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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

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

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Michael Kurman, MD

Role: Study Director

Affiliation: Acepodia Biotech, Inc.

Overall Contact

Name: Janet Pan, MPH

Phone: +1-415-839-6787

Email: clinical@acepodiabio.com

LOCATION