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

Acepodia Biotech

Status and phase: Enrolling; Phase 1

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

Treatments: Drug: Fludarabine; Drug: ACE1702; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04319757

ACE1702-001

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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36 participants in 6 patient groups

ACE1702 Dose Level 1

Experimental group

Description:

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

Treatment:

Drug: Cyclophosphamide

Drug: ACE1702

Drug: Fludarabine

ACE1702 Dose Level 2

Experimental group

Description:

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

Treatment:

Drug: Cyclophosphamide

Drug: ACE1702

Drug: Fludarabine

ACE1702 Dose Level 3

Experimental group

Description:

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

Treatment:

Drug: Cyclophosphamide

Drug: ACE1702

Drug: Fludarabine

ACE1702 Dose Level 4

Experimental group

Description:

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

Treatment:

Drug: Cyclophosphamide

Drug: ACE1702

Drug: Fludarabine

ACE1702 Dose Level 5

Experimental group

Description:

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

Treatment:

Drug: Cyclophosphamide

Drug: ACE1702

Drug: Fludarabine

ACE1702 Dose 6

Experimental group

Description:

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

Treatment:

Drug: Cyclophosphamide

Drug: ACE1702

Drug: Fludarabine