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

Primary Purpose

Biliary Tract Carcinoma, Cholangiocarcinoma, Bile Duct Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine
Cisplatin
Zimberelimab
Quemliclustat
Sponsored by
Nataliya Uboha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. 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. 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. Exclusion Criteria: 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. Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational products.

Sites / Locations

  • University of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm A

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Estimate the overall survival (OS)
Overall survival, defined as the time from study enrollment to date of death due to any cause. Subjects without documented death at the time of analysis will be censored at the date of last known contact.
Estimate the objective response rate (ORR)
Objective response rate, defined as the proportion of subjects with a complete or partial response to treatment according to RECIST, version 1.1.
Estimate the disease control rate (DCR)
Disease control rate, defined as the proportion of subjects with stable disease, complete or partial response to treatment according to RECIST, version 1.1.
Estimate the duration of response (DOR)
Duration of Response (DOR) is defined as the time that measurement criteria are met for complete or partial response according to RECIST 1.1 (whichever status is recorded first) until the date recurrent or progressive disease, or death, is objectively documented (taking as reference for progressive disease the smallest measurements recorded since treatment started).
Evaluate safety of the proposed drug combination.
Safety and tolerability will be assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.

Full Information

First Posted
September 15, 2023
Last Updated
October 4, 2023
Sponsor
Nataliya Uboha
Collaborators
Arcus Biosciences, Inc., Gilead Sciences, University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT06048133
Brief Title
Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers
Official Title
Study of Gemcitabine, Cisplatin, Quemliclustat (AB680) and Zimberelimab (AB122) During First Line Treatment of Advanced Biliary Tract Cancers (BTC).
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nataliya Uboha
Collaborators
Arcus Biosciences, Inc., Gilead Sciences, University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Carcinoma, Cholangiocarcinoma, Bile Duct Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine IV: Day 1, 8, 22, and 29 every 42 days
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin IV: Day 1, 8, 22, and 29 every 42 days of Cycles 1-4 only.
Intervention Type
Drug
Intervention Name(s)
Zimberelimab
Other Intervention Name(s)
AB122
Intervention Description
Zimberelimab IV: Day 1 and 22 every 42 days
Intervention Type
Drug
Intervention Name(s)
Quemliclustat
Other Intervention Name(s)
AB680
Intervention Description
Quemliclustat IV: Day 1, 15, 29 every 42 days
Primary Outcome Measure Information:
Title
Estimate the progression free survival (PFS) with gemcitabine, cisplatin, quemliclustat (AB680) and zimberelimab (AB122) in patients with advanced BTCs.
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Estimate the overall survival (OS)
Description
Overall survival, defined as the time from study enrollment to date of death due to any cause. Subjects without documented death at the time of analysis will be censored at the date of last known contact.
Time Frame
2 years
Title
Estimate the objective response rate (ORR)
Description
Objective response rate, defined as the proportion of subjects with a complete or partial response to treatment according to RECIST, version 1.1.
Time Frame
2 years
Title
Estimate the disease control rate (DCR)
Description
Disease control rate, defined as the proportion of subjects with stable disease, complete or partial response to treatment according to RECIST, version 1.1.
Time Frame
2 years
Title
Estimate the duration of response (DOR)
Description
Duration of Response (DOR) is defined as the time that measurement criteria are met for complete or partial response according to RECIST 1.1 (whichever status is recorded first) until the date recurrent or progressive disease, or death, is objectively documented (taking as reference for progressive disease the smallest measurements recorded since treatment started).
Time Frame
2 years
Title
Evaluate safety of the proposed drug combination.
Description
Safety and tolerability will be assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. 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. Exclusion Criteria: 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. Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational products.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nataliya Uboha, MD, PhD
Phone
608-265-9966
Email
nvuboha@medicine.wisc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brittany Brugh
Phone
317-634-5842
Ext
13
Email
bbrugh@hoosiercancer.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nataliya Uboha, MD, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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