Clinical trialPhase 1Completed
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
- Outcome
- Finished, no results posted
- Cell product
- NK and CAR-NK cells
Drug: ACE1702. ACE1702 cellular therapy (anti-HER2 oNK cells) given intravenously
- Target antigen
- HER2
ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
- Cell source
- Allogeneic
ACE1702 (anti-HER2 oNK cells) is an off-the-shelf Natural Killer (NK) cell product that targets human HER2-expressing solid tumors.
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- 24 June 2020
- Ended
- 15 July 2024
- Enrollment
- 12 participants
- Sites
- 3
- Primary outcomes
- Adverse events, including Dose Limiting Toxicities (DLTs) and Serious Adverse Events (SAEs); Phase Ib/II starting dose for ACE1702
- Sponsor type
- Industry
- Results posted
- No
- Last update
- 5 December 2024
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
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Brief summary public domain (ClinicalTrials.gov)
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.
Intervention public domain (ClinicalTrials.gov)
Drug: ACE1702. ACE1702 cellular therapy (anti-HER2 oNK cells) given intravenously
Intervention public domain (ClinicalTrials.gov)
Drug: Cyclophosphamide. Lympho-conditioning agent
Intervention public domain (ClinicalTrials.gov)
Drug: Fludarabine. Lympho-conditioning agent
Arm public domain (ClinicalTrials.gov)
ACE1702 Dose Level 1 (experimental): 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
Arm public domain (ClinicalTrials.gov)
ACE1702 Dose Level 2 (experimental): 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
Arm public domain (ClinicalTrials.gov)
ACE1702 Dose Level 3 (experimental): 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: 3 Planned number of subjects: 3 to 6
Arm public domain (ClinicalTrials.gov)
ACE1702 Dose Level 4 (experimental): 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: 4 Planned number of subjects: 3 to 6
Arm public domain (ClinicalTrials.gov)
ACE1702 Dose Level 5 (experimental): 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: 5 Planned number of subjects: 3 to 6
Arm public domain (ClinicalTrials.gov)
ACE1702 Dose 6 (experimental): 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: 6 Planned number of subjects: 3 to 6
Eligibility public domain (ClinicalTrials.gov)
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