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

NCT06048133 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: BTCRC-GI22-564
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 4

Brief 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

Biliary Tract Carcinoma; Cholangiocarcinoma; Bile Duct Cancer

Outcome Measures

Primary Outcomes (1)

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

  Progression free survival (PFS), as determined by RECIST v1.1, is defined as the time from study registration to the date of documented disease progression or death from any cause.

  2 years

Secondary Outcomes (5)

• Estimate the overall survival (OS)

  2 years

• Estimate the objective response rate (ORR)

  2 years

• Estimate the disease control rate (DCR)

  2 years

• Estimate the duration of response (DOR)

  2 years

• Evaluate safety of the proposed drug combination.

  2 years

Study Arms (1)

Arm A

EXPERIMENTAL

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.

Drug: Gemcitabine; Drug: Cisplatin; Drug: Zimberelimab; Drug: Quemliclustat

Interventions

Gemcitabine DRUG

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

Arm A

Cisplatin DRUG

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

Arm A

Zimberelimab DRUG

Zimberelimab IV: Day 1 and 22 every 42 days

Also known as: AB122

Arm A

Quemliclustat DRUG

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

Also known as: AB680

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with cytologically or histologically confirmed BTC by AJCC version 8.
• Patients must have late stage (locally advanced, recurrent or metastatic) BTC. Patients must not have received systemic treatment for advanced disease. Prior adjuvant therapy is allowed as long as recurrences occurred 6 months or later from all treatment completion.
• Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
• Age ≥ 18 years at the time of consent.
• ECOG Performance Status of 0-2 within 28 days prior to registration.
• Presence of measurable or evaluable disease, as defined by RECIST v1.1.
• Adequate organ function as detailed in the protocol.
• Females of childbearing potential who are sexually active with a male able to father a child must have a negative pregnancy test (serum or urine) within 14 days prior to registration. NOTE: Biliary cancer may secrete hormones to produce a false-positive pregnancy test. Female subjects of childbearing potential with a positive pregnancy test should have a thorough history and additional work up as determined by the treating physician to rule out pregnancy (e.g. serial βHCG measurements, ultrasound). Once pregnancy has been ruled out, the subject may proceed with screening and enrollment.
• Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from heterosexual vaginal intercourse or use an effective method(s) of contraception from the time of informed consent, during the study and for up to 14 months after the last dose of study drug(s). Males able to father a child must be willing to abstain from heterosexual vaginal intercourse or to use an effective method(s) of contraception from initiation of treatment, during the study and for up to 11 months after the last dose of study drug(s). See the protocol for specific timeframes for each drug.
• Ability of the subject to understand and comply with study procedures for the entire length of the study, as determined by the enrolling physician or protocol designee.

You may not qualify if:

• Prior therapy with gemcitabine, cisplatin, or any immune checkpoint inhibitors for the treatment of BTC.
• Known hypersensitivity to recombinant proteins, or any excipient contained in treatment medication formulations.
• Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• NOTE: participants with asthma who require intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections will not be excluded from this study.
• History of solid organ or allogeneic bone marrow transplantation.
• Pregnant or breastfeeding. NOTE: breast milk cannot be stored for future use while the mother is being treated on study.
• Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial.
• Untreated central nervous system (CNS) metastasis. Screening of asymptomatic patients for CNS metastasis is not required for enrollment.
• Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of IP(s) hazardous, including but not limited to
• Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis.
• Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of the study treatments.
• History of trauma or major surgery within 28 days prior to the first dose of IP. (Note that placement of central venous access catheter (e.g., port or similar) is not considered a major surgical procedure.
• Treatment with palliative radiation therapy within 14 days of study treatment initiation.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Significant dementia or other mental condition that precludes the participant's ability to consent to the study.

Sponsors & Collaborators

• Nataliya Uboha: lead
• Arcus Biosciences, Inc.: collaborator
• Gilead Sciences: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (4)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

RECRUITING

University of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma; Bile Duct Neoplasms

Interventions

Gemcitabine; Cisplatin; zimberelimab; quemliclustat

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Nataliya Uboha, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nataliya Uboha, MD, PhD

CONTACT

608-265-9966; nvuboha@medicine.wisc.edu

LeaEtta Hyer

CONTACT

317-634-5842; lhyer@hoosiercancer.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 21, 2023
• Study Start: March 8, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (4)