Advanced Cancer
Conditions
Keywords
AB801, Non-small cell lung cancer (NSCLC)
Brief 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.
Interventions
DRUGAB801
Administered as specified in the treatment arm
DRUGDocetaxel
Administered as specified in the treatment arm
Sponsors
Arcus Biosciences, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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 (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
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events | Up to 2 years |
| Dose Escalation Cohorts: Number of Participants With Dose-Limiting Toxicities (DLTs) | Up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Area Under the Plasma Drug Concentration-Time Curve (AUC) | Predose, Up to 8 hours postdose |
| Maximum Concentration (Cmax) in Plasma | Predose, Up to 8 hours postdose |
| Time to Maximum Concentration (Tmax) in Plasma | Predose, Up to 8 hours postdose |
| Objective response rate (ORR) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 2 years |
| Dose Expansion Cohorts: Duration of Response (DOR) as Assessed per RECIST v1.1 | Up to 2 years |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Arcus Biosciences
Outcome results
None listed