AT03-65 / Axcynsis Therap - LARVOL DELTA

FIH Study to Evaluate Safety, Tolerability, PK, PD & Preliminary Efficacy of AT03-65 With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=83 | Recruiting | Sponsor: Axcynsis Therapeutics Pte Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Platinum resistant • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Solid Tumor • ALK • BRAF • CLDN6 • EGFR • RET

FIH Study to Evaluate Safety, Tolerability, PK, PD & Preliminary Efficacy of AT03-65 With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=83 | Not yet recruiting | Sponsor: Axcynsis Therapeutics Pte Ltd | Initiation date: Aug 2025 ➔ Nov 2025

Trial initiation date • Solid Tumor

FIH Study to Evaluate Safety, Tolerability, PK, PD & Preliminary Efficacy of AT03-65 With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=78 | Not yet recruiting | Sponsor: Axcynsis Therapeutics Pte Ltd

New P1 trial • Oncology • Solid Tumor

Axcynsis Therapeutics Receives FDA Clearance for IND Application of AT03-65, a Differentiated CLDN6-Targeting ADC, Powered by AxcynDOT Technology (PRNewswire-Asia) - "Axcynsis Therapeutics Pte Ltd...announces the clearance of its Investigational New Drug application (IND) by the United States Food and Drug Administration (FDA) of AT03-65 for the treatment of patients with CLDN-6 positive solid tumors. Axcynsis is planning to initiate a Phase 1 multicentre clinical trial in the United States in 1Q 2025....The upcoming Phase 1 multicentre clinical trial in the United States will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of AT03-65 in patients with advanced CLDN6-positive solid tumors."

IND • New P1 trial • Solid Tumor