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ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors

NCT04319757 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-12-05

No results posted yet for this study

Summary

ACE1702 (anti-HER2 oNK cells) is an off-the-shelf Natural Killer (NK) cell product that targets human HER2-expressing solid tumors. The ACE1702-001 phase I study aims to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ACE1702 in patients with advanced or metastatic HER2-expressing tumors, and to determine the phase Ib/II starting dose for ACE1702.

Conditions

Interventions

DRUG

ACE1702

ACE1702 cellular therapy (anti-HER2 oNK cells) given intravenously

DRUG

Cyclophosphamide

Lympho-conditioning agent

DRUG

Fludarabine

Lympho-conditioning agent

Sponsors & Collaborators

  • Acepodia Biotech, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Kurman, MD · Acepodia Biotech, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-24
Primary Completion
2024-07-15
Completion
2024-07-15
FDA Drug
Yes

Countries

  • United States
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04319757 on ClinicalTrials.gov