NCT04945421 is a Phase 1 clinical trial of Sintilimab in NPC, sponsored by Innovent Biologics (Suzhou) Co. Ltd..

Who is sponsoring NCT04945421?

NCT04945421 is sponsored by Innovent Biologics (Suzhou) Co. Ltd..

What drugs are being tested in NCT04945421?

Interventions in NCT04945421: Sintilimab, IBI310.

Is NCT04945421 still recruiting?

NCT04945421 is currently completed. Last updated 23 February 2023.

Last reviewed 2023-02-23 · How we verify

NCT04945421

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

IBI310 in Combination With Siltilimab in Subjects With Anti-PD-1/PD-L1 Resistance R/M NPC

Completed Phase 1 Last updated 23 February 2023

What this trial tests

Phase 1 trial testing Sintilimab in NPC in 30 participants. Completed in 6 February 2023.

Timeline

23 July 2021

Primary endpoint
25 April 2022

6 February 2023

Quick facts

Lead sponsor	Innovent Biologics (Suzhou) Co. Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	23 July 2021
Primary completion	25 April 2022
Estimated completion	6 February 2023
Sites	1 location across China

Drugs / interventions tested

Sintilimab — full drug profile →
IBI310 — full drug profile →

Conditions studied

NPC — all drugs for NPC →

Sponsor

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

Who can join

18 and older, any sex, with NPC. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase 1b/II, open label, multicenter study of IBI310 (Anti-CTLA4 mAb) in combination with Sintilimab in patients with recurrent/metastatic Nasopharyngeal Carcinoma that failed prior Anti-PD-1/PD-L1 therapy

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Nasopharyngeal carcinoma: current views on the tumor microenvironment's impact on drug resistance and clinical outcomes.
Liu H, Tang L, Li Y, Xie W, et al · · 2024 · cited 85× · PMID 38254110 · DOI 10.1186/s12943-023-01928-2
Immunotherapy for nasopharyngeal carcinoma: Current status and prospects (Review).
Huang H, Yao Y, Deng X, Huang Z, et al · · 2023 · cited 78× · PMID 37417358 · DOI 10.3892/ijo.2023.5545
Current status and advances of immunotherapy in nasopharyngeal carcinoma.
Xu JY, Wei XL, Wang YQ, Wang FH. · · 2022 · cited 62× · PMID 35547095 · DOI 10.1177/17588359221096214
Current Status in Rechallenge of Immunotherapy.
Hu H, Wang K, Jia R, Zeng ZX, et al · · 2023 · cited 35× · PMID 37215995 · DOI 10.7150/ijbs.82776
Nasopharyngeal Carcinoma and Its Microenvironment: Past, Current, and Future Perspectives.
Su ZY, Siak PY, Leong CO, Cheah SC. · · 2022 · cited 32× · PMID 35311066 · DOI 10.3389/fonc.2022.840467
Revealing the crosstalk between nasopharyngeal carcinoma and immune cells in the tumor microenvironment.
Jiang J, Ying H. · · 2022 · cited 29× · PMID 35964134 · DOI 10.1186/s13046-022-02457-4
Novel Therapeutic Development for Nasopharyngeal Carcinoma.
Kim J, Lee Y, Kim S, Park JC. · · 2025 · PMID 41002550 · DOI 10.3390/curroncol32090479

Verify or expand the search:

Other trials of Sintilimab

Trials testing the same drug.

NCT07535632 — SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cance · Phase 2 · not yet recruiting
NCT07537946 — Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer · Phase 3 · not yet recruiting
NCT07537972 — Denosumab Strategy for Liver Cancer With Bone Metastases · Phase 2 · not yet recruiting
NCT07468630 — Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma · Phase 2 · recruiting
NCT07515625 — Efficacy of Sintilimab Combined With Bevacizumab and XELOX/SOX in Initially Unresectable AFP-positive Gastric/Gastroesop · Phase 2 · not yet recruiting

Other recruiting trials for NPC

Currently open trials in the same condition.

NCT03734809 — NEO-SPACE Trial: Pembrolizumab and Chemoradiation in Nasopharyngeal Cancer · Phase 2 · active not recruiting
NCT03919552 — Cisplatin-based and Carboplatin-based Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma · Phase 3 · 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 NCT04945421 (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: 23 February 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/NCT04945421.

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