Clinical trial NCT06120075: A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
Official title: A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Cancer
Keywords: AB801
Non-small cell lung cancer (NSCLC)
Lead sponsor: Arcus Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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 (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/Exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Up to 2 years
measure: Dose Escalation Cohorts: Number of Participants With Dose-Limiting Toxicities (DLTs)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Area Under the Plasma Drug Concentration-Time Curve (AUC)
timeFrame: Predose, Up to 8 hours postdose
measure: Maximum Concentration (Cmax) in Plasma
timeFrame: Predose, Up to 8 hours postdose
measure: Time to Maximum Concentration (Tmax) in Plasma
timeFrame: Predose, Up to 8 hours postdose
measure: Objective response rate (ORR) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: Up to 2 years
measure: Dose Expansion Cohorts: Duration of Response (DOR) as Assessed per RECIST v1.1
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Denver
country: United States
facility: Sarah Cannon Research Institute
state: Colorado
city: Washington
country: United States
facility: Georgetown
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai/ The Tisch Cancer Center
state: New York
city: Philadelphia
country: United States
facility: University Of Pennsylvania, Abramson Cancer Center
state: Pennsylvania
city: Dallas
country: United States
facility: Mary Crowley
state: Texas
city: San Antonio
country: United States
facility: START - South Texas Accelerated Research Therapeutics, LLC.
state: Texas
city: West Valley City
country: United States
facility: START Mountain Region
state: Utah
city: Fairfax
country: United States
facility: Next Oncology Virginia
state: Virginia
Study officials:
affiliation: Arcus Biosciences
name: Medical Director
role: STUDY_DIRECTOR
References: