A Dose-escalation, Expansion Study of ARX788, in Advanced Solid Tumors Subjects With HER2 Expression (ACE-Pan Tumor 01)
NCT03255070 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 106
Last updated 2024-02-01
Summary
This 2-part, Phase 1, open-label study will determine the recommended Phase 2 dose (RP2D) of ARX788 in subjects with advanced HER2 positive cancers and will assess the safety and anticancer activity in breast, gastric and other advanced HER2 positive solid tumors.
Conditions
- Breast Neoplasms
- Gastric Neoplasm
- Solid Tumors
Interventions
- DRUG
-
ARX788
An antibody drug conjugate
Sponsors & Collaborators
-
Ambrx, Inc.
lead INDUSTRY
Principal Investigators
-
Ambrx · Ambrx, Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-03-20
- Primary Completion
- 2023-09-13
- Completion
- 2023-10-18
- FDA Drug
- Yes
Countries
- United States
- Australia
Study Locations
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