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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05891171




Registration number
NCT05891171
Ethics application status
Date submitted
26/05/2023
Date registered
6/06/2023

Titles & IDs
Public title
Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers
Scientific title
A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
Secondary ID [1] 0 0
ARC-25
Universal Trial Number (UTN)
Trial acronym
ARC-25
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 0 0
Advanced Malignancies 0 0
Bladder Cancer 0 0
Cervical Cancer 0 0
Esophageal Cancer 0 0
Gastric Cancer 0 0
Gastroesophageal-junction Cancer (GEJ) 0 0
Head and Neck Squamous Cell Carcinoma (HNSCC) 0 0
Non-Small Cell Lung Cancer (NSCLC) 0 0
Ovarian Cancer 0 0
Renal Cell Carcinoma (RCC) 0 0
Triple Negative Breast Cancer (TNBC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AB598
Treatment: Drugs - Zimberelimab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Fluorouracil
Treatment: Drugs - Leucovorin
Treatment: Drugs - Oxaliplatin

Experimental: Dose Escalation Cohort 1 - Participants will receive AB598 intravenous (IV) infusion once every 3 weeks

Experimental: Dose Escalation Cohort 2 - Participants will receive AB598 IV infusion once every 3 weeks

Experimental: Dose Escalation Cohort 3 - Participants will receive AB598 IV infusion once every 3 weeks

Experimental: Dose Escalation Cohort 4 - Participants will receive AB598 IV infusion once every 3 weeks

Experimental: Dose Expansion Cohort 1 NSCLC - Participants will receive AB598 IV infusion in combination with zimberelimab and carboplatin/pemetrexed once every 3 weeks, for up to 2 years

Experimental: Dose Expansion Cohort 2 Gastric/GEJ Cancer - Participants will receive AB598 IV infusion every 2 weeks in combination with zimberelimab once every 4 weeks, and FOLFOX (oxaliplatin, leucovorin, fluorouracil) every 2 weeks, for up to 2 years


Treatment: Drugs: AB598
Administered as specified in the treatment arm

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

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

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

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

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

Treatment: Drugs: Oxaliplatin
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 Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Up to 2 years
Primary outcome [2] 0 0
Dose Escalation Cohorts: Number of Participants with Dose-Limiting Toxicities (DLTs)
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [1] 0 0
Area Under the Concentration-Time Curve from Administration ("0") to the Time That the Drug is No Longer Present in the Body ("infinity") (AUC 0-inf) in Whole Blood and Plasma
Timepoint [1] 0 0
Predose, Up to 4 hours postdose
Secondary outcome [2] 0 0
Maximum Concentration (Cmax) in Whole Blood and Plasma
Timepoint [2] 0 0
Predose, Up to 4 hours postdose
Secondary outcome [3] 0 0
Time to Maximum Concentration (Tmax) in Whole Blood and Plasma
Timepoint [3] 0 0
Predose, Up to 4 hours postdose
Secondary outcome [4] 0 0
Number of Participants Who Test Positive for Antidrug Antibodies (ADAs) to AB598
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
Objective Response Rate (ORR)
Timepoint [5] 0 0
Up to 2 years
Secondary outcome [6] 0 0
Dose Expansion Cohorts: Duration of Response (DOR)
Timepoint [6] 0 0
Up to 2 years

Eligibility
Key inclusion criteria
Key

* Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) guidance
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Monotherapy-specific criteria for dose escalation cohorts:

* Participants may have any pathologically confirmed advanced or metastatic solid tumor malignancy for which standard therapy has proven ineffective, intolerable, or considered inappropriate
* Disease-specific criteria for dose-expansion Cohort 1 (NSCLC):

* Histologically confirmed, documented diagnosis of locally advanced unresectable or metastatic non-squamous NSCLC
* Treatment-naive in the unresectable locally advanced or metastatic setting
* Cannot have progressed within 6 months of prior platinum-based chemotherapy for earlier stage disease
* Mixed small-cell lung cancer histology is not permitted
* Disease-specific criteria for dose expansion Cohort 2 (Gastric/GEJ):

* Histologically confirmed, documented diagnosis of human epidermal growth factor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma
* No prior systemic treatment for locally advanced unresectable or metastatic disease
* Cannot have progressed within 6 months of prior platinum-based chemotherapy for earlier stage disease

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 study
* Underlying medical conditions or AEs that, in the investigator's or sponsor's opinion, will make the administration of the study drugs hazardous
* Any active or documented history of autoimmune disease including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment
* History of trauma or major surgery within 28 days prior to the first dose of study drug
* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressant medication during study treatment with certain protocol specified exceptions

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
13/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
81
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Queen Elizabeth Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia

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
1-888-44-ARCUS
Fax 0 0
Email 0 0
[email protected]
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/NCT05891171