Trials / Completed
CompletedNCT04319757
ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
A Phase I, Open Label, Dose Escalation Study of ACE1702 Cell Immunotherapy in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Acepodia Biotech, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
- Locally Advanced Solid Tumor
- Metastatic Cancer
- Solid Tumor
- HER2-positive Gastric Cancer
- HER2-positive Metastatic Breast Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ACE1702 | ACE1702 cellular therapy (anti-HER2 oNK cells) given intravenously |
| DRUG | Cyclophosphamide | Lympho-conditioning agent |
| DRUG | Fludarabine | Lympho-conditioning agent |
Timeline
- Start date
- 2020-06-24
- Primary completion
- 2024-07-15
- Completion
- 2024-07-15
- First posted
- 2020-03-24
- Last updated
- 2024-12-05
Locations
3 sites across 2 countries: United States, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04319757. Inclusion in this directory is not an endorsement.