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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06120075




Registration number
NCT06120075
Ethics application status
Date submitted
1/11/2023
Date registered
7/11/2023

Titles & IDs
Public title
A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
Scientific title
A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
Secondary ID [1] 0 0
ARC-27
Universal Trial Number (UTN)
Trial acronym
ARC-27
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AB801
Treatment: Drugs - Docetaxel

Experimental: Dose Escalation Cohort 1 - AB801 capsule Dose Level 1 - Participants will receive AB801 orally daily

Experimental: Dose Escalation Cohort 2 - AB801 capsule Dose Level 2 - Participants will receive AB801 orally daily

Experimental: Dose Escalation Cohort 3 - AB801 capsule Dose Level 3 - Participants will receive AB801 orally daily

Experimental: Dose Escalation Cohort 4 - AB801 capsule Dose Level 4 - Participants will receive AB801 orally daily

Experimental: Dose Escalation Cohort 5 - AB801 tablets Dose Level 5 - Participants will receive AB801 orally daily

Experimental: Dose Escalation Cohort 6 - AB801 tablets Dose Level 6 - Participants will receive AB801 orally daily

Experimental: Dose Escalation Cohort 7 - AB801 tablets Dose Level 7 - Participants will receive AB801 orally daily

Experimental: Dose Expansion Cohort - AB801 + Docetaxel - Participants with NSCLC will receive AB801 orally in combination with docetaxel IV infusion


Treatment: Drugs: AB801
Administered as specified in the treatment arm

Treatment: Drugs: Docetaxel
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
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 Plasma Drug Concentration-Time Curve (AUC)
Timepoint [1] 0 0
Predose, Up to 8 hours postdose
Secondary outcome [2] 0 0
Maximum Concentration (Cmax) in Plasma
Timepoint [2] 0 0
Predose, Up to 8 hours postdose
Secondary outcome [3] 0 0
Time to Maximum Concentration (Tmax) in Plasma
Timepoint [3] 0 0
Predose, Up to 8 hours postdose
Secondary outcome [4] 0 0
Objective response rate (ORR) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
Dose Expansion Cohorts: Duration of Response (DOR) as Assessed per RECIST v1.1
Timepoint [5] 0 0
Up to 2 years

Eligibility
Key inclusion criteria
Key

* Monotherapy-specific criteria for dose escalation cohorts:

* Participants may have cytologically or pathologically confirmed non-small cell lung carcinoma (NSCLC), colorectal carcinoma (CRC), breast, ovarian, renal cell carcinoma (RCC), head and neck squamous cell carcinoma (HNSCC), or bladder (including urothelial malignancies of the renal pelvis and ureter) carcinoma that has progressed or was non-responsive to available therapies with no standard of care (SOC) options, or for whom standard therapy has proven ineffective, intolerable, or considered inappropriate; or for whom a clinical study of an investigational agent is a recognized SOC.
* Disease-specific criteria for dose-expansion (NSCLC):

* Cytologically or pathologically confirmed locally advanced unresectable or metastatic (Stage IIIB-IV per American Joint Committee on Cancer version 8) non-squamous NSCLC negative for actionable mutations in EGFR, ALK, ROS1, NTRK, C-MET, or RET. Mixed SCLC and squamous NSCLC histology is not permitted.
* Previously treated in the unresectable locally advanced or metastatic setting with a platinum-containing chemotherapy and PD-(L)-1inhibitor.
* Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) guidance (Version 1.1) (Section 1.1). The measurable lesion must be outside of a radiation field if the participant received prior radiation unless discussed and approved by the study physician.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 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.
* Underlying medical conditions or adverse events that, in the physician or sponsor's opinion, will make the administration of investigational products hazardous.
* Prolonged QT interval defined as mean corrected QT interval (QTc) = 450 milliseconds (ms).
* 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.
* Treatment with systemic immunosuppressive medication (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor-a agents) administered within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressant medication during study treatment.

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
19/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
91
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Utah
Country [7] 0 0
United States of America
State/province [7] 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
+1-510-462-3330
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06120075