ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors

NCT04319757 | Completed Phase 1 FDA Drug

• 1 other identifier: ACE1702-001
• Study Type: interventional
• Target: 12
• Locations: 2 countries
• Sites: 3

Brief Summary

ACE1702 (anti-HER2 oNK cells) is an off-the-shelf Natural Killer (NK) cell product that targets human HER2-expressing solid tumors. The ACE1702-001 phase I study aims to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ACE1702 in patients with advanced or metastatic HER2-expressing tumors, and to determine the phase Ib/II starting dose for ACE1702.

Conditions

Locally Advanced Solid Tumor; Metastatic Cancer; Solid Tumor; HER2-positive Gastric Cancer; HER2-positive Metastatic Breast Cancer

Keywords

NK Cell Therapy; Cellular Therapy; Breast Cancer; Gastric Cancer; Ovarian Cancer; Endometrial Cancer; Metastatic Cancer; Colorectal Cancer; Head and Neck Cancer; Pancreatic Cancer; Bladder Cancer; Non-small-cell Lung Carcinoma

Outcome Measures

Primary Outcomes (2)

• Adverse events, including Dose Limiting Toxicities (DLTs) and Serious Adverse Events (SAEs)

  Number of subjects experiencing adverse events, and the frequency and severity of adverse events. Endpoint for determining the Maximum Tolerated Dose (MTD). If MTD is not identified, the highest dose administered becomes the Maximum Administered Dose (MAD).

  Day 7 through Day 28 / Day 4 through Day 25

• Phase Ib/II starting dose for ACE1702

  The recommended phase Ib/II starting dose based on MTD. If MTD is not reached, then the recommended phase Ib/II dose will be determined based on the MAD, safety data, and pharmacodynamics data.

  Through study completion, up to 1 year

Secondary Outcomes (2)

• Quantify NK cell persistence after administering ACE1702

  Day 21

• Evaluate immune function after administering ACE1702

  Day 21

Other Outcomes (2)

• Tumor response using Response Evaluation Criteria In Solid Tumors Assessment (RECIST) version 1.1

  Day 35 (+7 day window) of each 6 week cycle, up to 24 months

• Shift in serum tumor marker values (CA-125, CA 19-9, and CEA levels, in applicable tumor types)

  Day 35 (+7 day window) of each 6 week cycle, up to 24 months

Study Arms (6)

ACE1702 Dose Level 1

EXPERIMENTAL

Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 immunohistochemistry (IHC) 2+ or above. Dose Level: 1 Planned number of subjects: 1 to 6

Drug: ACE1702; Drug: Cyclophosphamide; Drug: Fludarabine

ACE1702 Dose Level 2

EXPERIMENTAL

Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: 2 Planned number of subjects: 1 to 6

Drug: ACE1702; Drug: Cyclophosphamide; Drug: Fludarabine

ACE1702 Dose Level 3

EXPERIMENTAL

Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: 3 Planned number of subjects: 3 to 6

Drug: ACE1702; Drug: Cyclophosphamide; Drug: Fludarabine

ACE1702 Dose Level 4

EXPERIMENTAL

Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: 4 Planned number of subjects: 3 to 6

Drug: ACE1702; Drug: Cyclophosphamide; Drug: Fludarabine

ACE1702 Dose Level 5

EXPERIMENTAL

Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: 5 Planned number of subjects: 3 to 6

Drug: ACE1702; Drug: Cyclophosphamide; Drug: Fludarabine

ACE1702 Dose 6

EXPERIMENTAL

Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: 6 Planned number of subjects: 3 to 6

Drug: ACE1702; Drug: Cyclophosphamide; Drug: Fludarabine

Interventions

ACE1702 DRUG

ACE1702 cellular therapy (anti-HER2 oNK cells) given intravenously

ACE1702 Dose 6; ACE1702 Dose Level 1; ACE1702 Dose Level 2; ACE1702 Dose Level 3; ACE1702 Dose Level 4; ACE1702 Dose Level 5

Cyclophosphamide DRUG

Lympho-conditioning agent

ACE1702 Dose 6; ACE1702 Dose Level 1; ACE1702 Dose Level 2; ACE1702 Dose Level 3; ACE1702 Dose Level 4; ACE1702 Dose Level 5

Fludarabine DRUG

Lympho-conditioning agent

ACE1702 Dose 6; ACE1702 Dose Level 1; ACE1702 Dose Level 2; ACE1702 Dose Level 3; ACE1702 Dose Level 4; ACE1702 Dose Level 5

Eligibility Criteria

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

You may qualify if:

• Signed informed consent
• Subjects must be ≥ 18 years of age ( ≥ 20 years of age for Taiwan site)
• Subject with advanced or metastatic solid tumors that is not amenable to surgical resection and is not eligible or has refused other approved therapeutic options that have demonstrated clinical benefit.
• Histologically confirmed HER2 expression.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
• Measurable or non-measurable evaluable disease according to RECIST 1.1
• Adequate hematologic and end-organ function at baseline
• Oxygen saturation via pulse oxygenation ≥ 90% at rest on room air

You may not qualify if:

• Untreated central nervous system (CNS) metastases
• Multiple primary malignancies
• Clinically significant cardiovascular disease such as New York Heart Association (NYHA) cardiac disease (class III or greater)
• Pregnant or lactating female
• Serious, uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive study treatment
• History of autoimmune or immune mediated symptomatic disease
• Any anti-cancer chemotherapy or targeted small molecule therapy, or experimental therapy/device within 4 weeks or 5 half-lives of the drug prior to planned start of the study

Sponsors & Collaborators

• Acepodia Biotech, Inc.: lead

Study Sites (3)

Northwestern Univeristy

Chicago, Illinois, 60611, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Taipei Veteran General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Breast Neoplasms; Stomach Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Colorectal Neoplasms; Head and Neck Neoplasms; Pancreatic Neoplasms; Urinary Bladder Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pancreatic Diseases; Urologic Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Michael Kurman, MD

  Acepodia Biotech, Inc.

  STUDY DIRECTOR

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: March 18, 2020
• First Posted: March 24, 2020
• Study Start: June 24, 2020
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1); US (2)