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

Description

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

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)

Study Overview

Study Details

Study overview

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

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

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

Condition
Advanced Cancer
Intervention / Treatment

-

Contacts and Locations

Phoenix

Mayo Clinic Arizona, Phoenix, Arizona, United States, 85054

Santa Monica

Ronald Reagan UCLA Medical Center, Santa Monica, California, United States, 90095

Santa Rosa

Providence Medical Group Santa Rosa - Cancer Center, Santa Rosa, California, United States, 95403

Jacksonville

Mayo Clinic Florida, Jacksonville, Florida, United States, 32224

Lake City

Lake City Cancer Care, LLC., Lake City, Florida, United States, 32024

Hinsdale

Affinity Health Hope and Healing Cancer Services, LLC, Hinsdale, Illinois, United States, 60521

Goshen

Goshen Center for Cancer Care, Goshen, Indiana, United States, 46526

Detroit

Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

Rochester

Mayo Clinic Rochester, Rochester, Minnesota, United States, 55905

New Brunswick

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States, 08901

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Arcus Biosciences, Inc.,

Medical Director, STUDY_DIRECTOR, Arcus Biosciences

Study Record Dates

2026-03