NCT05653180 is a Phase 1, PHASE2 clinical trial of IBI310 in Advanced Biliary Tract Cancer, sponsored by Innovent Biologics (Suzhou) Co. Ltd..

Who is sponsoring NCT05653180?

NCT05653180 is sponsored by Innovent Biologics (Suzhou) Co. Ltd..

What drugs are being tested in NCT05653180?

Interventions in NCT05653180: IBI310, sintilimab.

What condition does NCT05653180 study?

NCT05653180 studies Advanced Biliary Tract Cancer.

Is NCT05653180 still recruiting?

NCT05653180 is currently status unknown. Last updated 3 April 2023.

Last reviewed 2023-04-03 · How we verify

NCT05653180

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

IBI310 in Combination With Sintilimab in Patients With Advanced Biliary Tract Cancer

Status unknown Phase 1, PHASE2 Last updated 3 April 2023

What this trial tests

Phase 1, PHASE2 trial testing IBI310 in Advanced Biliary Tract Cancer in 20 participants. Status unknown.

Timeline

10 March 2023

Primary endpoint
31 December 2023

1 June 2024

Quick facts

Lead sponsor	Innovent Biologics (Suzhou) Co. Ltd.
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	10 March 2023
Primary completion	31 December 2023
Estimated completion	1 June 2024
Sites	1 location across China

Drugs / interventions tested

IBI310 — full drug profile →
sintilimab — full drug profile →

Conditions studied

Advanced Biliary Tract Cancer — all drugs for Advanced Biliary Tract Cancer →

Sponsor

Innovent Biologics (Suzhou) Co. Ltd. — full company profile →

Who can join

18 and older, any sex, with Advanced Biliary Tract Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This research study is designed to establish whether the combination of IBI310 \& Sintilimab has efficacy in patients with advanced BTC

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Recent Advances in Immunotherapy for Advanced Biliary Tract Cancer.
Yue S, Zhang Y, Zhang W. · · 2024 · cited 11× · PMID 39066855 · DOI 10.1007/s11864-024-01243-y

Verify or expand the search:

Other trials of IBI310

Trials testing the same drug.

NCT07490262 — A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular · Phase 2, PHASE3 · recruiting
NCT05118334 — IBI310 (Anti-CTLA-4) in Combination With Sintilimab in Patients With Non-small-cell Lung Cancer (NSCLC) · Phase 1 · completed
NCT04945421 — IBI310 in Combination With Siltilimab in Subjects With Anti-PD-1/PD-L1 Resistance R/M NPC · Phase 1 · completed
NCT04868760 — A Study to Evaluate the Similarity in Pharmacokinetics and Safety of IBI310 and Ipilimumab（YERVOY）in Adult Healthy Chine · Phase 1 · completed
NCT04720716 — A Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Tr · Phase 3 · completed

Other recruiting trials for Advanced Biliary Tract Cancer

Currently open trials in the same condition.

NCT06988592 — GemCis Plus PD-1/PD-L1 Inhibitor in Advanced Biliary Tract Cancer: Efficacy and Immune Microenvironment （BTC-IM-1） · recruiting
NCT04969887 — Combination Immunotherapy in Rare Cancers Under InvesTigation · Phase 2 · active not recruiting
NCT04727996 — Phase II Study of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Biliary Tract Cancer · Phase 2 · active not recruiting
NCT04005339 — NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer · Phase 2 · active not recruiting

Other Innovent Biologics (Suzhou) Co. Ltd. trials

Trials by the same sponsor.

NCT07502534 — A Clinical Study Comparing the Bioequivalence of IBI3027 and DUPIXENT®(Dupilumab) in Healthy Chinese Volunteers · Phase 1 · not yet recruiting
NCT07469800 — Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight/Obesity · Phase 3 · not yet recruiting
NCT07473960 — IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia · Phase 3 · recruiting
NCT07483567 — IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastri · Phase 2 · not yet recruiting
NCT07483554 — IBI343 in Combination Therapy for Advanced Malignant Solid Tumors · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05653180 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Innovent Biologics (Suzhou) Co. Ltd.
Last refreshed: 3 April 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05653180.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing