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NCT06048133 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Cholangiocarcinoma and Bile Duct Cancer, sponsored by Nataliya Uboha.

Recruiting
Registry status
Phase 2
Development phase
33
Enrollment target
4
Study locations

NCT06048133 is a Phase 2 study of Cholangiocarcinoma and Bile Duct Cancer that is actively recruiting participants, run by Nataliya Uboha. The registered enrollment target is 33 participants, below the 385-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (91% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT06048133, a Phase 2 study of Cholangiocarcinoma and Bile Duct Cancer, is actively recruiting participants, sponsored by Nataliya Uboha.

RECRUITING
Registry status
Phase 2
Development phase
33 participants
Enrollment target
4
Study locations

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 Studied

Cholangiocarcinoma Bile Duct Cancer Biliary Tract Carcinoma

Interventions

  • DRUG Cisplatin
  • DRUG Gemcitabine
  • DRUG Zimberelimab
  • DRUG Quemliclustat

Study Locations (4)

Indiana

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center - Indianapolis

Michigan

  • University of Michigan Health System - Ann Arbor

New Jersey

  • Rutgers Cancer Institute of New Jersey - New Brunswick

Wisconsin

  • University of Wisconsin - Madison

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2024-03-08
Est. Completion 2027-07
Phase Phase 2

Sponsor

Nataliya Uboha

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06048133

The ClinicalTrials.gov registry entry for NCT06048133 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 385-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (91% lower). The listed sponsor is Nataliya Uboha, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Cholangiocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Cisplatin is the first listed.

NCT06048133 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Indiana, Michigan, New Jersey.

Frequently Asked Questions

What is clinical trial NCT06048133 about?

NCT06048133 is a clinical study titled "Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC)". 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 signal...

What is the current status of trial NCT06048133?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2024-03-08. Estimated completion is 2027-07.

What conditions does trial NCT06048133 study?

This clinical trial studies the following conditions: Cholangiocarcinoma, Bile Duct Cancer, Biliary Tract Carcinoma.

What interventions are being tested in trial NCT06048133?

The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), Zimberelimab (DRUG), Quemliclustat (DRUG).

Who is sponsoring clinical trial NCT06048133?

This trial is sponsored by Nataliya Uboha, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06048133 being conducted?

This trial has 4 study locations across Indiana, Michigan, New Jersey, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.