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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

Must not have

Prior therapy with gemcitabine, cisplatin, or any immune checkpoint inhibitors for the treatment of BTC

History of solid organ or allogeneic bone marrow transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I am 18 years old or older.

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My bile duct cancer is in a late stage.

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My bile duct cancer is confirmed by a specific test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with gemcitabine, cisplatin, or immune checkpoint inhibitors for bile duct cancer.

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I have had a solid organ or bone marrow transplant.

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I do not have another cancer that could affect this trial's safety or results.

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I have brain metastases that have not been treated.

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I have received palliative radiation therapy within the last 14 days.

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I do not have dementia or any mental condition that affects my ability to consent.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Estimate the disease control rate (DCR)

Estimate the duration of response (DOR)

Estimate the objective response rate (ORR)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Gemcitabine

2017

Completed Phase 3

~1920

Cisplatin

2013

Completed Phase 3

~3120