ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcepodia Biotech, Inc.
About this trial
ACE2016 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment of Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR).
The ACE2016-001 study is an open-label, Phase I, first-in-human (FIH) study that aims to evaluate the safety and tolerability, persistency, pharmacodynamics and efficacy of ACE2016 in patients with Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR).
Eligibility criteria
Qualifiers
Locally advanced unresectable or metastatic solid tumors that have failed at least two lines of therapy (one of which must be targeted therapy)
At least one measurable lesion as defined by RECIST v1.1 criteria
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Adequate hematologic and renal, hepatic and cardiac function
Disqualifiers
Prior treatment with a genetically modified cell therapy product targeting EGFR
History of allogeneic transplantation
Subjects with active CNS metastases
History or presence of clinically relevant Central Nervous System (CNS) disorder (e.g. epilepsy)
Trial design
Treatments tested in this trial
- Cyclophosphamide
- Fludarabine
- ACE2016
- Pembrolizumab
Treatment groups
30 Participants
are divided into 3 treatment groupsLocations
9Taiwan
Taipei Veterans General Hospital112, TaipeiBeitou District, Taiwan
Chang Gung Medical Foundation Linkou3333, Taoyuan CityGuishan District, Taiwan
Taipei Medical University-Shuang Ho Hospital235, New Taipei CityZhonghe District, Taiwan
Mackay Memorial Hospital Taipei104, TaipeiZhongshan District, Taiwan
Sponsors and collaborators
Acepodia Biotech, Inc.
Lead sponsor
Source ClinicalTrials.gov