ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer

Study acronym: ASPEN-09-03
StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Trial sites expanded: 54 → 60 locations
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 7 of 12 entries
  2. Trial sites expanded: 44 → 54 locations
    • Eligibility criteria expanded, about 22 words
    v9
  3. Trial sites expanded: 32 → 44 locationsv8
  4. Trial sites expanded: 28 → 32 locationsv7
  5. Primary endpoint(s) modifiedv6 Show 10 more changesShow less
    • Phase changed: Phase 1/2 → Phase 2
    • Enrollment increased: 80 → 120 participants
    • Start date: Apr 28, 2025 to Dec 10, 2025
    • Primary completion pushed from Jun 2027 to Dec 2027
    • Trial sites expanded: 11 → 28 locations
    • Study completion pushed from Dec 2027 to Dec 2028
    • Secondary endpoints revised (12)
    • Study description shortened, about 26 words
    • Eligibility criteria shortened, about 4 words
    • Study title expanded, about 1 word
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  1. Study sites: 3 to 11v5
  2. Study sites: 2 to 3v4
  3. Study sites: 1 to 2v3
  4. Enrollment target: 280 to 80v2 Show 6 more changesShow less
    • Primary endpoints: 3 to 1
    • Interventions: Capecitabine (Drug), Cetuximab (Drug), Eribulin (Drug), Evorpacept (ALX148) (Drug), FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)… to Capecitabine (Drug), Eribulin (Drug), Evorpacept (ALX148) (Drug), Gemcitabine (Drug), Paclitaxel (Drug), Trastuzumab (Drug), Vinorelbine…
    • Eligibility criteria shortened, about 222 words
    • Secondary endpoints: 6 to 12
    • Study description expanded, about 29 words
    • Study arms: 3 to 1
  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.
The Substudy Protocol ASPEN-09-03 is a Phase 2, single-arm, multicenter study evaluating the efficacy, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive metastatic breast cancer who have previously received trastuzumab-deruxtecan. This substudy is actively recruiting. ASPEN-09-03 is a substudy under Master Protocol ASPEN-09, and additional substudies are as follows: * Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not open. * Recurrent/metastatic head and neck cancer (HNSCC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not open.
Trial Details
NCT Number NCT07007559
Lead Sponsor ALX Oncology Inc.
Conditions
(from sponsor)		 Breast Cancer, Metastatic
Related terms Breast Neoplasms, Neoplasm Metastasis
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov