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

Metastatic Solid Tumor Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06415487
• Other study ID #: ACE2016-001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 31, 2024
• Est. completion date: March 25, 2027

Study information

• Verified date: May 2024
• Source: Acepodia Biotech, Inc.
• Contact: Stephanie Chien
• Phone: +1 415 366 7822
• Email: clinical[@]acepodiabio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 25, 2027
• Est. primary completion date: December 18, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced Solid Tumor
• Metastatic Solid Tumor
• Neoplasms

Intervention

Drug:
• Cyclophosphamide
Lymphodepleting agent
• Fludarabine
Lymphodepleting agent
• ACE2016
Allogeneic gamma delta T (gdT) cell therapy
• Pembrolizumab
Immune checkpoint anti-PD-1 antibody

Locations

Country	Name	City	State
United States	SCRI Denver Drug Development Unit	Denver	Colorado
United States	Sarah Cannon Research Institute (SCRI) Oncology Partners	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Acepodia Biotech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacodynamics of ACE2016	Change from baseline IL2,6,8,10 IFN TNF, and change in TBNK cell subsets.	1 year
Other	gdT infiltration in tumor mass	Optional biopsy to examine gdT cell infiltration	1 year
Primary	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
Primary	Change from baseline in clinical laboratory tests results	Number of subject with change from baseline clinical significant lab findings by cohort (descriptive)	1 year
Primary	Change from baseline in vital signs results	Number of subjects with change from baseline clinical significant vital signs findings by cohort (descriptive)	1 year
Primary	Recommended Dose (RD)		1 year
Secondary	Persistence of ACE2016 before and after administration	Half-life of ACE2016	1 year
Secondary	Measure of anti-ACE2016 antibodies after administration	Titration of anti-ACE2016 antibodies after administration	1 year
Secondary	Objective Response Rate (ORR)	Proportion of subjects assessed as having a complete response (CR) or partial response (PR) according to RECIST v1.1	1 year
Secondary	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	1 year
Secondary	Duration Of Response (DOR)	Duration (time) from the first tumor assessment showing response per RECIST v1.1 to the time of disease progression or death.	1 year
Secondary	Progression Free Survival (PFS)	Duration (time) from first ACE2016 cell infusion to first documentation of disease progression per RECIST v1.1 or death	1 year