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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05536141




Registration number
NCT05536141
Ethics application status
Date submitted
7/09/2022
Date registered
10/09/2022

Titles & IDs
Public title
A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
Scientific title
A Phase 1, Open-label, Dose Escalation and Dose Expansion Study, to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB521 Monotherapy and Combination Therapies in Participants With Clear Cell Renal Cell Carcinoma and Other Solid Tumors
Secondary ID [1] 0 0
ARC-20
Universal Trial Number (UTN)
Trial acronym
ARC-20
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clear Cell Renal Cell Carcinoma 0 0
Solid Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - casdatifan
Treatment: Drugs - Cabozantinib

Experimental: Dose Escalation Cohort 1 - Participants will receive casdatifan orally once daily

Experimental: Dose Escalation Cohort 2 - Participants will receive casdatifan orally once daily

Experimental: Dose Escalation Cohort 3 - Participants will receive casdatifan orally twice daily

Experimental: Dose Escalation Cohort 4 - Participants will receive casdatifan orally

Experimental: Dose Escalation Cohort 5 - Participants will receive casdatifan orally

Experimental: Dose Expansion Cohort 1 - Participants will receive casdatifan orally

Experimental: Dose Expansion Cohort 2 - Participants will receive casdatifan orally

Experimental: Dose Expansion Cohort 3 - Participants will receive casdatifan orally

Experimental: Dose Expansion Cohort 4 - Participants will receive casdatifan orally with Cabozantinib


Treatment: Drugs: casdatifan
Administered as specified in the treatment arm

Treatment: Drugs: Cabozantinib
Administered as specified in the treatment arm
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with dose limiting toxicities (DLTs)
Timepoint [1] 0 0
Up to 4 months
Primary outcome [2] 0 0
Number of participants with adverse events (AEs)
Timepoint [2] 0 0
Up to 4 months
Secondary outcome [1] 0 0
Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [1] 0 0
Up to 4 months
Secondary outcome [2] 0 0
Plasma concentration of casdatifan
Timepoint [2] 0 0
Up to 4 months
Secondary outcome [3] 0 0
Area under the plasma concentration time curve (AUC) of casdatifan
Timepoint [3] 0 0
Up to 4 months
Secondary outcome [4] 0 0
Maximum Observed Plasma Concentration (Cmax) of casdatifan
Timepoint [4] 0 0
Up to 4 months

Eligibility
Key inclusion criteria
Key

* Disease-specific criteria for dose escalation:
* Participants may have any pathologically confirmed solid tumor type where no other treatment options are available
* Disease-specific criteria for dose-expansion:

* Histologically confirmed ccRCC
* For casdatifan monotherapy cohorts: participants must have received prior treatment in the metastatic setting with an anti-PD-1/PD-L1 therapy and a vascular endothelial growth factor receptor-targeting tyrosine kinase inhibitor (VEGFR-targeting TKI), (either individually or in combination)
* For casdatifan + cabozantinib combination therapy: participants must have received prior treatment for locally advanced or metastatic disease with anti-PD-1/PD-L1 therapy in an immediately preceding line of therapy
* Must have at least one measurable lesion per RECIST guidance
* Eastern Cooperative Oncology Group (ECOG) performance status score of = 1

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product
* Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with a participant's participation in the clinical study or make the administration of investigational product hazardous
* History of trauma or major surgery within 28 days prior to the first dose of investigational product
* For all expansion cohorts: prior treatment with an hypoxia inducible factor (HIF)-2a inhibitor. For the casdatifan + cabozantinib combination cohort, any prior treatment with cabozantinib
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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
26/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
302
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
ICON - Adelaide
Recruitment hospital [2] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 0 0
Box Hill Hospital - Melbourne
Recruitment hospital [4] 0 0
Macquarie University Hospital - Melbourne
Recruitment hospital [5] 0 0
Ashford Cancer Centre Research/ICON - Sydney
Recruitment hospital [6] 0 0
Macquarie University Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Nebraska
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Arcus Biosciences, Inc.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Arcus Biosciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Medical Director
Address 0 0
Country 0 0
Phone 0 0
+1-510-462-3330
Fax 0 0
Email 0 0
ClinicalTrialInquiry@arcusbio.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Arcus will provide access to individual de-identified participant data and related study documents \[e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)\] upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

For more information, please visit our website.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://trials.arcusbio.com/our-transparency-policy


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/NCT05536141