← Back to Search

Platinum-based agents

Drug Combination for Biliary Tract Cancer

Phase 2

Recruiting

Led By Nataliya Uboha, MD, PhD

Research Sponsored by Nataliya Uboha

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years at the time of consent

Patients must have late stage (locally advanced, recurrent or metastatic) BTC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial studies a combination of 4 drugs to treat people with advanced biliary tract cancer who have not yet been treated. Up to 39 people will be enrolled and monitored for safety.

Who is the study for?

Adults with advanced biliary tract cancers who haven't had systemic treatment for it can join. They must have measurable disease, good organ function, and no recent major surgeries or untreated brain metastasis. Participants need to be able to follow the study plan and use effective birth control if they can have children.Check my eligibility

What is being tested?

The trial is testing a combination of gemcitabine, cisplatin, zimberelimab (AB122), and quemliclustat (AB680) in patients with advanced biliary tract cancers. It starts with a safety check on the first 6 people before continuing up to 39 participants who will receive these drugs until their disease worsens or side effects become too much.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system affecting organs, fatigue, nausea from chemotherapy drugs like gemcitabine and cisplatin, as well as potential risks associated with new treatments such as zimberelimab and quemliclustat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

My bile duct cancer is in a late stage.

Select...

My bile duct cancer is confirmed by a specific test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Estimate the progression free survival (PFS) with gemcitabine, cisplatin, quemliclustat (AB680) and zimberelimab (AB122) in patients with advanced BTCs.

Secondary outcome measures

Estimate the disease control rate (DCR)

Estimate the duration of response (DOR)

Estimate the objective response rate (ORR)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm AExperimental Treatment4 Interventions

Quemliclustat (AB680), zimberelimab (AB122), gemcitabine, and cisplatin in subjects with untreated advanced BTC. Quemliclustat IV: Day 1, 15, and 29 of each cycle; Zimberelimab IV: Day 1 and 22 of each cycle; Gemcitabine IV: Day 1, 8, 22 and 29 of each cycle; Cisplatin IV: Day 1, 8, 22 and 29 of Cycles 1-4 only.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zimberelimab

2018

Completed Phase 1

~50

Gemcitabine

2017

Completed Phase 3

~2070

Cisplatin

2013

Completed Phase 3

~1940

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nataliya UbohaLead Sponsor

1 Previous Clinical Trials

3 Total Patients Enrolled

Arcus Biosciences, Inc.Industry Sponsor

41 Previous Clinical Trials

6,027 Total Patients Enrolled

Gilead SciencesIndustry Sponsor

1,084 Previous Clinical Trials

848,223 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for this research project?

"According to clinicaltrials.gov, the initial posting of this medical trial was on September 1st 2023 and it has not been updated since 15th September 2023; therefore, patients are not being sought for enrollment at present. However, there 306 other studies that are actively recruiting candidates."

Answered by AI

To what degree is Arm A safe for participants?

"Arm A's safety is rated a 2 on the scale of 1 to 3, due to being a Phase 2 trial with initial data regarding its security but no evidence for efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Nataliya Uboha 2024. "Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06048133.

All > Intrahepatic Cholangiocarcinoma > Bile Duct Cancer