Biliary Tract Cancer

Oncology
17
Pipeline Programs
16
Companies
16
Clinical Trials
3 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
4
9
2
1
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
457%
Monoclonal Antibody
343%
+ 12 programs with unclassified modality

Competitive Landscape

16 companies ranked by most advanced pipeline stage

Jazz Pharmaceuticals
Jazz PharmaceuticalsCA - Palo Alto
1 program
1
ZanidatamabPhase 3Monoclonal Antibody1 trial
Active Trials
NCT06282575Recruiting286Est. Apr 2030
H
HutchmedChina - Hong Kong
2 programs
1
1
SurufatinibPhase 2/3Small Molecule1 trial
SurufatinibPhase 2Small Molecule1 trial
Active Trials
NCT02966821Completed39Est. Nov 2018
NCT03873532Unknown298Est. Mar 2022
Compass Therapeutics
1 program
1
CTX-009Phase 2/31 trial
Active Trials
NCT05506943Active Not RecruitingEst. Dec 2025
Sanofi
SanofiPARIS, France
3 programs
3
BevacizumabPhase 2Monoclonal Antibody1 trial
CapecitabinePhase 2
ZD6474, VandetanibPhase 2Small Molecule1 trial
Active Trials
NCT00361231Completed35Est. Aug 2012
NCT00753675Completed174Est. Sep 2012
M&
Merck & Co.RAHWAY, NJ
1 program
1
Bintrafusp alfaPhase 21 trial
Active Trials
NCT04727541TerminatedEst. Jan 2022
Roche
RocheSTAVANGER NORWAY, Norway
1 program
1
CapecitabinePhase 21 trial
Active Trials
NCT00142480Completed8Est. Apr 2011
Alliance Pharmaceuticals
1 program
1
Irinotecan & CapecitabinePhase 21 trial
Active Trials
NCT02720601Withdrawn0Est. Mar 2020
E
EisaiChina - Liaoning
1 program
1
LenvatinibPhase 2Small Molecule1 trial
Active Trials
NCT02579616Completed29Est. Feb 2019
Xencor
XencorPASADENA, CA
1 program
1
XmAb20717Phase 21 trial
Active Trials
NCT05297903Active Not RecruitingEst. Dec 2026
Opko Health
Opko HealthMIAMI, FL
1 program
1
MDX2001Phase 1/21 trial
Active Trials
NCT06239194RecruitingEst. Feb 2029
ModeX Therapeutics
1 program
1
MDX2001Phase 1/2
Ipsen
IpsenChina - Tianjin
1 program
1
NivolumabPhase 1/2Monoclonal Antibody
CT
1 program
1
TQB2102 for injectionPhase 1/21 trial
Active Trials
NCT06431490RecruitingEst. Dec 2029
LP
Lee's PharmaceuticalChina - Guangzhou
1 program
1
ZKAB001 5mg/kgPhase 11 trial
Active Trials
NCT04608786Unknown10Est. Dec 2023
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
1 program
Imfinzi BTC Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - CEI/SCEIN/A1 trial
Active Trials
NCT05835778Completed236Est. Nov 2025
Precision BioSciences
1 program
Multi-Platform Profiling with Organoid Drug Sensitivity Screening and ctDNA MonitoringN/A1 trial
Active Trials
NCT04561453Terminated14Est. Apr 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
Jazz PharmaceuticalsZanidatamab
Compass TherapeuticsCTX-009
HutchmedSurufatinib
XencorXmAb20717
Merck & Co.Bintrafusp alfa
HutchmedSurufatinib
Alliance PharmaceuticalsIrinotecan & Capecitabine
EisaiLenvatinib
SanofiZD6474, Vandetanib
SanofiBevacizumab
RocheCapecitabine
Chia Tai TianQing Pharmaceutical GroupTQB2102 for injection
Opko HealthMDX2001
Lee's PharmaceuticalZKAB001 5mg/kg
AstraZenecaImfinzi BTC Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - CEI/SCEI

Showing 15 of 16 trials with date data

Clinical Trials (16)

Total enrollment: 1,129 patients across 16 trials

NCT06282575Jazz PharmaceuticalsZanidatamab

Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer

Start: Jul 2024Est. completion: Apr 2030286 patients
Phase 3Recruiting
NCT05506943Compass TherapeuticsCTX-009

A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)

Start: Jan 2023Est. completion: Dec 2025
Phase 2/3Active Not Recruiting
NCT03873532HutchmedSurufatinib

A Trial Evaluating Surufatinib Efficacy and Safety in Biliary Tract Carcinoma Patients

Start: Jul 2018Est. completion: Mar 2022298 patients
Phase 2/3Unknown
NCT05297903XencorXmAb20717

XmAb20717 in Advanced Biliary Tract Cancers

Start: Apr 2022Est. completion: Dec 2026
Phase 2Active Not Recruiting
NCT04727541Merck & Co.Bintrafusp alfa

Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer

Start: Jul 2021Est. completion: Jan 2022
Phase 2Terminated
NCT02966821HutchmedSurufatinib

Study of Surufatinib as Second-line Treatment in Patients With Biliary Tract Carcinoma

Start: Jan 2017Est. completion: Nov 201839 patients
Phase 2Completed
NCT02720601Alliance PharmaceuticalsIrinotecan & Capecitabine

Irinotecan and Capecitabine as Second-line Treatment for Advanced/Metastatic Biliary Tract Cancers

Start: Nov 2015Est. completion: Mar 20200
Phase 2Withdrawn
NCT02579616EisaiLenvatinib

Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer (BTC) Who Failed Gemcitabine-based Combination Chemotherapy

Start: Oct 2015Est. completion: Feb 201929 patients
Phase 2Completed
NCT00753675SanofiZD6474, Vandetanib

Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer

Start: Oct 2008Est. completion: Sep 2012174 patients
Phase 2Completed
NCT00361231SanofiBevacizumab

Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Biliary Tract and Gallbladder Cancer

Start: May 2006Est. completion: Aug 201235 patients
Phase 2Completed
NCT00142480RocheCapecitabine

Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Patients With Biliary Tract and Gallbladder Cancer

Start: Dec 2004Est. completion: Apr 20118 patients
Phase 2Completed
NCT06431490Chia Tai TianQing Pharmaceutical GroupTQB2102 for injection

A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer

Start: Jul 2024Est. completion: Dec 2029
Phase 1/2Recruiting
NCT06239194Opko HealthMDX2001

Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors

Start: Jun 2024Est. completion: Feb 2029
Phase 1/2Recruiting
NCT04608786Lee's PharmaceuticalZKAB001 5mg/kg

A Clinical Study of PD-L1 Antibody ZKAB001 Combined With Capecitabine in Resected Biliary Tract Cancer

Start: Feb 2021Est. completion: Dec 202310 patients
Phase 1Unknown
NCT05835778AstraZenecaImfinzi BTC Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - CEI/SCEI

Imfinzi BTC Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - CEI/SCEI

Start: Jun 2023Est. completion: Nov 2025236 patients
N/ACompleted
NCT04561453Precision BioSciencesMulti-Platform Profiling with Organoid Drug Sensitivity Screening and ctDNA Monitoring

Feasibility Study of Multi-Platform Profiling of Resected Biliary Tract Cancer

Start: Jul 2020Est. completion: Apr 202514 patients
N/ATerminated

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

1 late-stage (Phase 3) programs — potential near-term approvals
3 actively recruiting trials targeting 1,129 patients
16 companies competing in this space

Related Indications

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