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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
6/03/2025

Titles & IDs
Public title
ARC101 in Advanced Solid Tumors
Scientific title
A Phase 1 Study of ARC101 in Advanced Solid Tumors
Secondary ID [1] 0 0
ARC101-P1-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency and type of dose-limiting toxicities.
Timepoint [1] 0 0
Day 1-Day 21 of the first treatment cycle
Primary outcome [2] 0 0
Occurrence and severity of adverse events, serious adverse events and laboratory values.
Timepoint [2] 0 0
Day 1 to 100 days after the last dose of study drug.
Secondary outcome [1] 0 0
PK Assessment: Cmax of ARC101
Timepoint [1] 0 0
During the intervention/study therapy administration, approximately 1 year on average.
Secondary outcome [2] 0 0
PK Assessment: Cmin of ARC101
Timepoint [2] 0 0
During the intervention/study therapy administration, approximately 1 year on average.
Secondary outcome [3] 0 0
PK Assessment: Tmax of ARC101
Timepoint [3] 0 0
During the intervention/study therapy administration, approximately 1 year on average.
Secondary outcome [4] 0 0
PK Assessment: AUC of ARC101
Timepoint [4] 0 0
During the intervention/study therapy administration, approximately 1 year on average.
Secondary outcome [5] 0 0
Overall Response Rate
Timepoint [5] 0 0
During the intervention/study therapy administration, approximately 1 year on average.
Secondary outcome [6] 0 0
Duration of Response
Timepoint [6] 0 0
During the intervention/study therapy administration, approximately 1 year on average.
Secondary outcome [7] 0 0
Progression-Free Survival
Timepoint [7] 0 0
During the intervention/study therapy administration, approximately 1 year on average.
Secondary outcome [8] 0 0
Number of anti-drug antibody (ADA) Positive Participants
Timepoint [8] 0 0
During the intervention/study therapy administration, approximately 1 year on average.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2028
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Cancer Research SA - Adelaide
Recruitment hospital [2] 0 0
Cabrini Health Research - Malvern
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3144 - Malvern

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Third Arc Bio
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
VP Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
267-589-9444
Fax 0 0
Email 0 0
[email protected]
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