Biliary Tract Neoplasms

Oncology
8
Pipeline Programs
4
Companies
15
Clinical Trials
1 recruiting
3
Approved Products

Pipeline by Development Stage

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

Drug Modality Breakdown

Small Molecule
375%
Monoclonal Antibody
125%
+ 1 programs with unclassified modality

On Market (3)

Approved therapies currently available

U
GEMCITABINEApproved
gemcitabine
Unknown Company
injection
AstraZeneca
IMFINZIApproved
durvalumab
AstraZeneca
Programmed Death Ligand-1 Blocker [EPC]injection2017
Taiho Oncology
LYTGOBIApproved
futibatinib
Taiho Oncology
oral2022

Competitive Landscape

4 companies ranked by most advanced pipeline stage

AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
2 programs
1
1
1
DurvalumabPhase 3Monoclonal Antibody1 trial
gemcitabinePhase 2/35 trials
Active Trials
NCT06109779Active Not Recruiting757Est. May 2030
NCT05212025Withdrawn0Est. Dec 2023
NCT03669601Unknown55Est. Sep 2024
+3 more trials
Taiho Oncology
Taiho OncologyNJ - Princeton
1 program
1
1
FutibatinibPhase 3Small Molecule1 trial
Active Trials
NCT05615818RecruitingEst. Jun 2028
Pierre Fabre
Pierre FabreFrance - Aignan
1 program
1
FutibatinibPhase 3Small Molecule
Zymeworks
ZymeworksMIDDLETOWN, DE
1 program
1
FutibatinibPhase 3Small Molecule

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
Taiho OncologyFutibatinib
AstraZenecagemcitabine
AstraZenecaDurvalumab
AstraZenecagemcitabine
AstraZenecagemcitabine
AstraZenecagemcitabine
AstraZenecagemcitabine
AstraZenecagemcitabine
AstraZenecagemcitabine
AstraZenecagemcitabine
AstraZenecagemcitabine
AstraZenecagemcitabine
AstraZenecagemcitabine
AstraZenecagemcitabine
AstraZenecagemcitabine

Clinical Trials (15)

Total enrollment: 2,261 patients across 15 trials

NCT05615818Taiho OncologyFutibatinib

Personalized Medicine for Advanced Biliary Cancer Patients

Start: Jul 2024Est. completion: Jun 2028
Phase 3Recruiting
NCT06109779AstraZenecagemcitabine

Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)

Start: Dec 2023Est. completion: May 2030757 patients
Phase 3Active Not Recruiting
NCT03875235AstraZenecaDurvalumab

Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)

Start: Apr 2019Est. completion: May 2027810 patients
Phase 3Active Not Recruiting
NCT00939848AstraZenecagemcitabine

Cediranib Versus Placebo Plus Cisplatin/Gemcitabine Chemotherapy for Patients With Advanced Biliary Tract Cancers

Start: Apr 2011Est. completion: Sep 2014124 patients
Phase 2/3Completed
NCT05212025AstraZenecagemcitabine

Adavosertib and Gemcitabine in Advanced Pancreatic

Start: Jun 2022Est. completion: Dec 20230
Phase 2Withdrawn
NCT01601808AstraZenecagemcitabine

Clinical Trial Comparing Gemcitabine and Vandetanib Therapy With Gemcitabine Alone in Pancreatic Carcinoma

Start: Oct 2011Est. completion: Sep 2018142 patients
Phase 2Completed
NCT00372944AstraZenecagemcitabine

AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy

Start: Aug 2006Est. completion: Oct 200870 patients
Phase 2Completed
NCT00265876AstraZenecagemcitabine

AZD0530 and Gemcitabine in Locally Advanced/Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

Start: Apr 2006Est. completion: Jan 201234 patients
Phase 1/2Completed
NCT03669601AstraZenecagemcitabine

AZD6738 & Gemcitabine as Combination Therapy

Start: Oct 2019Est. completion: Sep 202455 patients
Phase 1Unknown
NCT00937664AstraZenecagemcitabine

Safety and Tolerability Study of AZD7762 in Combination With Gemcitabine

Start: Jul 2009Est. completion: Feb 201124 patients
Phase 1Terminated
NCT00733031AstraZenecagemcitabine

Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD6918

Start: Aug 2008Est. completion: Mar 200975 patients
Phase 1Terminated
NCT00556023AstraZenecagemcitabine

A Phase 1 Study Testing CP-675,206 In Combination With Gemcitabine In Patients With Previously Untreated, Advanced Pancreatic Cancer

Start: Jun 2008Est. completion: Aug 201137 patients
Phase 1Completed
NCT00551096AstraZenecagemcitabine

Gemcitabine/Capecitabine/ZD6474 in Advanced Solid Tumors

Start: Oct 2007Est. completion: May 201323 patients
Phase 1Completed
NCT00515866AstraZenecagemcitabine

Study to Assess the Safety & Tolerability of a PARP Inhibitor in Combination With Gemcitabine in Pancreatic Cancer

Start: Aug 2007Est. completion: Jul 201268 patients
Phase 1Completed
NCT00413686AstraZenecagemcitabine

Study to Assess Safety of AZD7762 Administered Alone and in Combination With Gemcitabine in Patients With Advanced Solid Malignancies

Start: Dec 2006Est. completion: May 201042 patients
Phase 1Completed

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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

4 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 2,261 patients
Small Molecule is the dominant modality (75% of programs)
4 companies competing in this space

Related Indications

Breast Cancer(530)Non-small Cell Lung Cancer(373)Prostate Cancer(371)Multiple Myeloma(244)Advanced Solid Tumors(221)Acute Myeloid Leukemia(204)Cancer(187)Neoplasms(173)Colorectal Cancer(166)Advanced Solid Tumor(165)