Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Gastric Cancer | HER2-Positive Gastric Adenocarcinoma | ALIAS | 0.90 |
| HER2-positive Metastatic Breast Cancer | — | UNRESOLVED | — |
| Locally Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ACE1702 | Drug | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- ACE1702 Dose Level 1
- description
- Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 immunohistochemistry (IHC) 2+ or above. Dose Level: 1 Planned number of subjects: 1 to 6
- interventionNames
- Drug: ACE1702
- Drug: Cyclophosphamide
- Drug: Fludarabine
- type
- EXPERIMENTAL
- label
- ACE1702 Dose Level 2
- description
- Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: 2 Planned number of subjects: 1 to 6
- interventionNames
- Drug: ACE1702
- Drug: Cyclophosphamide
- Drug: Fludarabine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * Subjects must be ≥ 18 years of age ( ≥ 20 years of age for Taiwan site) * Subject with advanced or metastatic solid tumors that is not amenable to surgical resection and is not eligible or has refused other approved therapeutic options that have demonstrated clinical benefit. * Histologically confirmed HER2 expression. * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 * Measurable or non-measurable evaluable disease according to RECIST 1.1 * Adequate hematologic and end-organ function at baseline * Oxygen saturation via pulse oxygenation ≥ 90% at rest on room air Exclusion Criteria: * Untreated central nervous system (CNS) metastases * Multiple primary malignancies * Clinically significant cardiovascular disease such as New York Heart Association (NYHA) cardiac disease (class III or greater) * Pregnant or lactating female * Serious, uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive study treatment * History of autoimmune or immune mediated symptomatic disease * Any anti-cancer chemotherapy or targeted small molecule therapy, or experimental therapy/device within 4 weeks or 5 half-lives of the drug prior to planned start of the study
References
Publications (0)
Data not yet available