NCT04319757CompletedPhase 1
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 · Last updated 5 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 18 Mar 2020
- Start date
- 24 Jun 2020
- Primary completion date
- 15 Jul 2024
- Lead sponsor
- Acepodia Biotech, Inc.
- Diseases
- Head and neck cancer, Bladder cancer, Endometrial cancer, Lung cancer, Pancreatic cancer, Metastatic breast cancer, Colorectal cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT04319757
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 12
- From 24 Jun 2020 to the primary completion date, 15 Jul 2024
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Multiple primary malignancies
- Clinically significant cardiovascular disease such as New York Heart Association (NYHA) cardiac disease (class III or greater)
- 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
Other
- Untreated central nervous system (CNS) metastases
- Pregnant or lactating female
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Taipei Veteran General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Northwestern Univeristy Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.