ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)

Phase 1

Recruiting

• Conditions: Locally Advanced Solid Tumor; Metastatic Solid Tumor
• Interventions: Drug: Cyclophosphamide; Drug: Fludarabine; Drug: ACE2016; Drug: Pembrolizumab

• Registration Number: NCT06415487
• Lead Sponsor: Acepodia Biotech, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-05-10
• Study First Posted: 2024-05-16
• Study Start: 2024-08-22
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-28
• Last Update Posted: 2025-07-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-03-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ACE2016 ONLY: 3 DOSES	Cyclophosphamide	ACE2016 recommended dose, monotherapy. Lymphodepleting regimen followed by recommended dose of ACE2016.
ACE2016 AND PEMBROLIZUMAB: 3 DOSES	ACE2016	ACE2016 recommended dose, in combination with pembrolizumab. Lymphodepleting regimen followed by recommended dose of ACE2016, giving in combination with pembrolizumab.
ACE2016 ONLY: 1 DOSE	ACE2016	ACE2016 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE2016.
ACE2016 ONLY: 3 DOSES	ACE2016	ACE2016 recommended dose, monotherapy. Lymphodepleting regimen followed by recommended dose of ACE2016.
ACE2016 ONLY: 1 DOSE	Cyclophosphamide	ACE2016 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE2016.
ACE2016 ONLY: 3 DOSES	Fludarabine	ACE2016 recommended dose, monotherapy. Lymphodepleting regimen followed by recommended dose of ACE2016.
ACE2016 AND PEMBROLIZUMAB: 3 DOSES	Fludarabine	ACE2016 recommended dose, in combination with pembrolizumab. Lymphodepleting regimen followed by recommended dose of ACE2016, giving in combination with pembrolizumab.
ACE2016 ONLY: 1 DOSE	Fludarabine	ACE2016 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE2016.
ACE2016 AND PEMBROLIZUMAB: 3 DOSES	Cyclophosphamide	ACE2016 recommended dose, in combination with pembrolizumab. Lymphodepleting regimen followed by recommended dose of ACE2016, giving in combination with pembrolizumab.
ACE2016 AND PEMBROLIZUMAB: 3 DOSES	Pembrolizumab	ACE2016 recommended dose, in combination with pembrolizumab. Lymphodepleting regimen followed by recommended dose of ACE2016, giving in combination with pembrolizumab.

Primary Outcome Measures

Name	Time	Method
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	1 year
Change from baseline in clinical laboratory tests results	1 year	Number of subject with change from baseline clinical significant lab findings by cohort (descriptive)
Change from baseline in vital signs results	1 year	Number of subjects with change from baseline clinical significant vital signs findings by cohort (descriptive)
Recommended Dose (RD)	1 year

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	1 year	Duration (time) from first ACE2016 cell infusion to first documentation of disease progression per RECIST v1.1 or death
Duration Of Response (DOR)	1 year	Duration (time) from the first tumor assessment showing response per RECIST v1.1 to the time of disease progression or death.
Persistence of ACE2016 before and after administration	1 year	Half-life of ACE2016
Objective Response Rate (ORR)	1 year	Proportion of subjects assessed as having a complete response (CR) or partial response (PR) according to RECIST v1.1
Measure of anti-ACE2016 antibodies after administration	1 year	Titration of anti-ACE2016 antibodies after administration
Disease Control Rate (DCR)	1 year	Number of subjects with a complete response (CR), partial response (PR) or stable disease (SD) as defined by RECIST v1.1

Trial Locations

Locations (9)

University of California San Diego; 🇺🇸 San Diego, California, United States

SCRI Denver Drug Development Unit; 🇺🇸 Denver, Colorado, United States

Sarah Cannon Research Institute (SCRI) Oncology Partners; 🇺🇸 Nashville, Tennessee, United States

Texas Oncology; 🇺🇸 Dallas, Texas, United States

Taipei Veterans General Hospital; 🇨🇳 Taipei City, Beitou District, Taiwan

Chang Gung Medical Foundation Linkou; 🇨🇳 Taoyuan City, Guishan District, Taiwan

Taipei Medical University-Shuang Ho Hospital; 🇨🇳 New Taipei City, Zhonghe District, Taiwan

Mackay Memorial Hospital Taipei; 🇨🇳 Taipei City, Zhongshan District, Taiwan

Taichung Veteran General Hospital; 🇨🇳 Taichung, Taiwan