EBC-129 / A*Star, National Cancer Centre Singapore - LARVOL DELTA

EBC-129 Is Active and Safe in Heavily Pretreated mPDAC (OncLive) - P1A/B | N=95 | NCT05701527 | "EBC-129 monotherapy demonstrated antitumor activity and had a manageable safety profile in patients with heavily pretreated metastatic pancreatic ductal adenocarcinoma (mPDAC), according to early findings from a phase 1 trial (NCT05701527) that were presented at the 2025 ASCO Annual Meeting. Among the 20 evaluable patients with mPDAC, the objective response rate (ORR) was 20%, the disease control rate was 71.4%, and the median progression-free survival (PFS) was 12.9 weeks. Among evaluable patients treated at the 1.8-mg/kg dose (n = 8), the ORR was 25%, and the median PFS was 19.1 weeks. Among those treated at the 2.2-mg/kg dose (n = 10), the ORR was 20.0%, and the median PFS was 12.1 weeks."

P1 data • Pancreatic Ductal Adenocarcinoma

Experimental Drug Development Centre Granted U.S. FDA Fast Track Designation for Antibody-Drug Conjugate EBC-129 to Treat Pancreatic Ductal Adenocarcinoma (Canada Newswire) - "The Experimental Drug Development Centre (EDDC), Singapore's national platform for drug discovery and development, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for EBC-129 for the treatment of pancreatic ductal adenocarcinoma (PDAC)....Updated clinical data from the ongoing Phase 1 study of EBC-129 will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago from 30 May to 3 June 2025."

Fast track • P1 data • Pancreatic Ductal Adenocarcinoma

Clinical activity of EBC-129, a first-in class, anti N256-glycosylated CEACAM5 and CEACAM6 antibody-drug conjugate (ADC), in patients with pancreatic ductal adenocarcinoma (PDAC) in a phase 1 study. (ASCO 2025) - P1 | "EBC-129 shows promising clinical activity in heavily treated PDAC patients with a manageable tolerability profile, consistent with MMAE-based ADCs. Further evaluation of EBC-129 in PDAC, both as monotherapy and in combination with chemotherapy, is planned. (NCT05701527)."

Clinical • P1 data • Anemia • Neutropenia • Oncology • Pain • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CEACAM5 • CEACAM6

EBC-129-01: A Study of EBC-129 in Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: EDDC (Experimental Drug Development Centre), A*STAR Research Entities | Trial completion date: Jun 2026 ➔ Dec 2026 | Trial primary completion date: Jun 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Solid Tumor

A phase I dose escalation study of EBC-129, a first-in class, anti N-glycosylated CEACAM5 & CEACAM6 antibody-drug conjugate (ADC) in patients with solid tumors (ESMO 2024) - P1 | "EBC-129 is the first ADC to target N256C5/6 and has shown promising early activity in a heavily pre-treated population. Additional targeting of C6 did not increase toxicity seen with MMAE-linked ADCs. Three expansion cohorts (n=15 each) in IHC positive gastroesophageal or other cancers, and in pancreatic cancer (IHC positive or ≥ 1% expression at 3+) are ongoing."

Clinical • P1 data • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CEACAM5 • CEACAM6

First made-in-Singapore antibody-drug conjugate EBC-129 progresses to phase 1B dose expansion (Eurekalert) - "The Experimental Drug Development Centre (EDDC), Singapore’s national platform for drug discovery and development, is pleased to announce that the Phase 1 trial for EBC-129 has progressed into dose expansion....The Phase 1 trial has now progressed into dose expansion, with the first patient for this part of the study dosed on 13th May 2024."

Trial status • Oncology • Solid Tumor

A Study of EBC-129 in Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: EDDC (Experimental Drug Development Centre), A*STAR Research Entities | Trial completion date: May 2025 ➔ Jun 2026 | Trial primary completion date: Apr 2025 ➔ Jun 2026

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A Study of EBC-129 in Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: EDDC (Experimental Drug Development Centre), A*STAR Research Entities | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Oncology • Solid Tumor

A Study of EBC-129 in Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=84 | Not yet recruiting | Sponsor: EDDC (Experimental Drug Development Centre), A*STAR Research Entities | Trial primary completion date: Mar 2024 ➔ Apr 2025

Combination therapy • Metastases • Trial primary completion date • Oncology • Solid Tumor

WuXi XDC Congratulates EDDC on FDA Clearance of IND Application for First Made-in-Singapore Antibody-Drug Conjugate (PRNewswire) - "WuXi XDC...congratulates its partner, the Experimental Drug Development Centre (EDDC), Singapore's national drug discovery and development platform hosted by the Agency for Science, Technology and Research (A*STAR), and its collaborators on clearance by the U.S. FDA for EBC-129 to begin its first-in-human trial in patients with solid tumors. EBC-129 is the first made-in-Singapore antibody-drug conjugate (ADC). With the employment of WuXi XDC's proprietary integrated technology platforms, all of the CMC studies for EBC-129's Investigational New Drug (IND) application were completed effectively and at the highest level of quality."

IND • Oncology • Solid Tumor

A Study of EBC-129 in Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=84 | Not yet recruiting | Sponsor: EDDC (Experimental Drug Development Centre), A*STAR Research Entities | Trial primary completion date: Mar 2025 ➔ Mar 2024

Combination therapy • Metastases • Trial primary completion date • Oncology • Solid Tumor

A Phase 1 Study of EBC-129 in Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=84 | Not yet recruiting | Sponsor: EDDC (Experimental Drug Development Centre), A*STAR Research Entities

Combination therapy • Metastases • New P1 trial • Oncology • Solid Tumor