ACTIVE_NOT_RECRUITING

Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers

Talk to us

Conditions

Advanced CancerAdvanced MalignanciesBladder CancerCervical CancerEsophageal CancerGastric CancerGastroesophageal-junction Cancer (GEJ)Head and Neck Squamous Cell Carcinoma (HNSCC)Non-Small Cell Lung Cancer (NSCLC)Ovarian CancerRenal Cell Carcinoma (RCC)Triple Negative Breast Cancer (TNBC)AB598AB122Zimberelimab

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary purpose of this study is to assess the safety and tolerability of AB598 in participants with advanced malignancies.

Official Title

A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants With Advanced Malignancies

Quick Facts

Study Start:2023-10-13
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05891171

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) guidance
  2. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  3. * 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.
  4. * Monotherapy-specific criteria for dose escalation and PD cohorts:
  5. * 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.
  6. * 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.
  7. * Dose Expansion cohort criteria:
  8. * Histologically confirmed, documented diagnosis of HER2-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.
  9. * No prior systemic treatment for locally advanced unresectable or metastatic disease.
  10. * Cannot have progressed within 6 months of prior platinum-based chemotherapy for earlier stage disease.
  1. * Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of study
  2. * Underlying medical conditions or AEs that, in the investigator or sponsor's opinion, will make the administration of the study drugs hazardous
  3. * 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
  4. * History of trauma or major surgery within 28 days prior to the first dose of study drug
  5. * 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

Contacts and Locations

Principal Investigator

Medical Director
STUDY_DIRECTOR
Arcus Biosciences

Study Locations (Sites)

Mayo Clinic Arizona
Phoenix, Arizona, 85054
United States
Mayo Clinic Florida
Jacksonville, Florida, 32224
United States
Lake City Cancer Care, LLC.
Lake City, Florida, 32024
United States
Affinity Health Hope and Healing Cancer Services, LLC
Hinsdale, Illinois, 60521
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Gabrail Cancer Center (GCC) Canton Facility
Canton, Ohio, 44718
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Next Oncology Dallas
Irving, Texas, 75039
United States
Next Oncology Virginia
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Arcus Biosciences, Inc.

  • Medical Director, STUDY_DIRECTOR, Arcus Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-13
Study Completion Date2026-03

Study Record Updates

Study Start Date2023-10-13
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • AB598
  • AB122
  • Zimberelimab

Additional Relevant MeSH Terms

  • 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)