PRE-I-SPY Phase IIb Platform Trial for Testing New Drug Combinations in Metastatic Breast Cancer and Other Solid Tumors

What this Trial Is About

Researchers are investigating treatments for breast cancer and other solid tumors through the PRE-I-SPYI-SPY-P1 platform trial. This open-label, multisite trial focuses on evaluating single drugs or drug combinations in metastatic cancer patients. The goal is to identify promising regimens that can advance quickly into further trials, including the I-SPY 2 SMART Design Trial. The study allows multiple arms, each with specific eligibility criteria, often including dose-finding and dose-expansion phases lasting about 12 to 18 months. The trial tests different drug combinations targeting HER2-positive breast cancer and other related tumors. One combination includes ALX148, a CD47-blocking protein, and Fam-Trastuzumab Deruxtecan-Nxki T-DXd, an antibody-drug conjugate. Another combination studies Zanidatamab, a bispecific HER2 antibody, with Tucatinib, a selective oral drug targeting HER2. These treatments are given to explore their effects on tumor cells and the immune system. Each arm may have dose escalation and expansion parts to find the best dose and evaluate safety and response. Participants will undergo treatment and monitoring over several months, with assessments including laboratory tests, imaging, and safety evaluations. Researchers will track adverse events, dose-limiting toxicities, maximum tolerated dose, response rates, and duration of response. Follow-up will continue for up to a year to observe progression-free survival and clinical benefit. Patients must be willing to comply with study visits and procedures throughout the treatment and observation periods.

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