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RECRUITING
NCT05868226
PHASE1/PHASE2

PRE-ISPY Phase I/II Oncology Platform Program

Sponsor: QuantumLeap Healthcare Collaborative

View on ClinicalTrials.gov

Summary

PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced, incurable, or metastatic solid tumors and/or oligometastatic malignancy and/or a high risk of recurrence following prior treatment with curative intent. The overall goal is moving promising drug regimens into a larger phase II (or III) trial and in general could feed the neoadjuvant breast I-SPY 2 Trial (NCT01042379) and/or other oncology solid tumor trial in a timely manner.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2023-02-15

Completion Date

2031-12-30

Last Updated

2026-09-30

Healthy Volunteers

No

Interventions

DRUG

ALX148

Starting dose Dose Level 1 30mg/kg IV Q3W; Dose Level Minus 1 20 mg/kg IV Q3W (if needed); Dose Level 2 45 mg/kg IV Q3W;

DRUG

Fam-Trastuzumab Deruxtecan-Nxki

5.4 mg/kg IV Q3W; allowed to dose reduce after DLT observation period

DRUG

Zanidatamab

20 mg/kg IV Q2W on Day 1 and Day 15 of each 28 day cycle

DRUG

Tucatinib

Dose Level 1: 300 mg PO BID daily; Dose Leve Minus 1: 250 mg PO BID daily

DRUG

TTX-MC138

4.8 mg/kg Q4W IV on Day 1 for up to 12 cycles as interception therapy

Locations (10)

The University of Alabama at Birmingham O'Neal Comprehensive Cancer Center

Birmingham, Alabama, United States

Mayo Clinic Comprehensive Cancer Center

Phoenix, Arizona, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Moffitt Cancer Center

Tampa, Florida, United States

The University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

UChicago Medicine Comprehensive Cancer Center at Silver Cross Hospital

New Lenox, Illinois, United States

UChicago Medicine Orland Park

Orland Park, Illinois, United States

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, United States

Mayo Clinic Comprehensive Cancer Center

Rochester, Minnesota, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States