ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors (NCT04319757) | Clinical Trial Compass
CompletedPhase 1
ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
United States, Taiwan12 participantsStarted 2020-06-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse events, including Dose Limiting Toxicities (DLTs) and Serious Adverse Events (SAEs)
Timeframe: Day 7 through Day 28 / Day 4 through Day 25