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

Status: Active_not_recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
Mayo Clinic Arizona
Phoenix
Florida
Mayo Clinic Florida
Jacksonville
Lake City Cancer Care, LLC.
Lake City
Illinois
Affinity Health Hope and Healing Cancer Services, LLC
Hinsdale
Michigan
Karmanos Cancer Institute
Detroit
Minnesota
Mayo Clinic Rochester
Rochester
New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick
Ohio
Gabrail Cancer Center (GCC) Canton Facility
Canton
University Hospitals Cleveland Medical Center
Cleveland
Texas
Next Oncology Dallas
Irving
Virginia
Next Oncology Virginia
Fairfax
Other Locations
Australia
Adelaide Cancer Research
Adelaide
Queen Elizabeth Hospital
Adelaide
Taiwan
National Cheng Kung University Hospital
Tainan
Taipei Veterans General Hospital
Taipei
Time Frame
Start Date: 2023-10-13
Completion Date: 2026-03
Participants
Target number of participants: 40
Treatments
Experimental: Dose Escalation Cohort 1
Participants will receive AB598 intravenous (IV) infusion once every 3 weeks
Experimental: Dose Escalation Cohort 2
Participants will receive AB598 IV infusion once every 3 weeks
Experimental: Dose Escalation Cohort 3
Participants will receive AB598 IV infusion once every 3 weeks
Experimental: Dose Escalation Cohort 4
Participants will receive AB598 IV infusion once every 3 weeks
Experimental: Pharmacodynamic Cohort 1
Participants will receive AB598 IV infusion once every 3 weeks
Experimental: Pharmacodynamic Cohort 2
Participants will receive AB598 IV infusion once every 3 weeks
Experimental: Pharmacodynamic Cohort 3
Participants will receive AB598 IV infusion once every 3 weeks
Experimental: Dose Expansion Gastric/GEJ Cancer (phase 1b)
Participants will receive AB598 IV infusion every 2 weeks in combination with zimberelimab and FOLFOX (oxaliplatin, leucovorin, fluorouracil)
Sponsors
Leads: Arcus Biosciences, Inc.

This content was sourced from clinicaltrials.gov