Clinical trial NCT05891171: Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers
Official title: A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Cancer
Advanced Malignancies
Bladder Cancer
Cervical Cancer
Esophageal Cancer
Gastric Cancer
Gastroesophageal-junction Cancer (GEJ)
Head and Neck Squamous Cell Carcinoma (HNSCC)
Non-Small Cell Lung Cancer (NSCLC)
Ovarian Cancer
Renal Cell Carcinoma (RCC)
Triple Negative Breast Cancer (TNBC)
Keywords: AB598
AB122
Zimberelimab
Lead sponsor: Arcus Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-06
Enrollment: 87
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 AB598 in participants with advanced malignancies.


Eligibility criteria: Key Inclusion Criteria:

* 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
* Prior systemic radiation or whole brain radiation therapy must have been completed at least 4 weeks before investigational product (IP) administration. Other palliative radiotherapy must be completed 2 weeks before investigational product administration, if radiation therapy-related AEs have resolved to Grade ≤ 1.
* Monotherapy-specific criteria for dose escalation and PD cohorts:

  * Dose Escalation: Participants may have any pathologically confirmed advanced or metastatic solid tumor for which standard therapy has proven ineffective, intolerable, or is considered inappropriate.
  * Pharmacodynamic Cohorts: Participants may have any pathologically confirmed advanced or metastatic solid tumors for which standard therapy has proven ineffective, intolerable, or is considered inappropriate. Participants must be able to undergo collection of a fresh frozen biopsy during screening, as well as provide an on-treatment fresh frozen biopsy.
* Dose Expansion cohort criteria:

  * Histologically confirmed, documented diagnosis of 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 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 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.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
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 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
timeFrame: Predose, Up to 4 hours post dose
measure: Maximum Concentration (Cmax) in Whole Blood and Plasma
timeFrame: Predose, Up to 4 hours post dose
measure: Time to Maximum Concentration (Tmax) in Whole Blood and Plasma
timeFrame: Predose, Up to 4 hours post dose
measure: Number of Participants Who Test Positive for Antidrug Antibodies (ADAs) to AB598
timeFrame: Up to 2 years
measure: Objective Response Rate (ORR)
timeFrame: Up to 2 years
measure: Dose Expansion Cohort: Duration of Response (DOR)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Santa Monica
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Santa Rosa
country: United States
facility: Providence Medical Group Santa Rosa - Cancer Center
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Lake City
country: United States
facility: Lake City Cancer Care, LLC.
state: Florida
city: Hinsdale
country: United States
facility: Affinity Health Hope and Healing Cancer Services, LLC
state: Illinois
city: Goshen
country: United States
facility: Goshen Center for Cancer Care
state: Indiana
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Canton
country: United States
facility: Gabrail Cancer Center (GCC) Canton Facility
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Irving
country: United States
facility: Next Oncology Dallas
state: Texas
city: Fairfax
country: United States
facility: Next Oncology Virginia
state: Virginia
city: Adelaide
country: Australia
facility: Adelaide Cancer Research
city: Adelaide
country: Australia
facility: Queen Elizabeth Hospital
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan City
country: Taiwan
facility: Linkou Branch Chang Gung Memorial Hospital
Study officials:
affiliation: Arcus Biosciences
name: Medical Director
role: STUDY_DIRECTOR
References: