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

Acepodia Biotech

Status and phase: Enrolling; Phase 1

Conditions: Locally Advanced Solid Tumor; Metastatic Solid Tumor

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06415487

ACE2016-001

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

ACE2016 ONLY: 1 DOSE

Experimental group

Description:

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

Treatment:

Drug: Cyclophosphamide

Drug: ACE2016

Drug: Fludarabine

ACE2016 ONLY: 3 DOSES

Experimental group

Description:

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

Treatment:

Drug: Cyclophosphamide

Drug: ACE2016

Drug: Fludarabine

ACE2016 AND PEMBROLIZUMAB: 3 DOSES

Experimental group

Description:

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

Treatment:

Drug: Cyclophosphamide

Drug: Pembrolizumab

Drug: ACE2016

Drug: Fludarabine