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

Ambrx

Status and phase: Withdrawn; Phase 2

Conditions: HER2 Amplified Solid Tumors; HER2 Mutation-Related Tumors

Treatments: Drug: ARX788

Study type: Interventional

Funder types: Industry

Identifiers

NCT05041972

ACE-Pan tumor-02

Details and patient eligibility

About

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)

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years and older
• Life expectancy > 3 months
• Eastern Cooperative Oncology Performance Status ≤ 1
• HER2 status must be determined from a local Clinical Laboratory Improvement Amendments (CLIA) or equivalent-certified laboratory.
• Cohort 1, Cohort 2, and Explanatory Cohort A: HER2 mutated subjects with pre-specified HER2 activating mutation. Subjects with HER2 mutations in NSCLC (Cohort 1), breast cancer (Cohort 2), and other solid tumors (Cohort A) who have not received prior HER2 antibody drug conjugate (ADC) treatment are eligible.
• Cohort 3: Subjects with HER2 amplifications in biliary tract cancers (BTC) who have not received prior HER2 ADC treatment are eligible.
• Cohort 4: Subjects with HER2 amplifications in colorectal cancer (CRC), ovarian, endometrial, NSCLC and other solid tumors who have not received prior HER2 ADC treatment are eligible.
• Cohort 5 HER2 mutation or HER2 amplification: subjects with HER2 mutated or amplified tumors and have been previously treated with HER2 ADC are eligible.
• Subjects who are resistant or refractory to previous standard care of treatment.
• Subjects with stable brain metastases.
• Adequate organ functions.

Exclusion criteria

Any subject who meets any of the following criteria is excluded from the study:

• For Cohort 4: breast and gastric/GEJ cancer are excluded.
• Prior history of interstitial lung disease, pneumonitis, or other clinically significant lung disease within 12 months.
• History of ocular events, any current ongoing active ocular infections, or any chronic corneal disease unless approved by Medical Monitor.
• Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 14 days before the first dose of ARX788.
• Clinically significant surgical intervention (excluding diagnostic biopsy) within 21 days of the first dose of ARX788.
• Radiotherapy administered less than 21 days prior to the first dose of ARX788, or localized palliative radiotherapy administered less than 7 days prior to the first dose of ARX788, or radiotherapy-induced toxicity of Grade 2 or greater based on NCI-CTCAE v 5.0.

There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 6 patient groups

Cohort 1: HER2 Mutated Non-Small Cell Lung Cancer (NSCLC)

Experimental group

Description:

Intervention: Drug: ARX788

Treatment:

Drug: ARX788

Cohort 2: HER2 Mutation Breast Cancer

Experimental group

Description:

Intervention: Drug: ARX788

Treatment:

Drug: ARX788

Exploratory Cohort A: Other HER2-Mutated tumors

Experimental group

Description:

Intervention: Drug: ARX788

Treatment:

Drug: ARX788

Cohort 3: HER2 Amplification Biliary Tract Cancer (BTC)

Experimental group

Description:

Intervention: Drug: ARX788

Treatment:

Drug: ARX788

Cohort 4 HER2 Amplification Colorectal (CRC), Ovarian Endometrial, NSCLC, and other solid tumors

Experimental group

Description:

Intervention: Drug: ARX788

Treatment:

Drug: ARX788

Cohort 5: HER2 Mutation or HER2 Amplification Solid Tumors

Experimental group

Description:

Intervention: Drug: ARX788

Treatment:

Drug: ARX788