PRE-ISPY Phase I/II Oncology Platform Program

Study acronym: PRE-ISPY
StatusRecruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years later Dec 30, 2028 → Dec 30, 2030
Primary endpoint reworded 5 of 6 changed
See other at-risk trials from QuantumLeap Healthcare Collaborative

Record History

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  1. Eligibility criteria expanded, about 37 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised at 3 of 10 sites
  2. Primary completion pushed from Dec 30, 2028 to Dec 30, 2030v7 Show 11 more changesShow less
    • Primary endpoint(s) modified
    • Phase changed: Phase 1 → Phase 1/2
    • Enrollment increased: 124 → 280 participants
    • Trial sites expanded: 7 → 10 locations
    • Study completion pushed from Dec 30, 2029 to Dec 30, 2031
    • Interventions modified
    • Trial arms changed: 2 → 3
    • Eligibility criteria expanded, about 117 words
    • Study description shortened, about 12 words
    • Collaborators expanded, about 8 words
    • Study title revised
  3. Enrollment target: 54 to 124v6 Show 5 more changesShow less
    • Primary completion date: Dec 30, 2026 to Dec 30, 2028
    • Start date: Dec 22, 2022 to Feb 15, 2023
    • Study sites: 6 to 7
    • Study completion date: Dec 30, 2027 to Dec 30, 2029
    • Eligibility criteria expanded, about 79 words
  4. Study sites: 5 to 6v5
  5. Enrollment target: 40 to 54v4 Show 5 more changesShow less
    • Study sites: 2 to 5
    • Interventions: ALX148 (Drug), Fam-Trastuzumab Deruxtecan-Nxki (Drug) to ALX148 (Drug), Fam-Trastuzumab Deruxtecan-Nxki (Drug), Tucatinib (Drug), Zanidatamab (Drug)
    • Eligibility criteria shortened, about 16 words
    • Study arms: 1 to 2
    • Study description expanded, about 2 words
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  1. Primary endpoints revised (6)v3
  2. Primary endpoints: 5 to 6v2 Show 4 more changesShow less
    • Study sites: 1 to 2
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description revised
    • Study title expanded, about 2 words
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05868226
Lead Sponsor QuantumLeap Healthcare Collaborative
Collaborators: ALX Oncology Inc., Pfizer, Jazz Pharmaceuticals, TransCode Therapeutics
Conditions
(from sponsor)		 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
Related terms Adenocarcinoma, Breast Neoplasms, Colonic Neoplasms, Colorectal Neoplasms, Neoplasm Metastasis, Neoplasm, Residual, Rectal Neoplasms, Triple Negative Breast Neoplasms
Enrollment 280 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov