NCT05323045 is a Phase 1 clinical trial of BYON3521 in Solid Tumor, sponsored by Byondis B.V..

Who is sponsoring NCT05323045?

NCT05323045 is sponsored by Byondis B.V..

What drugs are being tested in NCT05323045?

Interventions in NCT05323045: BYON3521.

What condition does NCT05323045 study?

NCT05323045 studies Solid Tumor.

Is NCT05323045 still recruiting?

NCT05323045 is currently completed. Last updated 9 July 2025.

Last reviewed 2025-07-09 · How we verify

NCT05323045

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

A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate BYON3521

Completed Phase 1 Last updated 9 July 2025

What this trial tests

Phase 1 trial testing BYON3521 in Solid Tumor in 31 participants. Completed in 25 September 2024.

Timeline

21 March 2022

Primary endpoint
4 March 2024

25 September 2024

Quick facts

Lead sponsor	Byondis B.V.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	21 March 2022
Primary completion	4 March 2024
Estimated completion	25 September 2024
Sites	4 locations across Belgium, Italy, Netherlands, United Kingdom

Drugs / interventions tested

BYON3521 — full drug profile →

Conditions studied

Solid Tumor — all drugs for Solid Tumor →

Sponsor

Byondis B.V. — full company profile →

Who can join

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

Sponsor's own description

This is the first-in-human trial with BYON3521, an antibody-drug conjugate (ADC) comprising a humanized IgG1 monoclonal antibody directed against the c-MET receptor covalently conjugated to a duocarmycin-containing linker-drug.

Publications & conference data

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

Angiogenic signaling pathways and anti-angiogenic therapy for cancer.
Liu ZL, Chen HH, Zheng LL, Sun LP, et al · · 2023 · cited 808× · PMID 37169756 · DOI 10.1038/s41392-023-01460-1
The Evolving Landscape of Antibody-Drug Conjugates: In Depth Analysis of Recent Research Progress.
Sasso JM, Tenchov R, Bird R, Iyer KA, et al · · 2023 · cited 89× · PMID 37821099 · DOI 10.1021/acs.bioconjchem.3c00374
Resistance to antibody-drug conjugates: A review.
Li S, Zhao X, Fu K, Zhu S, et al · · 2025 · cited 32× · PMID 40177568 · DOI 10.1016/j.apsb.2024.12.036
Delivery of Drugs into Cancer Cells Using Antibody-Drug Conjugates Based on Receptor-Mediated Endocytosis and the Enhanced Permeability and Retention Effect.
Tashima T. · · 2022 · cited 24× · PMID 36546903 · DOI 10.3390/antib11040078
Angiogenesis and targeted therapy in the tumour microenvironment: From basic to clinical practice.
Yang S, Fang Y, Ma Y, Wang F, et al · · 2025 · cited 22× · PMID 40268524 · DOI 10.1002/ctm2.70313
c-MET and the immunological landscape of cancer: novel therapeutic strategies for enhanced anti-tumor immunity.
Jabbarzadeh Kaboli P, Roozitalab G, Farghadani R, Eskandarian Z, et al · · 2024 · cited 12× · PMID 39664377 · DOI 10.3389/fimmu.2024.1498391
Antibody drug conjugates in the clinic.
Udofa E, Sankholkar D, Mitragotri S, Zhao Z. · · 2024 · cited 12× · PMID 39545074 · DOI 10.1002/btm2.10677
Advancements in antibody-drug conjugates as cancer therapeutics.
Fong JY, Phuna Z, Chong DY, Heryanto CM, et al · · 2025 · cited 11× · PMID 40814440 · DOI 10.1016/j.jncc.2025.01.007

Verify or expand the search:

Other recruiting trials for Solid Tumor

Currently open trials in the same condition.

NCT07489378 — NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rar · recruiting
NCT07487597 — Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors · EARLY_PHASE1 · recruiting
NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
NCT07466160 — A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07450560 — Research on Real-time Proton Therapy Guidance Through Monitoring Proton Range Using All-digital PET · active not recruiting

Other Byondis B.V. trials

Trials by the same sponsor.

NCT04983238 — Evaluation of Safety and Efficacy of Sodium Thiosulfate (BYON5667) Eye Drops to Reduce Ocular Toxicity in Cancer Patient · Phase 1, PHASE2 · completed
NCT04235101 — Phase I Study of SYD985 With Niraparib in Patients With Solid Tumors · Phase 1 · completed
NCT04205630 — SYD985 in Patients With HER2-expressing Recurrent, Advanced or Metastatic Endometrial Carcinoma · Phase 2 · completed
NCT04202705 — A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate SYD1875 · Phase 1 · completed
NCT03262935 — SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer · Phase 3 · completed

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 NCT05323045 (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 Byondis B.V.
Last refreshed: 9 July 2025

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/NCT05323045.

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