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NCT06415487 · ClinicalTrials.gov registry record · Phase 1

ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)

A Phase 1 study of Metastatic Solid Tumor and Locally Advanced Solid Tumor, sponsored by Acepodia Biotech.

Recruiting
Registry status
Phase 1
Development phase
30
Enrollment target
9
Study locations

NCT06415487 is a Phase 1 study of Metastatic Solid Tumor and Locally Advanced Solid Tumor that is actively recruiting participants, run by Acepodia Biotech. The registered enrollment target is 30 participants, below the 192-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target (84% lower). The trial reports 9 study locations across 9 states.

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The verdict

NCT06415487, a Phase 1 study of Metastatic Solid Tumor and Locally Advanced Solid Tumor, is actively recruiting participants, sponsored by Acepodia Biotech.

RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target
9
Study locations

Study Summary

ACE2016 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment of Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR). The ACE2016-001 study is an open-label, Phase I, first-in-human (FIH) study that aims to evaluate the safety and tolerability, persistency, pharmacodynamics and efficacy of ACE2016 in patients with Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR).

Conditions Studied

Metastatic Solid Tumor Locally Advanced Solid Tumor

Interventions

  • DRUG Pembrolizumab
  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG ACE2016

Study Locations (9)

California

  • University of California San Diego - San Diego

Colorado

  • SCRI Denver Drug Development Unit - Denver

Tennessee

  • Sarah Cannon Research Institute (SCRI) Oncology Partners - Nashville

Texas

  • Texas Oncology - Dallas

Beitou District

  • Taipei Veterans General Hospital - Taipei

Guishan District

  • Chang Gung Medical Foundation Linkou - Taoyuan

Zhonghe District

  • Taipei Medical University-Shuang Ho Hospital - New Taipei City

Zhongshan District

  • Mackay Memorial Hospital Taipei - Taipei

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2024-08-22
Est. Completion 2027-03-27
Phase Phase 1

Sponsor

Acepodia Biotech

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06415487

The ClinicalTrials.gov registry entry for NCT06415487 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 192-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target (84% lower). The listed sponsor is Acepodia Biotech, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Metastatic Solid Tumor appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.

NCT06415487 reports 9 study locations spanning 9 distinct geographic areas - top geographies include California, Colorado, Tennessee.

Frequently Asked Questions

What is clinical trial NCT06415487 about?

NCT06415487 is a clinical study titled "ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)". ACE2016 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment of Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR). The ACE2016-001 study is an open-label, Phase I, fir...

What is the current status of trial NCT06415487?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-08-22. Estimated completion is 2027-03-27.

What conditions does trial NCT06415487 study?

This clinical trial studies the following conditions: Metastatic Solid Tumor, Locally Advanced Solid Tumor.

What interventions are being tested in trial NCT06415487?

The interventions under investigation include: Pembrolizumab (DRUG), Cyclophosphamide (DRUG), Fludarabine (DRUG), ACE2016 (DRUG).

Who is sponsoring clinical trial NCT06415487?

This trial is sponsored by Acepodia Biotech, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06415487 being conducted?

This trial has 9 study locations across California, Colorado, Tennessee, Texas, Beitou District. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.