Clinical trial NCT06415487: ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)
Official title: A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE2016, an Allogeneic Anti-EGFR Conjugated Gamma Delta T Cell (gdT) Therapy in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Locally Advanced Solid Tumor
Metastatic Solid Tumor
Lead sponsor: Acepodia Biotech, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* 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
* Oxygen saturation via pulse oximeter ≥92% at rest on room air

Exclusion Criteria:

* 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)
* Clinically significant active infection
* Human Immunodeficiency Virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
* History of malignancies with the exception of certain treated malignancies with no evidence of disease.
* Primary immunodeficiency disorder
* Pregnant or lactating female
* Any medical, psychological, familial, or sociological conditions that, in the opinion of the Investigator or Sponsor Medical Monitor, would impair the ability of the subject to receive study treatment or comply with study requirements, including understanding and rendering of informed consent

Primary outcomes:
measure: 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
timeFrame: 1 year
measure: Change from baseline in clinical laboratory tests results
timeFrame: 1 year
measure: Change from baseline in vital signs results
timeFrame: 1 year
measure: Recommended Dose (RD)
timeFrame: 1 year
Secondary outcomes:
measure: Persistence of ACE2016 before and after administration
timeFrame: 1 year
measure: Measure of anti-ACE2016 antibodies after administration
timeFrame: 1 year
measure: Objective Response Rate (ORR)
timeFrame: 1 year
measure: Disease Control Rate (DCR)
timeFrame: 1 year
measure: Duration Of Response (DOR)
timeFrame: 1 year
measure: Progression Free Survival (PFS)
timeFrame: 1 year
Other outcomes:
measure: Pharmacodynamics of ACE2016
timeFrame: 1 year
measure: gdT infiltration in tumor mass
timeFrame: 1 year
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Denver
country: United States
facility: SCRI Denver Drug Development Unit
state: Colorado
city: Nashville
country: United States
facility: Sarah Cannon Research Institute (SCRI) Oncology Partners
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology
state: Texas
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
state: Beitou District
city: Taoyuan City
country: Taiwan
facility: Chang Gung Medical Foundation Linkou
state: Guishan District
city: New Taipei City
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital
state: Zhonghe District
city: Taipei City
country: Taiwan
facility: Mackay Memorial Hospital Taipei
state: Zhongshan District
city: Taichung
country: Taiwan
facility: Taichung Veteran General Hospital
Study officials:
References: