Trial Title:
A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
NCT ID:
NCT06120075
Condition:
Advanced Cancer
Conditions: Official terms:
Neoplasms
Docetaxel
Conditions: Keywords:
AB801
Non-small cell lung cancer (NSCLC)
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AB801
Description:
Administered as specified in the treatment arm
Arm group label:
Dose Escalation Cohort 1 - AB801 Dose Level 1
Arm group label:
Dose Escalation Cohort 2 - AB801 Dose Level 2
Arm group label:
Dose Escalation Cohort 3 - AB801 Dose Level 3
Arm group label:
Dose Escalation Cohort 4 - AB801 Dose Level 4
Arm group label:
Dose Escalation Cohort 5 - AB801 Dose Level 5
Arm group label:
Dose Escalation Cohort 6 - AB801 Dose Level 6
Arm group label:
Dose Expansion Cohort 1- AB801 + Zimberelimab + Docetaxel
Arm group label:
Dose Expansion Cohort 2 - AB801 + Docetaxel
Intervention type:
Drug
Intervention name:
Zimberelimab
Description:
Administered as specified in the treatment arm
Arm group label:
Dose Expansion Cohort 1- AB801 + Zimberelimab + Docetaxel
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Administered as specified in the treatment arm
Arm group label:
Dose Expansion Cohort 1- AB801 + Zimberelimab + Docetaxel
Arm group label:
Dose Expansion Cohort 2 - AB801 + Docetaxel
Summary:
The primary purpose of this study is to assess the safety and tolerability of AB801 in
participants with advanced malignancies, and to determine a recommended AB801 dose for
expansion.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- 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
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 Cohort 1 (STK11m [mutated or deleted]
NSCLC):
- Cytologically or pathologically confirmed locally advanced unresectable or
metastatic (Stage IIIB-IV per American Joint Committee on Cancer [AJCC] version
8) non-squamous NSCLC with documented mutation or deletion in the STK11 gene.
- Negative for actionable mutations including epidermal growth factor receptor
(EGFR), anaplastic lymphoma kinase (ALK), c-ros oncogene 1 (ROS1), neurotrophic
tyrosine receptor kinase (NTRK), mesenchymal-epithelial transition factor
(C-MET) or ret proto-oncogene (RET). Mixed small-cell lung carcinoma (SCLC) and
squamous NSCLC histology is not permitted.
- Previously treated in the unresectable locally advanced or metastatic setting
with a platinum-containing chemotherapy and programmed cell death ligand-1
(PD-L1) inhibitor.
- Disease-specific criteria for dose-expansion Cohort 2 (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 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-α 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Facility:
Name:
Georgtown
Address:
City:
Washington
Zip:
20007
Country:
United States
Status:
Recruiting
Facility:
Name:
Emory University
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Facility:
Name:
START MIdwest
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Status:
Recruiting
Facility:
Name:
Icahn School of Medicine at Mount Sinai/ The Tisch Cancer Cente
Address:
City:
New York
Zip:
10128
Country:
United States
Status:
Recruiting
Facility:
Name:
University Of Pennsylvania, Abramson Cancer Center
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Facility:
Name:
Mary Crowley
Address:
City:
Dallas
Zip:
75230
Country:
United States
Status:
Recruiting
Facility:
Name:
START - South Texas Accelerated Research Theraputics, LLC.
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
START Mountain Region
Address:
City:
West Valley City
Zip:
84119
Country:
United States
Status:
Recruiting
Facility:
Name:
Next Oncology Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Start date:
January 19, 2024
Completion date:
November 2026
Lead sponsor:
Agency:
Arcus Biosciences, Inc.
Agency class:
Industry
Source:
Arcus Biosciences, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06120075
