NCT05110118 is a Phase 1 clinical trial of LY01008 in Metastatic Colorectal Cancer, sponsored by Shandong Boan Biotechnology Co., Ltd.

Who is sponsoring NCT05110118?

NCT05110118 is sponsored by Shandong Boan Biotechnology Co., Ltd.

What drugs are being tested in NCT05110118?

Interventions in NCT05110118: LY01008, Avastin.

What condition does NCT05110118 study?

NCT05110118 studies Metastatic Colorectal Cancer, Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Recurrent.

Is NCT05110118 still recruiting?

NCT05110118 is currently completed. Last updated 5 November 2021.

Last reviewed 2021-11-05 · How we verify

NCT05110118

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

Pharmacokinetic Characteristics, Safety, Tolerability and Immunogenicity of LY01008 and Avastin in Healthy Chinese Male Subjects

Completed Phase 1 Last updated 5 November 2021

What this trial tests

Phase 1 trial testing LY01008 in Metastatic Colorectal Cancer in 112 participants. Completed in 13 January 2021.

Timeline

4 August 2020

Primary endpoint
13 January 2021

13 January 2021

Quick facts

Lead sponsor	Shandong Boan Biotechnology Co., Ltd
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	112
Start date	4 August 2020
Primary completion	13 January 2021
Estimated completion	13 January 2021
Sites	1 location across China

Drugs / interventions tested

LY01008 — full drug profile →
Avastin — full drug profile →

Conditions studied

Metastatic Colorectal Cancer — all drugs for Metastatic Colorectal Cancer →
Non Small Cell Lung Cancer Metastatic — all drugs for Non Small Cell Lung Cancer Metastatic →
Non Small Cell Lung Cancer Recurrent — all drugs for Non Small Cell Lung Cancer Recurrent →

Sponsor

Shandong Boan Biotechnology Co., Ltd — full company profile →

Who can join

Adults 18 to 45, male only, with Metastatic Colorectal Cancer or Non Small Cell Lung Cancer Metastatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized, double-blind, single-dose, parallel-group study comparing pharmacokinetic characteristics, safety , tolerability and immunogenicity of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection) and Avastin (Bevacizumab Injection) in healthy Chinese male subjects.

Publications & conference data

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

Monoclonal antibody biosimilars for cancer treatment.
Broer LN, Knapen DG, de Groot DA, Mol PGM, et al · · 2024 · cited 4× · PMID 38974466 · DOI 10.1016/j.isci.2024.110115
A randomized, double-blind, parallel-group phase I study comparing the pharmacokinetics, safety, and immunogenicity of LY01008, a candidate bevacizumab biosimilar, with its reference product Avastin® in healthy Chinese male subjects.
Zhou R, Yang J, Liu Y, Zhang Q, et al · · 2022 · cited 2× · PMID 34913787 · DOI 10.1080/14712598.2022.2019703

Verify or expand the search:

Other trials of LY01008

Trials testing the same drug.

NCT03533127 — A Study of LY01008 and Bevacizumab Combined With Paclitaxel and Carboplatin for Treatment of Naïve Subjects With Metasta · Phase 3 · unknown

Other recruiting trials for Metastatic Colorectal Cancer

Currently open trials in the same condition.

NCT07416552 — A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC) · Phase 1 · recruiting
NCT07314294 — Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients · Phase 2 · recruiting
NCT06856837 — - IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Misma · Phase 2 · recruiting
NCT06959550 — Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorect · Phase 2 · recruiting
NCT06808685 — Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie · recruiting

Other Shandong Boan Biotechnology Co., Ltd trials

Trials by the same sponsor.

NCT06596915 — Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors · Phase 1 · recruiting
NCT06927349 — A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1301 in Advanced Solid Tumors. · Phase 1 · 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 NCT05110118 (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 Shandong Boan Biotechnology Co., Ltd
Last refreshed: 5 November 2021

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/NCT05110118.

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