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Active, not recruiting Phase 1

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

NCT05891171 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2023-10-13
Last updated
2026-09-29

Condition(s) studied

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)

Investigational drug(s) / intervention(s)

AB598Zimberelimab →Fluorouracil →Leucovorin →Oxaliplatin →

AB598: Administered as specified in the treatment arm

Zimberelimab: Administered as specified in the treatment arm

Fluorouracil: Administered as specified in the treatment arm

Leucovorin: Administered as specified in the treatment arm

Oxaliplatin: Administered as specified in the treatment arm

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — Up to 2 years
  • Dose Escalation Cohorts: Number of Participants with Dose-Limiting Toxicities (DLTs) — Up to 2 years

Trial sites (14)

FacilityCityRegionStatus
Research Site Phoenix Arizona
Research Site Jacksonville Florida
Research Site Lake City Florida
Research Site Hinsdale Illinois
Research Site Detroit Michigan
Research Site Rochester Minnesota
Research Site New Brunswick New Jersey
Research Site Canton Ohio
Research Site Cleveland Ohio
Research Site Irving Texas
Research Site Fairfax Virginia
Research Site Adelaide Australia
Research Site Tainan Taiwan
Research Site Taipei Taiwan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05891171 on ClinicalTrials.gov ↗ ← All trials in the USA