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

NCT06415487 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ACE2016-001
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 9

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).

Conditions

Locally Advanced Solid Tumor; Metastatic Solid Tumor

Outcome Measures

Primary Outcomes (4)

• 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

  Number of subject with change from baseline clinical significant lab findings by cohort (descriptive)

  1 year

• Change from baseline in vital signs results

  Number of subjects with change from baseline clinical significant vital signs findings by cohort (descriptive)

  1 year

• Recommended Dose (RD)

  1 year

Secondary Outcomes (6)

• Persistence of ACE2016 before and after administration

  1 year

• Measure of anti-ACE2016 antibodies after administration

  1 year

• Objective Response Rate (ORR)

  1 year

• Disease Control Rate (DCR)

  1 year

• Duration Of Response (DOR)

  1 year

Other Outcomes (2)

• Pharmacodynamics of ACE2016

  1 year

• gdT infiltration in tumor mass

  1 year

Study Arms (3)

ACE2016 ONLY: 1 DOSE

EXPERIMENTAL

ACE2016 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE2016.

Drug: Cyclophosphamide; Drug: Fludarabine; Drug: ACE2016

ACE2016 ONLY: 3 DOSES

EXPERIMENTAL

ACE2016 recommended dose, monotherapy. Lymphodepleting regimen followed by recommended dose of ACE2016.

Drug: Cyclophosphamide; Drug: Fludarabine; Drug: ACE2016

ACE2016 AND PEMBROLIZUMAB: 3 DOSES

EXPERIMENTAL

ACE2016 recommended dose, in combination with pembrolizumab. Lymphodepleting regimen followed by recommended dose of ACE2016, giving in combination with pembrolizumab.

Drug: Cyclophosphamide; Drug: Fludarabine; Drug: ACE2016; Drug: Pembrolizumab

Interventions

Cyclophosphamide DRUG

Lymphodepleting agent

ACE2016 AND PEMBROLIZUMAB: 3 DOSES; ACE2016 ONLY: 1 DOSE; ACE2016 ONLY: 3 DOSES

Fludarabine DRUG

Lymphodepleting agent

ACE2016 AND PEMBROLIZUMAB: 3 DOSES; ACE2016 ONLY: 1 DOSE; ACE2016 ONLY: 3 DOSES

ACE2016 DRUG

Allogeneic gamma delta T (gdT) cell therapy

ACE2016 AND PEMBROLIZUMAB: 3 DOSES; ACE2016 ONLY: 1 DOSE; ACE2016 ONLY: 3 DOSES

Pembrolizumab DRUG

Immune checkpoint anti-PD-1 antibody

ACE2016 AND PEMBROLIZUMAB: 3 DOSES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acepodia Biotech, Inc.: lead

Study Sites (9)

University of California San Diego

San Diego, California, 92093, United States

RECRUITING

SCRI Denver Drug Development Unit

Denver, Colorado, 80218, United States

RECRUITING

Sarah Cannon Research Institute (SCRI) Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology

Dallas, Texas, 75246, United States

RECRUITING

Taipei Veterans General Hospital

Taipei, Beitou District, 112, Taiwan

NOT YET RECRUITING

Chang Gung Medical Foundation Linkou

Taoyuan, Guishan District, 3333, Taiwan

NOT YET RECRUITING

Taipei Medical University-Shuang Ho Hospital

New Taipei City, Zhonghe District, 235, Taiwan

NOT YET RECRUITING

Mackay Memorial Hospital Taipei

Taipei, Zhongshan District, 104, Taiwan

NOT YET RECRUITING

Taichung Veteran General Hospital

Taichung, 40705, Taiwan

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Cyclophosphamide; fludarabine; pembrolizumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Stephanie Chien

CONTACT

+1 415 366 7822; clinical@acepodiabio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 16, 2024
• Study Start: August 22, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 27, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (5); US (4)