RECRUITING

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

Conditions

Biliary Tract Carcinoma Cholangiocarcinoma Bile Duct Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Study of Gemcitabine, Cisplatin, Quemliclustat (AB680) and Zimberelimab (AB122) During First-line Treatment of Advanced Biliary Tract Cancers (QUIC)

Quick Facts

Study Start:2024-03-08

Study Completion:2025-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06048133

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patients with cytologically or histologically confirmed BTC by AJCC version 8. 2. 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. 3. 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. 4. Age ≥ 18 years at the time of consent. 5. ECOG Performance Status of 0-2 within 28 days prior to registration. 6. Presence of measurable or evaluable disease, as defined by RECIST v1.1. 7. Adequate organ function as detailed in the protocol. 8. 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. 9. 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 120 days 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 120 days after the last dose of study drug(s). See the protocol for specific timeframes for each drug. 10. 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.	1. Prior therapy with gemcitabine, cisplatin, or any immune checkpoint inhibitors for the treatment of BTC. 2. Known hypersensitivity to recombinant proteins, or any excipient contained in treatment medication formulations. 3. 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. 4. History of solid organ or allogeneic bone marrow transplantation. 5. Pregnant or breastfeeding. NOTE: breast milk cannot be stored for future use while the mother is being treated on study. 6. 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. 7. Untreated central nervous system (CNS) metastasis. Screening of asymptomatic patients for CNS metastasis is not required for enrollment. 8. 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. 9. 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. 10. Treatment with palliative radiation therapy within 14 days of study treatment initiation. 11. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 12. Significant dementia or other mental condition that precludes the participant's ability to consent to the study. 13. Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational products.

Inclusion Criteria

Exclusion Criteria

1. Patients with cytologically or histologically confirmed BTC by AJCC version 8.
2. 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.
3. 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.
4. Age ≥ 18 years at the time of consent.
5. ECOG Performance Status of 0-2 within 28 days prior to registration.
6. Presence of measurable or evaluable disease, as defined by RECIST v1.1.
7. Adequate organ function as detailed in the protocol.
8. 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.
9. 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 120 days 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 120 days after the last dose of study drug(s). See the protocol for specific timeframes for each drug.
10. 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.

1. Prior therapy with gemcitabine, cisplatin, or any immune checkpoint inhibitors for the treatment of BTC.
2. Known hypersensitivity to recombinant proteins, or any excipient contained in treatment medication formulations.
3. 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.
4. History of solid organ or allogeneic bone marrow transplantation.
5. Pregnant or breastfeeding. NOTE: breast milk cannot be stored for future use while the mother is being treated on study.
6. 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.
7. Untreated central nervous system (CNS) metastasis. Screening of asymptomatic patients for CNS metastasis is not required for enrollment.
8. 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.
9. 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.
10. Treatment with palliative radiation therapy within 14 days of study treatment initiation.
11. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
12. Significant dementia or other mental condition that precludes the participant's ability to consent to the study.
13. Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational products.

Contacts and Locations

Study Contact

Nataliya Uboha, MD, PhD

CONTACT

608-265-9966

nvuboha@medicine.wisc.edu

Kimberly Cameron

CONTACT

317-634-5842

kcameron@hoosiercancer.org

Principal Investigator

Nataliya Uboha, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Study Locations (Sites)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202

United States

University of Michigan Health System

Ann Arbor, Michigan, 48109

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

United States

University of Wisconsin

Madison, Wisconsin, 53705

United States

Collaborators and Investigators

Sponsor: Nataliya Uboha

Nataliya Uboha, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-08

Study Completion Date2025-07

Study Record Updates

Study Start Date2024-03-08

Study Completion Date2025-07

Terms related to this study

Additional Relevant MeSH Terms

Biliary Tract Carcinoma
Cholangiocarcinoma
Bile Duct Cancer