BYON3521 / Byondis - LARVOL DELTA

BYON3521.001: A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate BYON3521 (clinicaltrials.gov) - P1 | N=31 | Active, not recruiting | Sponsor: Byondis B.V. | Recruiting ➔ Active, not recruiting | N=120 ➔ 31 | Trial completion date: Mar 2025 ➔ Jul 2024 | Trial primary completion date: Jan 2025 ➔ Jul 2024

Enrollment change • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Endometrial Cancer • Gastrointestinal Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • MET

Translational Pharmacology of a Novel Site-Specifically Conjugated Anti-c MET Antibody Drug Conjugate BYON3521 (ADC-USA 2023) - "Discussing how BYON3521 has demonstrated potent and selective killing of c-MET expressing tumor cells in preclinical models, even at low c-MET expression levels; Describing how the ongoing dose-escalation part of the first-in-human (FiH) clinical study showed that the human PK was in line with the predicted preclinical in vivo PK.; Outlining the initial FiH study data which indicates that BYON3521 is well-tolerated up to 4.8 mg/kg"

Oncology • MET

First in human dose-escalation trial with the c-MET targeting antibody-drug conjugate BYON3521 (AACR 2023) - P1 | "To date, BYON3521 is well-tolerated with no DLTs at the investigated dose levels. Patient enrollment is ongoing and updated safety, efficacy and pharmacokinetic data will be presented. After the dose-escalation phase the trial will continue with expanded cohorts of patients with specific c-MET expressing cancer types."

P1 data • Colorectal Cancer • Esophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • MET

Preclinical profile of BYON3521 predicts an effective and safe c-MET-antibody-drug conjugate. (PubMed, Mol Cancer Ther) - P1 | "In all, our nonclinical data suggests that BYON3521 is a safe ADC with potential for clinical benefit in patients. A first-in-human dose escalation study is currently ongoing to determine the maximum tolerated dose and recommended dose for expansion (NCT05323045)."

Journal • Preclinical • Oncology • Solid Tumor • HGF • MET

Preclinical Data on the Potential of Byondis ADC BYON3521 Published in Molecular Cancer Therapeutics (PRNewswire) - "Byondis B.V...announced that Molecular Cancer Therapeutics (an American Association for Cancer Research journal) has published encouraging preclinical data on its investigational, next generation antibody-drug conjugate (ADC) BYON3521....The data from in vitro and in vivo studies showed that BYON3521 potently and selectively kills tumor cells expressing c-MET, even at low c-MET-expressing levels. In addition, the nonclinical safety evaluation showed that BYON3521 is well tolerated, predicting a substantial clinical therapeutic window."

Preclinical • Oncology • Solid Tumor

Byondis Initiates Phase I Study of Next Generation Antibody-Drug Conjugate BYON3521 (PRNewswire) - "Byondis B.V....announced that the first cancer patients have been dosed with its investigational antibody-drug conjugate (ADC) BYON3521. The 'First-in-Human Dose-Escalation and Expansion Trial With the Antibody-Drug Conjugate BYON3521 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients with c-MET-Expressing Locally Advanced or Metastatic Solid Tumors' (BYON3521.001/NCT05323045) is currently enrolling patients in leading oncology centers in Belgium, Italy, the Netherlands and the U.K."

Trial status • Oncology • Solid Tumor

A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate BYON3521 (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Byondis B.V.

New P1 trial • Head and Neck Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • MET

[VIRTUAL] BYON3521, a novel effective and safe c-Met targeting antibody-drug conjugate (AACR 2021) - "In all, BYON3521 was deemed a safe ADC with potential for clinical benefit in patients. Preparations are ongoing to start clinical Phase I in 2021."

Oncology • Solid Tumor • MET