NCT05041972

ARX788 in Selected HER2-mutated or HER2-amplified/Overexpressed Solid Tumors (ACE-Pan Tumor-02)

A Global Phase 2 Study to Evaluate the Efficacy and Safety of ARX788 for Selected HER2-mutated or HER2-amplified/Overexpressed Solid Tumors

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ambrx, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Global Phase 2 Study to Evaluate the Efficacy and Safety of ARX788 for Selected HER2-mutated or HER2-amplified/overexpressed Solid Tumors (ACE-Pan tumor-02)

Detailed description

The study will enroll subjects with HER2-mutated or HER2-amplified/overexpressed locally advanced or metastatic solid tumor cancers whose prior standard of care therapies have failed. This basket trial will evaluate ARX788 across multiple cancer populations, as defined by HER2 genetic biomarkers

Conditions

• HER2 Mutation-Related Tumors
• HER2 Amplified Solid Tumors

Interventions

Type	Name	Description
DRUG	ARX788	ARX788 will be administered by intravenous (IV) infusion every 3 weeks (Q3W).

Timeline

• Start date: 2021-11-05
• Primary completion: 2022-04-20
• Completion: 2022-04-20
• First posted: 2021-09-13
• Last updated: 2022-09-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study