NCT05868226

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

PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: QuantumLeap Healthcare Collaborative · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The PRE-I-SPY/I-SPY-P1 study is a platform trial with multiple ongoing drug regimen arms. In most cases, the treatment arm will have a dose-finding group (Part 1) and a dose-expansion group (Part 2). Eligibility criteria will vary according to the experimental regimen. Participant eligibility may vary according to the arm or the part within the study arm, including with respect to diagnosis. Arms could include participants diagnosed with certain solid tumors or specifically with breast cancer. Arms may restrict enrollment to a certain molecular pathway abnormality or histologic diagnosis. The trial allows for various study arm designs, with the goal to complete analysis of a study arm in 12 to 18 months.

Conditions

• HER2-positive Breast Cancer
• Metastatic Cancer
• Metastatic Breast Cancer
• Metastatic
• HER2-positive Metastatic Breast Cancer
• HER2 Mutation-Related Tumors
• HER-2 Protein Overexpression
• HER2-negative Breast Cancer
• Triple Negative Breast Cancer
• HR Positive
• Hormone Receptor-positive Breast Cancer
• Estrogen Receptor Positive Tumor
• Progesterone Receptor-positive Breast Cancer
• Hormone Receptor Negative Breast Carcinoma
• Solid Tumor
• Solid Tumor, Adult
• Solid Carcinoma
• HER2 Low Breast Cancer
• HER2 Low Breast Carcinoma
• ER Positive Breast Cancer
• PR-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	ALX148	CD47 Inhibitor: A fusion protein containing a high affinity engineered D1 domain of human signal regulatory protein alpha (SIRPα) variant 1 (v1) genetically linked to a modified and inactive Fc domain of human immunoglobulin (Ig) G1.
DRUG	Fam-Trastuzumab Deruxtecan-Nxki	Antibody-drug conjugate (ADC): A recombinant humanized anti-human HER2 IgG1 monoclonal antibody, conjugated with linker to a Topoisomerase I inhibitor
DRUG	Zanidatamab	Bispecific HER2 antibody: A humanized, bispecific, immunoglobulin G isotype 1 (IgG1)-like antibody directed against the juxtamembrane extracellular domain (ECD4) and the dimerization domain (ECD2) of human epidermal growth factor receptor 2 (HER2).
DRUG	Tucatinib	Small molecule tyrosine kinase inhibitor (TKI) of HER2 (oral drug).

Timeline

• Start date: 2023-02-15
• Primary completion: 2028-12-30
• Completion: 2029-12-30
• First posted: 2023-05-22
• Last updated: 2025-04-04

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study