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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Cyclophosphamide
DrugLymphodepleting agent
Fludarabine
DrugLymphodepleting agent
ACE2016
DrugAllogeneic gamma delta T (gdT) cell therapy
Pembrolizumab
DrugImmune checkpoint anti-PD-1 antibody
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: ACE2016 ONLY: 1 DOSEExperimental treatment 3 interventions
Group B: ACE2016 ONLY: 3 DOSESExperimental treatment 3 interventions
Group C: ACE2016 AND PEMBROLIZUMAB: 3 DOSESExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Incidence of DLTs, AESIs, Grade 3 or higher TEAEs, TEAEs considered related to ACE2016, TEAEs resulting in death, SAEs, related SAEs, and TEAEs leading to treatment discontinuation will be summarized by cohort
Time frame
1 year2
Change from baseline in clinical laboratory tests results
Number of subject with change from baseline clinical significant lab findings by cohort (descriptive)
Time frame
1 year3
Change from baseline in vital signs results
Number of subjects with change from baseline clinical significant vital signs findings by cohort (descriptive)
Time frame
1 year4
Recommended Dose (RD)
Time frame
1 yearSecondary outcomes
1
Persistence of ACE2016 before and after administration
Half-life of ACE2016
Time frame
1 year2
Measure of anti-ACE2016 antibodies after administration
Titration of anti-ACE2016 antibodies after administration
Time frame
1 year3
Objective Response Rate (ORR)
Proportion of subjects assessed as having a complete response (CR) or partial response (PR) according to RECIST v1.1
Time frame
1 year4
Disease Control Rate (DCR)
Number of subjects with a complete response (CR), partial response (PR) or stable disease (SD) as defined by RECIST v1.1
Time frame
1 yearOther outcomes
1
Pharmacodynamics of ACE2016
Change from baseline IL2,6,8,10 IFN TNF, and change in TBNK cell subsets.
Time frame
1 year2
gdT infiltration in tumor mass
Optional biopsy to examine gdT cell infiltration
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov