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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-05

Study Completion Date

2022-04-20

Brief Summary

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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)

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Detailed Description

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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

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HER2 Mutation-Related Tumors HER2 Amplified Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

ARX788 will be administered by intravenous (IV) infusion every 3 weeks (Q3W).

Interventions

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ARX788

ARX788 will be administered by intravenous (IV) infusion every 3 weeks (Q3W).

Intervention Type DRUG

Other Intervention Names

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ADC

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No