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

A

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)

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

Trial contacts and locations

3

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Central trial contact

Janet Pan, MPH

Data sourced from clinicaltrials.gov

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