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PRE-ISPY Phase I/II Oncology Platform Program

Study acronym: PRE-ISPY
StatusRecruiting
PhasePhase 1/2
Started2023-02-15
View on ClinicalTrials.gov ↗
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.

Amendment history 8 changes detected by DataLookout

2026-09-03
Phase changed: Phase 1 → Phase 1/2
2026-09-03
Primary endpoint(s) modified
WasDuration of Response (DOR), Incidence of Adverse Events related to the treatment, Incidence of Dose Limiting Toxicities (DLTs) at each dose level, Maximum Tolerated Dose (MTD), Overall Response Rate (ORR), Recommended Phase 2 Dose (RP2D)
NowDuration of Response (DOR), For Phase Ib Part 1 drug arms, Recommended Phase 2 Dose (RP2D), For Phase Ib Part 1 study design: Incidence of Dose Limiting Toxicities (DLTs) at each dose level, For select drug arms, Maximum Tolerated Dose (MTD), Incidence of Adverse Events related to the treatment, Overall Response Rate (ORR)
2026-09-03
Enrollment increased: 124 → 280 participants
2026-09-03
Trial arms changed: 2 → 3
2026-09-03
Trial sites expanded: 7 → 10 locations
2026-09-03
Primary completion pushed: 2028-12-30 → 2030-12-30
2026-09-03
Completion pushed: 2029-12-30 → 2031-12-30
2026-09-03
Interventions modified
Trial Details
NCT Number NCT05868226
Lead Sponsor QuantumLeap Healthcare Collaborative
Collaborators: ALX Oncology Inc., Pfizer, Jazz Pharmaceuticals, TransCode Therapeutics
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 +24 more
Enrollment 280 participants
Start Date 2023-02-15
Primary Completion 2030-12-30 (estimated)
Study Completion 2031-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-02