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Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC)

NCT06048133 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-01-23

No results posted yet for this study

Summary

This is a phase 2 study of gemcitabine, cisplatin, zimberelimab (AB122) and quemliclustat (AB680) in subjects with untreated advanced biliary tract cancers (BTC). The study will include a safety run-in involving 6 study participants. The goal of the safety run-in is to screen for early safety signals of the proposed drug combination. Trial enrollment can continue while full safety assessment is being completed for the first 6 subjects.

Participants will receive 4 cycles of combination therapy as described. After 4 cycles (\~6 months), cisplatin will be discontinued, while gemcitabine, zimberelimab (AB122), and quemliclustat (AB680) will be continued. Subjects will be treated until disease progression or development of intolerable toxicities. In total, there will be up to 39 participants on the study.

Conditions

Interventions

DRUG

Gemcitabine

Gemcitabine IV: Day 1, 8, 22, and 29 every 42 days

DRUG

Cisplatin

Cisplatin IV: Day 1, 8, 22, and 29 every 42 days of Cycles 1-4 only.

DRUG

Zimberelimab

Zimberelimab IV: Day 1 and 22 every 42 days

DRUG

Quemliclustat

Quemliclustat IV: Day 1, 15, 29 every 42 days

Sponsors & Collaborators

  • Arcus Biosciences, Inc.

    collaborator INDUSTRY

  • Gilead Sciences

    collaborator INDUSTRY

  • University of Wisconsin, Madison

    collaborator OTHER

  • Nataliya Uboha

    lead OTHER

Principal Investigators

  • Nataliya Uboha, MD, PhD · University of Wisconsin, Madison

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-08
Primary Completion
2026-01-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06048133 on ClinicalTrials.gov