NCT03545971 is a Phase 1 clinical trial of IBI310 in Advanced Solid Tumors, sponsored by Innovent Biologics (Suzhou) Co. Ltd..

Who is sponsoring NCT03545971?

NCT03545971 is sponsored by Innovent Biologics (Suzhou) Co. Ltd..

What drugs are being tested in NCT03545971?

Interventions in NCT03545971: IBI310, Sintilimab.

What condition does NCT03545971 study?

NCT03545971 studies Advanced Solid Tumors.

Is NCT03545971 still recruiting?

NCT03545971 is currently completed. Last updated 28 February 2023.

Last reviewed 2023-02-28 · How we verify

NCT03545971

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

A Study of IBI310 for the Treatment of Patients With Advanced Solid Tumors.

Completed Phase 1 Last updated 28 February 2023

What this trial tests

Phase 1 trial testing IBI310 in Advanced Solid Tumors in 53 participants. Completed in 9 August 2022.

Timeline

25 September 2018

Primary endpoint
10 September 2021

9 August 2022

Quick facts

Lead sponsor	Innovent Biologics (Suzhou) Co. Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	53
Start date	25 September 2018
Primary completion	10 September 2021
Estimated completion	9 August 2022
Sites	1 location across China

Drugs / interventions tested

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

Conditions studied

Advanced Solid Tumors — all drugs for Advanced Solid Tumors →

Sponsor

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

Who can join

Adults 18 to 70, any sex, with Advanced Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of single agent of IBI310, and in combination of sintilimab, in patients with advanced solid tumors(Ia) and advanced melanoma(Ib).

Publications & conference data

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

Influence of the Tumor Microenvironment on NK Cell Function in Solid Tumors.
Melaiu O, Lucarini V, Cifaldi L, Fruci D. · · 2019 · cited 324× · PMID 32038612 · DOI 10.3389/fimmu.2019.03038
Targeting NK Cell Checkpoint Receptors or Molecules for Cancer Immunotherapy.
Zhang C, Liu Y. · · 2020 · cited 75× · PMID 32714324 · DOI 10.3389/fimmu.2020.01295
IBI310 (anti-CTLA-4 antibody) monotherapy or in combination with sintilimab in advanced melanoma or urothelial carcinoma.
Cui C, Li J, Yang Y, Si L, et al · · 2024 · cited 2× · PMID 38881798 · DOI 10.1016/j.xinn.2024.100638

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
NCT05653180 — IBI310 in Combination With Sintilimab in Patients With Advanced Biliary Tract Cancer · Phase 1, PHASE2 · unknown
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

Other recruiting trials for Advanced Solid Tumors

Currently open trials in the same condition.

NCT07504445 — Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors · EARLY_PHASE1 · recruiting
NCT07589530 — Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07360314 — Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors · Phase 1 · recruiting
NCT07414316 — A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors. · EARLY_PHASE1 · recruiting
NCT07222969 — A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · 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 NCT03545971 (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: 28 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/NCT03545971.

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