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ARX788 in Selected HER2-mutated or HER2-amplified Solid Tumors

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ClinicalTrials.gov Identifier: NCT05041972
Recruitment Status : Not yet recruiting
First Posted : September 13, 2021
Last Update Posted : September 13, 2021
Sponsor:
Information provided by (Responsible Party):
Ambrx, Inc.

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

Condition or disease Intervention/treatment Phase
HER2 Mutation-Related Tumors HER2 Amplified Solid Tumors Drug: ARX788 Phase 2

Detailed Description:
The study will enroll subjects with HER2-mutated or HER2-amplified 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

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Study Type : Interventional
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Global Phase 2 Study to Evaluate the Efficacy and Safety of ARX788 for Selected HER2-mutated or HER2-amplified Solid Tumors
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1: HER2 Mutated Non-Small Cell Lung Cancer (NSCLC)
Intervention: Drug: ARX788
Drug: ARX788
ARX788 will be administered by intravenous (IV) infusion every 4 weeks (Q4W).
Other Name: ADC

Experimental: Cohort 2: HER2 Mutation Breast Cancer
Intervention: Drug: ARX788
Drug: ARX788
ARX788 will be administered by intravenous (IV) infusion every 4 weeks (Q4W).
Other Name: ADC

Experimental: Exploratory Cohort A: Other HER2-Mutated tumors
Intervention: Drug: ARX788
Drug: ARX788
ARX788 will be administered by intravenous (IV) infusion every 4 weeks (Q4W).
Other Name: ADC

Experimental: Cohort 3: HER2 Amplification Biliary Tract Cancer (BTC)
Intervention: Drug: ARX788
Drug: ARX788
ARX788 will be administered by intravenous (IV) infusion every 4 weeks (Q4W).
Other Name: ADC

Experimental: Cohort 4 HER2 Amplification Colorectal (CRC), Ovarian Endometrial, NSCLC, and other solid tumors
Intervention: Drug: ARX788
Drug: ARX788
ARX788 will be administered by intravenous (IV) infusion every 4 weeks (Q4W).
Other Name: ADC

Experimental: Cohort 5: HER2 Mutation or HER2 Amplification Solid Tumors
Intervention: Drug: ARX788
Drug: ARX788
ARX788 will be administered by intravenous (IV) infusion every 4 weeks (Q4W).
Other Name: ADC




Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 2 years ]

    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



Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: 2 years ]
    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.

  2. Best Overall Response (BOR) [ Time Frame: 2 years ]
    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).

  3. Disease Control Rate (DCR) [ Time Frame: 2 years ]
    DCR is defined as the proportion of complete response (CR), partial response (PR), and stable disease (SD) rates.

  4. Progression Free Survival (PFS) [ Time Frame: 2 years ]
    PFS is defined as the time between date of first dose of study therapy and date of progression or death.

  5. Overall Survival (OS) [ Time Frame: 2 years ]
    Overall survival (OS) is defined as the time from first dose of study therapy to the date of death (any cause).

  6. Time to Response (TTR) [ Time Frame: 2 years ]
    Time to response (TTR) is defined as the time from the start of treatment to the first objective tumor response

  7. Maximum serum concentration (Cmax) for ARX788, total antibody, and metabolites [ Time Frame: Cycle 1 and Cycle 3 (each cycle is 28 days) ]
    Pharmacokinetic parameter maximum serum concentration (Cmax) for ARX788, total antibody, and metabolites.

  8. Trough concentration (Ctrough) for ARX788, total antibody, and metabolites [ Time Frame: Cycle 1 and Cycle 3 (each cycle is 28 days) ]
    Pharmacokinetic parameter trough concentration (Ctrough) for ARX788, total antibody, and metabolites.

  9. Incidence of anti-drug antibodies (ADAs) [ Time Frame: 2 years ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, or any current ongoing active ocular infections.
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05041972


Contacts
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Contact: Trial Inquiry 858-875-2400 ACEPan02trialinquiry@ambrx.com
Contact: Ambrx Study Director

Sponsors and Collaborators
Ambrx, Inc.
Investigators
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Study Director: Global Trial Lead Ambrx, Inc.
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Responsible Party: Ambrx, Inc.
ClinicalTrials.gov Identifier: NCT05041972    
Other Study ID Numbers: ACE-Pan tumor-02
First Posted: September 13, 2021    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ambrx, Inc.:
HER2 Mutation
HER2 Amplification
Non-Small Cell Lung Cancer (NSCLC)
Colorectal (CRC)
Biliary Tract Cancer (BTC)
Breast Cancer
Other Solid Tumors
Additional relevant MeSH terms:
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Neoplasms