NCT04104672

A Study to Evaluate the Safety and Tolerability of AB680 in Participants With Gastrointestinal Malignancies

A Phase 1 Study to Evaluate the Safety and Tolerability of AB680 Combination Therapy in Participants With Gastrointestinal Malignancies

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Arcus Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, dose-escalation, and dose-expansion, with a gated randomization portion, study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic and clinical activity of AB680 in combination with zimberelimab (AB122), nab-paclitaxel and gemcitabine in participants with advanced pancreatic cancer.

Detailed description

Dose escalation of AB680 in combination with zimberelimab (AB122), nab-paclitaxel and gemcitabine will be assessed in participants with advanced pancreatic cancer. In this dose escalation combination study, participants with advanced pancreatic cancer will receive escalating doses of AB680 in combination with zimberelimab at the recommended phase 2 dose (RP2D), and nab-paclitaxel and gemcitabine at standard doses. AB680, zimberelimab, nab-paclitaxel and gemcitabine are all administered via IV infusion. In the dose expansion portion of the study in front-line (1L) pancreatic patients, participants will receive AB680 at the RP2D determined from the dose escalation study in combination with zimberelimab at the RP2D and nab-paclitaxel and gemcitabine at standard doses or AB680 at the RP2D in combination with nab-paclitaxel and gemcitabine at standard doses. In the dose-expansion portion of the study in second-line (2L) pancreatic patients, participants will receive AB680 at the RP2D determined from the dose-escalation study in combination with zimberelimab at the RP2D and nab-paclitaxel and gemcitabine at standard doses.

Conditions

• Advanced Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	AB680	AB680 is a Cluster of Differentiation (CD)73 Inhibitor.
DRUG	Zimberelimab	Zimberelimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1.
DRUG	Nab-paclitaxel	Nab-paclitaxel is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
DRUG	Gemcitabine	Gemcitabine is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.

Timeline

• Start date: 2019-11-06
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2019-09-26
• Last updated: 2026-03-31

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study