to determine the safety and tolerability of new agents/regimes in patients with certain advanced solid tumors and breast cancer while obtaining preliminary efficacy data of the new agents/regimes. The study was developed to help investigators and industry partners meet the safety qualifications necessary for participation in I-SPY 2.2 TRIAL and/or other phase II/III studies.

The study consists of three arms:

Arm 1: ALX148 and T-DXd (Enhertu (r))
Zanidatamab and Tucatinib
Vidutolimod and Cemiplimab

ALX148 and T-DXd
(Enhertu (r)):

The open label PRE-I-SPY Phase Ib platform trial of ALX148 (Evorpacept) and fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu®) is now open (June 2023) at the Masonic Cancer, University of Minnesota. The combination of T-DXd and ALX148 aims to study the anti-tumoral effects of Enhertu® and the CD47 (don’t eat me signal)-blocking agent ALX148. The rationale for this combination is that ALX148 is hypothesized to facilitate antibody-dependent cellular phagocytosis of HER2 low (1 or 2+) or high (3+) expressing breast cancer binding T-DXd while cytotoxicity of T-DXd is expected to promote immune mediated antitumor activity. The trial will have a dose-finding group (Part 1) and a dose-expansion group (Part 2). Eligibility criteria will vary according to the status of enrollment to the trial.