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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06672185
Registration number
NCT06672185
Ethics application status
Date submitted
28/10/2024
Date registered
4/11/2024
Date last updated
14/07/2025
Titles & IDs
Public title
ARC101 in Advanced Solid Tumors
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Scientific title
A Phase 1 Study of ARC101 in Advanced Solid Tumors
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Secondary ID [1]
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ARC101-P1-101
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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:
Advanced Solid Tumor
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ARC101
Experimental: Dose Escalation Cohorts - ARC101 will be administered in escalating doses, with each dose escalation cohort assessing toxicity 21 days after the initial dose.
Experimental: Dose Expansion Cohorts - ARC101 will be administered at recommended phase 2 dose(s).
Treatment: Drugs: ARC101
ARC101 will be administered according to an assigned dose schedule.
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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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Frequency and type of dose-limiting toxicities.
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Assessment method [1]
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Timepoint [1]
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Day 1-Day 21 of the first treatment cycle
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Primary outcome [2]
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Occurrence and severity of adverse events, serious adverse events and laboratory values.
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Assessment method [2]
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Timepoint [2]
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Day 1 to 100 days after the last dose of study drug.
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Secondary outcome [1]
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PK Assessment: Cmax of ARC101
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Assessment method [1]
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Measurement of Maximum Observed Concentration
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Timepoint [1]
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During the intervention/study therapy administration, approximately 1 year on average.
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Secondary outcome [2]
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PK Assessment: Cmin of ARC101
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Assessment method [2]
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Measurement of Minimum Observed Concentration
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Timepoint [2]
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During the intervention/study therapy administration, approximately 1 year on average.
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Secondary outcome [3]
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PK Assessment: Tmax of ARC101
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Assessment method [3]
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Measurement of Time to Reach Maximum Concentration
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Timepoint [3]
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During the intervention/study therapy administration, approximately 1 year on average.
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Secondary outcome [4]
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PK Assessment: AUC of ARC101
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Assessment method [4]
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Area under the plasma concentration versus time curve
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Timepoint [4]
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During the intervention/study therapy administration, approximately 1 year on average.
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Secondary outcome [5]
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Overall Response Rate
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Assessment method [5]
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Percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 and overall survival (OS)
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Timepoint [5]
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During the intervention/study therapy administration, approximately 1 year on average.
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Secondary outcome [6]
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Duration of Response
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Assessment method [6]
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Time from first objective response to disease progression per RECIST 1.1 or death to any cause
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Timepoint [6]
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During the intervention/study therapy administration, approximately 1 year on average.
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Secondary outcome [7]
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Progression-Free Survival
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Assessment method [7]
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PFS is defined as the time from the start of the treatment until objective disease progression per PFS is defined as the time from the start of the treatment until objective disease progression per RECIST 1.1 or death from any cause
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Timepoint [7]
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During the intervention/study therapy administration, approximately 1 year on average.
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Secondary outcome [8]
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Number of anti-drug antibody (ADA) Positive Participants
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Assessment method [8]
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Immunogenicity will be measured by the number of participants that are ADA positive.
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Timepoint [8]
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During the intervention/study therapy administration, approximately 1 year on average.
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Eligibility
Key inclusion criteria
* Locally advanced or metastatic solid tumor ovarian, testicular or other Claudin 6+ cancers
* Measurable or evaluable disease, per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate organ function
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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
* Active CNS involvement
* Malignancy diagnosis other than the disease under study within 2 years prior to the first dose of study drug.
* Presence of uncontrolled ascites
* Toxicity related to prior anticancer therapy that has not returned to Grade =1 or baseline levels
* Clinically significant pulmonary compromise
* Active autoimmune disease within 12 months prior to first dose of study drug.
* Female participant who is pregnant, breastfeeding, or plans to become pregnant or male participant who plans to father a child either while enrolled or within 90 days after the final administration of study drug.
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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
Recruiting
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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
5/02/2025
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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
1/08/2028
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Actual
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Sample size
Target
70
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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Recruitment hospital [1]
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Sunshine Coast University Private Hospital - Birtinya
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Recruitment hospital [2]
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Cancer Research SA - Adelaide
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Recruitment hospital [3]
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Cabrini Health Research - Malvern
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Recruitment postcode(s) [1]
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4575 - Birtinya
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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3144 - Malvern
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Michigan
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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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Texas
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Country [3]
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Canada
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State/province [3]
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British Columbia
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Country [4]
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Canada
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State/province [4]
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Ontario
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Third Arc Bio
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ARC101 in patients with advanced cancer.
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Trial website
https://clinicaltrials.gov/study/NCT06672185
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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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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 public queries
Name
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VP Clinical Operations
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Address
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Country
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Phone
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267-589-9444
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Fax
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Email
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[email protected]
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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/NCT06672185
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