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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03255070
Registration number
NCT03255070
Ethics application status
Date submitted
14/08/2017
Date registered
21/08/2017
Date last updated
1/02/2024
Titles & IDs
Public title
A Dose-escalation, Expansion Study of ARX788, in Advanced Solid Tumors Subjects With HER2 Expression (ACE-Pan Tumor 01)
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Scientific title
A Phase 1, Multicenter, Open-label, Multiple Dose-escalation and Expansion Study of ARX788, as Monotherapy in Advanced Solid Tumors With HER2 Expression
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Secondary ID [1]
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ARX788-1711
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms
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Gastric Neoplasm
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Solid Tumors
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Condition category
Condition code
Cancer
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Breast
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Cancer
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Stomach
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ARX788
Experimental: ARX788 Phase 1a (Dose Escalation) - ARX788 will be administered every 3 weeks (Q3W) or every 4 weeks (Q4W) via intravenous (IV) infusion. Patients will be enrolled into escalating dose levels during Dose Escalation period.
Experimental: ARX788 Phase 1b (Dose Expansion) - ARX788 will be administered every 3 weeks (Q3W) via intravenous (IV) infusion. Patients will receive the maximum tolerated dose during the Dose Expansion period of the study.
Treatment: Drugs: ARX788
An antibody drug conjugate
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of subjects experiencing adverse events, frequency and seriousness of treatment emergent adverse events (TEAEs)
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Assessment method [1]
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To assess the safety, tolerability, and immunogenicity profile
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Timepoint [1]
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Day 1 through 30 days after last dose
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Primary outcome [2]
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Phase 1b: Objective response rate (ORR: complete response + partial response) per imaging assessment based on RECIST version 1.1.
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Assessment method [2]
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Number of subjects with objective response is assessed every 6-8 weeks from Cycle 1 Day 1 through disease progression.
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Timepoint [2]
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36 months
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Secondary outcome [1]
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Number of subjects with tumor response per imaging assessment based on RECIST version 1.1.
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Assessment method [1]
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The objective response rate (ORR: CR+PR) based on RECIST v1.1 will be assessed as the primary endpoint to determine the anticancer activity of ARX788 as well as best overall response.
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Timepoint [1]
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18 months
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Secondary outcome [2]
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Area under the concentration-time curve (AUC) from first infusion to subject end of study.
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Assessment method [2]
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Pharmacokinetic (PK) characteristics: ARX788 (intact ADC), total mAb, and metabolites
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Timepoint [2]
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36 months
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Secondary outcome [3]
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Half-life of ARX788 from first infusion to end of study.
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Assessment method [3]
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Pharmacokinetic (PK) characteristics: ARX788 from first infusion to subject end of study
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Timepoint [3]
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36 months
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Secondary outcome [4]
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Immunogenicity profile of ARX788
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Assessment method [4]
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Number of subjects who develop anti-ARX788 antibody
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Timepoint [4]
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36 months
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Eligibility
Key inclusion criteria
* Age >18 years
* Life expectancy >3 months.
* Female or male subjects whose advanced HER2 expressing cancer has failed standard of care treatments, or for whom such therapy is not acceptable to the subject. Subjects with advanced breast, gastric cancer, or other solid tumor who test positive for HER2 by ASCO/CAP criteria (either IHC or FISH) must have received prior treatment with a trastuzumab containing therapy. Subjects who have been previously treated with pertuzumab, TDM-1, lapatinib, or other available and accessible HER2-directed therapies or investigational therapies are eligible.
* Disease measurability:
* Phase 1a: measurable or non-measurable disease per RECIST v 1.1.
* Phase 1b: measurable disease per RECIST v 1.1 (subjects with non-measurable disease are not eligible for Phase 1b).
* Histopathologic evidence of cancer based upon pathology report.
* Tumor tissue local laboratory HER2 testing results, adequate tumor sample available for confirmation of HER2 status. Subjects with other types of cancer must have previously tested locally for HER2 status by HER2 IHC or ISH assay.
* Phase 1a: ISH positive or IHC 3+ advanced cancer (including breast or gastric/esophageal or other solid tumors).
* Phase 1b: Cohort 8 advanced breast cancer (IHC 3+ or IHC 2+/ISH); Cohort 9 advanced breast cancer (IHC 2+ / ISH-); Cohort 10 advanced gastric cancer (IHC 3+ or IHC 2+/ISH+) or gastroesophageal junction adenocarcinoma; Cohort 11 other advanced solid tumor cancers with HER2-overexpression (HER2 IHC 3+ or IHC 2+/IHS+); Cohort 12 advanced solid tumor cancers with HER2 activating mutation.
* Eastern Cooperative Oncology Group Performance Status of 0 to 1.
* Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade 0 or 1 as per the NCI-CTCAE v 4.03 (phase 1a) and v 5.0 ( Phase 1b).
* Adequate organ functions.
* Willing and able to understand and sign an informed consent inform and to comply with all aspects of the protocol.
* Female subjects must be surgically sterile, or have a monogamous partner who is surgically sterile, or at least 2 years postmenopausal, or who commits to use an acceptable form of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence) for the duration of the study and for 3 months following the last dose of study treatment.
* Male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* History of allergic reactions to any component of ARX788.
* History of ocular events, or any current ongoing active ocular infections.
* History of congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, or cardiac arrhythmia within 12 months prior to enrollment
* Grade 2 to 4 peripheral neuropathy (NCI CTCAE v 5.0)
* History of unstable central nervous system (CNS) metastases
* Current severe, uncontrolled systemic disease (eg, clinical significant cardiovascular, pulmonary, or metabolic diseases)
* Any uncontrollable intercurrent illness, infection (including subjects with active, symptomatic Covid-19 infections), or other conditions that could limit study compliance or interfere with assessments.
* 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.
* Pregnancy or breast feeding.
* Known active HCV, HBV, and/or HIV infection.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/03/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/10/2023
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Sample size
Target
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Accrual to date
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Final
106
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Research Site - East Albury
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Recruitment hospital [2]
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Research Site - North Sydney
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Recruitment hospital [3]
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Mater Misericordiae Limited - South Brisbane
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Recruitment hospital [4]
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Princess Alexandria Hospital - Woolloongabba
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Recruitment hospital [5]
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Monash Health - Clayton
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Recruitment hospital [6]
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Research Site - Frankston
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Recruitment hospital [7]
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Research Site - Nedlands
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Recruitment postcode(s) [1]
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2640 - East Albury
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Recruitment postcode(s) [2]
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2640 - North Sydney
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment postcode(s) [4]
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4102 - Woolloongabba
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Recruitment postcode(s) [5]
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3168 - Clayton
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Recruitment postcode(s) [6]
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3199 - Frankston
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Missouri
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Ohio
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United States of America
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State/province [4]
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Texas
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Ambrx, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This 2-part, Phase 1, open-label study will determine the recommended Phase 2 dose (RP2D) of ARX788 in subjects with advanced HER2 positive cancers and will assess the safety and anticancer activity in breast, gastric and other advanced HER2 positive solid tumors.
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Trial website
https://clinicaltrials.gov/study/NCT03255070
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ambrx
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Address
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Ambrx, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03255070
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