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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Nataliya Uboha
Study ID
NCT06048133
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Bile Duct Cancer
  • Biliary Tract Carcinoma
  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    Gemcitabine IV: Day 1, 8, 22, and 29 every 42 days
  • Cisplatin — DRUG
    Cisplatin IV: Day 1, 8, 22, and 29 every 42 days of Cycles 1-4 only.
  • Zimberelimab — DRUG
    Zimberelimab IV: Day 1 and 22 every 42 days
  • Quemliclustat — DRUG
    Quemliclustat IV: Day 1, 15, 29 every 42 days

Study Details

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.

Key Dates

Start date
Mar 8, 2024
Status verified
Jan 2026
Primary completion
Jan 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    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.

Primary Outcome Measure

Estimate the progression free survival (PFS) with gemcitabine, cisplatin, quemliclustat (AB680) and zimberelimab (AB122) in patients with advanced BTCs. [ Time Frame: 2 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202
Aaron Spittler
[email protected]
Anita Turk, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan Health SystemAnn ArborMichigan48109
Madelyn Walker
[email protected]
Vaibhav Sahai, MD (PRINCIPAL_INVESTIGATOR)
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903
Nicole Gonzalez
[email protected]
Howard Hochster, MD (PRINCIPAL_INVESTIGATOR)
University of WisconsinMadisonWisconsin53705
UWCCC Cancer Connect
[email protected]
800-622-8922
Nataliya V Uboha, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Indianapolis, IN

By research site
Indiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, INUniversity of Michigan Health System· Ann Arbor, MIRutgers Cancer Institute of New Jersey· New Brunswick, NJUniversity of Wisconsin· Madison, WI

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