NCT05041972

Brief 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)

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

November 5, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2022

Completed
Last Updated

September 13, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

September 3, 2021

Last Update Submit

September 9, 2022

Conditions

HER2 Mutation-Related TumorsHER2 Amplified Solid Tumors

Keywords

HER2 MutationHER2 AmplificationNon-Small Cell Lung Cancer (NSCLC)Colorectal (CRC)Biliary Tract Cancer (BTC)Breast CancerOther Solid Tumors

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR)

    The confirmed objective response rate (ORR) of ARX788 by blinded independent central review (BICR) based on RECIST 1.1 in Cohorts 1-5. The ORR is defined as the number of subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable subjects

    At the end of every 2 cycles (each cycle is 21 days)

Secondary Outcomes (9)

  • Duration of Response

    1 year

  • Best Overall Response (BOR)

    At the end of every 2 cycles (each cycle is 21 days)

  • Disease Control Rate (DCR)

    2 years

  • Progression Free Survival (PFS)

    2 years

  • Overall Survival (OS)

    2 years

  • +4 more secondary outcomes

Study Arms (6)

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

EXPERIMENTAL

Intervention: Drug: ARX788

Drug: ARX788

Cohort 2: HER2 Mutation Breast Cancer

EXPERIMENTAL

Intervention: Drug: ARX788

Drug: ARX788

Exploratory Cohort A: Other HER2-Mutated tumors

EXPERIMENTAL

Intervention: Drug: ARX788

Drug: ARX788

Cohort 3: HER2 Amplification Biliary Tract Cancer (BTC)

EXPERIMENTAL

Intervention: Drug: ARX788

Drug: ARX788

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

EXPERIMENTAL

Intervention: Drug: ARX788

Drug: ARX788

Cohort 5: HER2 Mutation or HER2 Amplification Solid Tumors

EXPERIMENTAL

Intervention: Drug: ARX788

Drug: ARX788

Interventions

ARX788DRUG

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

Also known as: ADC
Cohort 1: HER2 Mutated Non-Small Cell Lung Cancer (NSCLC)Cohort 2: HER2 Mutation Breast CancerCohort 3: HER2 Amplification Biliary Tract Cancer (BTC)Cohort 4 HER2 Amplification Colorectal (CRC), Ovarian Endometrial, NSCLC, and other solid tumorsCohort 5: HER2 Mutation or HER2 Amplification Solid TumorsExploratory Cohort A: Other HER2-Mutated tumors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

AMR Kansas City

Kansas City, Missouri, 64114, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungBiliary Tract NeoplasmsBreast Neoplasms

Interventions

ARX788

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesDigestive System NeoplasmsBiliary Tract DiseasesDigestive System DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Global Trial Lead

    Ambrx, Inc.

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2021

First Posted

September 13, 2021

Study Start

November 5, 2021

Primary Completion

April 20, 2022

Study Completion

April 20, 2022

Last Updated

September 13, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available after the studies for which the medicine and indication have received marketing approval in European Union (EU) and United States (US) or regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

Locations

US(2)