ACR246 / Adcoris - LARVOL DELTA

ACR246-101: An Open-label, Multi-center, Dose-escalation and Cohort Expansion Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Efficacy of ACR246 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=77 | Recruiting | Sponsor: Hangzhou Adcoris Biopharmacy Co., Ltd | Trial completion date: Jan 2026 ➔ Nov 2026 | Trial primary completion date: Jun 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Solid Tumor

A phase I/IIa clinical trial of ACR246, an anti-5T4 antibody drug conjugate (ADC), in patients (pts) with advanced solid tumors [WITHDRAWN] (ESMO 2025) - No abstract available

Clinical • Metastases • P1/2 data • Oncology • Solid Tumor

ACR246, a novel 5T4 antibody-drug conjugate, showed promising anticancer efficacy in esophageal squamous cell carcinoma (ESMO 2025) - "Results In three CIR-ESCC PDOs, ACR246 was superior to irinotecan, anlotinib and apatinib in suppression of tumor growth. Conclusions ACR246 exhibited potent anti-cancer efficacy across 5T4-high, moderate and low expression ESCC PDX and CIR-PDO models, supporting its clinical potential for ICI-refractory ESCC pts. Legal entity responsible for the study Hangzhou Adcoris Biopharma Co., Ltd."

Clinical • IO biomarker • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • CD8 • IFNG • TPBG

ACR246, a first in next-generation 5T4-ADC, as a potential choice of treating 5T4-positive solid tumors. (J Clin Oncol) - "Our results showed that ACR246 significant inhibited the proliferation of 5T4-positive cells, with IC 50 values ranging from 40.0 to 372.4 nM. It bound specifically to 5T4 positive tumors cell with sub-nanomolar EC 50 , and was internalized into tumor cells rapidly, but these were not observed in 5T4 negative cells. In the 5T4-positive esophageal cancer PDO models, ACR246 also exhibited stronger anti-tumor activity than other clinical drugs, such as irinotecan and anlotinib...In vivo anti-tumor studies confirmed the higher efficacy of ACR246 compared to chemotherapy or Dxd-ADC in inhibiting tumor growth, in both 5T4-positive CDX and PDX models ( P < 0.05). In murine esophageal cancer model expressing human 5T4 protein, ACR246 could sensitize the anti-PD1 treatment through creating a more immunologically active tumor microenvironment. PK study demonstrated low systemic exposure of payload D2102 after intravenous administration of ACR246 in cynomolgus monkeys..."

Preclinical • Breast Cancer • Esophageal Cancer • Gastric Cancer • Lung Cancer • Pancreatic Cancer

ACR246, a first in next-generation 5T4-ADC, as a potential choice of treating 5T4-positive solid tumors. (ASCO 2025) - P1 | "In the 5T4-positive esophageal cancer PDO models, ACR246 also exhibited stronger anti-tumor activity than other clinical drugs, such as irinotecan and anlotinib. ACR246 exhibits a promising anti-tumor activity and potentiate the anti-PD1 efficacy in multiple 5T4-positive tumors. We have now translated this preclinical result into a phase 1/2a clinical trial (NCT06238401) to assess the safety and efficacy of ACR246 treatment."

IO biomarker • Esophageal Cancer • Gastric Cancer • Lung Cancer • Oncology • Solid Tumor • TPBG

A dose escalation and cohort expansion phase I/IIa study of ACR246, an innovative 5T4- antibody drug conjugate (ADC), in patients (pts) with advanced solid tumors. (ASCO 2025) - P1 | "The toxicity will be assessed by Common Terminology Criteria for Adverse Events v5.0 and the tumor response will be determined per RECIST v1.1. Dose levels of 0.6 mg/kg and 1.2mg/kg has completed enrollment with no DLT."

Clinical • Metastases • P1/2 data • Esophageal Cancer • Gastric Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • TPBG

ACR246-101: An Open-label, Multi-center, Dose-escalation and Cohort Expansion Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Efficacy of ACR246 in Patients with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=77 | Recruiting | Sponsor: Hangzhou Adcoris Biopharmacy Co., Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2024 ➔ Oct 2024 | Trial primary completion date: Jan 2025 ➔ Jun 2025

Enrollment open • Metastases • Trial initiation date • Trial primary completion date • Oncology • Solid Tumor

Phase I dose escalation trial to evaluate safety and preliminary efficacy of ACR246, an innovative 5T4- antibody drug conjugate (ADC), in patients (pts) with advanced solid tumors (ESMO 2024) - P1 | "Previously, several 5T4-ADCs were developed and advanced to phase 1 clinical trials, including PF-06263507, ASN004 and SYD1875. Dose limiting toxicity (DLT) will be assessed at each dose level. The DLT evaluation period will be 21 days."

Clinical • Metastases • P1 data • Oncology • Solid Tumor • TPBG

Preclinical studies of an innovative 5T4-ADC ACR246 with the potential to better treat 5T4-positive solid tumors. (ASCO 2024) - "The overall preclinical profile marks ACR246 has the potential to become the best in class (BIC) 5T4-ADC, showing more favorable benefit-risk ratio in clinic."

Preclinical • Oncology • Solid Tumor • CXCL12 • TPBG

Study of ACR246 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=77 | Not yet recruiting | Sponsor: Hangzhou Adcoris Biopharmacy Co., Ltd

New P1 trial • Oncology • Solid Tumor