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.

Zanidatamab and Tucatinib

Launching soon.

Vidutolimod and Cemiplimab

Launching soon.

For more information contact:

Investigators & Clinicians email Smita Asare at smita.asare@quantumleaphealth.org

Interested Patients please visit clinicaltrials.gov

Download a List of
Pre-ISPY Trial Sites

View a full listing of sites organized by state.

Pre-ISPY Trial Sites

Adobe PDF (554kb)

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