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HER2 Mutation-Related TumorsPhase 2NCT05041972

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

A Phase 2 study testing ARX788 in people with HER2 Mutation-Related Tumors and HER2 Amplified Solid Tumors, run by Ambrx, Inc. at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ARX788
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesUnited States
Study dates
5 Nov 2021to 20 Apr 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

United States2 sites

  • AMR Kansas City

    Kansas City, Missouri, 64114

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

Other trials in United States

About this study

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

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)

Read the 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

Being tested
ARX788
Keywords
HER2 Mutation, HER2 Amplification, Non-Small Cell Lung Cancer (NSCLC), Colorectal (CRC), Biliary Tract Cancer (BTC), Breast Cancer, Other Solid Tumors
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Biliary Tract Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARX788Drug

    Also called ADC

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

Study groups in NCT05041972
Study groupRoleWhat they receive
Cohort 1: HER2 Mutated Non-Small Cell Lung Cancer (NSCLC)ExperimentalIntervention: Drug: ARX788
Receives: Drug: ARX788
Cohort 2: HER2 Mutation Breast CancerExperimentalIntervention: Drug: ARX788
Receives: Drug: ARX788
Exploratory Cohort A: Other HER2-Mutated tumorsExperimentalIntervention: Drug: ARX788
Receives: Drug: ARX788
Cohort 3: HER2 Amplification Biliary Tract Cancer (BTC)ExperimentalIntervention: Drug: ARX788
Receives: Drug: ARX788
Cohort 4 HER2 Amplification Colorectal (CRC), Ovarian Endometrial, NSCLC, and other solid tumorsExperimentalIntervention: Drug: ARX788
Receives: Drug: ARX788
Cohort 5: HER2 Mutation or HER2 Amplification Solid TumorsExperimentalIntervention: Drug: ARX788
Receives: Drug: ARX788

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (9)

  1. Duration of Response

    DOR is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first, will be computed for subjects with a BOR of CR or PR.

    Measured: 1 year

  2. Best Overall Response (BOR)

    BOR is defined as the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).

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

  3. Disease Control Rate (DCR)

    DCR is defined as the proportion of complete response (CR), partial response (PR), and stable disease (SD) rates.

    Measured: 2 years

  4. Progression Free Survival (PFS)

    PFS is defined as the time between date of first dose of study therapy and date of progression or death.

    Measured: 2 years

  5. Overall Survival (OS)

    Overall survival (OS) is defined as the time from first dose of study therapy to the date of death (any cause).

    Measured: 2 years

  6. Time to Response (TTR)

    Time to response (TTR) is defined as the time from the start of treatment to the first objective tumor response

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

  7. Maximum serum concentration (Cmax) for ARX788, total antibody, and metabolites

    Pharmacokinetic parameter maximum serum concentration (Cmax) for ARX788, total antibody, and metabolites.

    Measured: Cycle 1 and Cycle 3

  8. Trough concentration (Ctrough) for ARX788, total antibody, and metabolites

    Pharmacokinetic parameter trough concentration (Ctrough) for ARX788, total antibody, and metabolites.

    Measured: Cycle 1 and Cycle 3

  9. Incidence of anti-drug antibodies (ADAs)

    Incidence of anti-drug antibodies (ADAs) following intravenous administration of ARX788 in participants with HER2-mutated or HER2-amplified locally advanced or metastatic solid tumors.

    Measured: Predose at every cycle (each cycle is 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2021
  2. Study start5 Nov 2021
  3. Primary completion20 Apr 2022
  4. Study completion20 Apr 2022

Why it stopped: Business strategy change

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05041972
Sponsor's protocol ID
ACE-Pan tumor-02
Status last verified
Apr 2022
First submitted
3 Sep 2021
Last updated
13 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ARX788 in people with HER2 Mutation-Related Tumors and HER2 Amplified Solid Tumors, run by Ambrx, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: At the end of every 2 cycles (each cycle is 21 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05041972.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.

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