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RECRUITING Phase 2

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

NCT06048133 · View on ClinicalTrials.gov ↗

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.

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

32 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nataliya Uboha, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06048133 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Indiana, Michigan, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06048133?

The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), Zimberelimab (DRUG), Quemliclustat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06048133?

This trial is sponsored by Nataliya Uboha, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial