## Protocol Section
### Identification Module
**NCT ID:** NCT06415487

**Brief Title:** 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)

#### Organization Study ID Info
**ID:** ACE2016-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Acepodia Biotech, Inc.
### Status Module
#### Completion Date
**Date:** 2027-03-25

**Type:** ESTIMATED

#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-12-18

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-30
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Acepodia Biotech, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

### Description Module

**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 Module

**Conditions:**

- Locally Advanced Solid Tumor

- Metastatic Solid Tumor

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: Cyclophosphamide

- Drug: Fludarabine

- Drug: ACE2016

**Label:** ACE2016 ONLY: 1 DOSE

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** ACE2016 recommended dose, monotherapy. Lymphodepleting regimen followed by recommended dose of ACE2016.

**Intervention Names:**

- Drug: Cyclophosphamide

- Drug: Fludarabine

- Drug: ACE2016

**Label:** ACE2016 ONLY: 3 DOSES

**Type:** EXPERIMENTAL

#### Arm Group 3

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

**Intervention Names:**

- Drug: Cyclophosphamide

- Drug: Fludarabine

- Drug: ACE2016

- Drug: Pembrolizumab

**Label:** ACE2016 AND PEMBROLIZUMAB: 3 DOSES

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ACE2016 AND PEMBROLIZUMAB: 3 DOSES

- ACE2016 ONLY: 1 DOSE

- ACE2016 ONLY: 3 DOSES

**Description:** Lymphodepleting agent

**Name:** Cyclophosphamide

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- ACE2016 AND PEMBROLIZUMAB: 3 DOSES

- ACE2016 ONLY: 1 DOSE

- ACE2016 ONLY: 3 DOSES

**Description:** Lymphodepleting agent

**Name:** Fludarabine

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- ACE2016 AND PEMBROLIZUMAB: 3 DOSES

- ACE2016 ONLY: 1 DOSE

- ACE2016 ONLY: 3 DOSES

**Description:** Allogeneic gamma delta T (gdT) cell therapy

**Name:** ACE2016

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- ACE2016 AND PEMBROLIZUMAB: 3 DOSES

**Description:** Immune checkpoint anti-PD-1 antibody

**Name:** Pembrolizumab

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** Change from baseline IL2,6,8,10 IFN TNF, and change in TBNK cell subsets.

**Measure:** Pharmacodynamics of ACE2016

**Time Frame:** 1 year

**Description:** Optional biopsy to examine gdT cell infiltration

**Measure:** gdT infiltration in tumor mass

**Time Frame:** 1 year

#### 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

**Time Frame:** 1 year

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

**Measure:** Change from baseline in clinical laboratory tests results

**Time Frame:** 1 year

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

**Measure:** Change from baseline in vital signs results

**Time Frame:** 1 year

**Measure:** Recommended Dose (RD)

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** Half-life of ACE2016

**Measure:** Persistence of ACE2016 before and after administration

**Time Frame:** 1 year

**Description:** Titration of anti-ACE2016 antibodies after administration

**Measure:** Measure of anti-ACE2016 antibodies after administration

**Time Frame:** 1 year

**Description:** Proportion of subjects assessed as having a complete response (CR) or partial response (PR) according to RECIST v1.1

**Measure:** Objective Response Rate (ORR)

**Time Frame:** 1 year

**Description:** Number of subjects with a complete response (CR), partial response (PR) or stable disease (SD) as defined by RECIST v1.1

**Measure:** Disease Control Rate (DCR)

**Time Frame:** 1 year

**Description:** Duration (time) from the first tumor assessment showing response per RECIST v1.1 to the time of disease progression or death.

**Measure:** Duration Of Response (DOR)

**Time Frame:** 1 year

**Description:** Duration (time) from first ACE2016 cell infusion to first documentation of disease progression per RECIST v1.1 or death

**Measure:** Progression Free Survival (PFS)

**Time Frame:** 1 year

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** clinical@acepodiabio.com

**Name:** Stephanie Chien

**Phone:** +1 415 366 7822

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Denver

**Contacts:**

***Contact 1:***

- **Name:** James Vick

- **Role:** CONTACT

***Contact 2:***

- **Name:** Jason Henry, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** SCRI Denver Drug Development Unit

**State:** Colorado

**Zip:** 80218

**Location 2:**

**City:** Nashville

**Contacts:**

***Contact 1:***

- **Name:** Emily Lay Petcu

- **Role:** CONTACT

***Contact 2:***

- **Name:** Meredith Pelster, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Sarah Cannon Research Institute (SCRI) Oncology Partners

**State:** Tennessee

**Zip:** 37203

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000018906

- Term: Antineoplastic Agents, Alkylating

- ID: D000000477

- Term: Alkylating Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000019653

- Term: Myeloablative Agonists

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000082082

- Term: Immune Checkpoint Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M6727

- Name: Cyclophosphamide

- Relevance: HIGH

- As Found: Cycle

- ID: M283230

- Name: Fludarabine

- Relevance: HIGH

- As Found: Combined

- ID: M225513

- Name: Fludarabine phosphate

- Relevance: LOW

- As Found: Unknown

- ID: M349416

- Name: Pembrolizumab

- Relevance: HIGH

- As Found: Blind

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M11900

- Name: Mitogens

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20942

- Name: Antineoplastic Agents, Alkylating

- Relevance: LOW

- As Found: Unknown

- ID: M3820

- Name: Alkylating Agents

- Relevance: LOW

- As Found: Unknown

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

- ID: M2342

- Name: Immune Checkpoint Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000003520

- Term: Cyclophosphamide

- ID: C000582435

- Term: Pembrolizumab

- ID: C000024352

- Term: Fludarabine

### Misc Info Module

- Version Holder: 2024-05-31
