DR30303 / Huadong Medicine, Zhejiang Doer Biologics - LARVOL DELTA

A Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of DR30303 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=13 | Terminated | Sponsor: Zhejiang Doer Biologics Co., Ltd. | N=94 ➔ 13 | Trial completion date: Jun 2025 ➔ Mar 2026 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2025 ➔ Dec 2025; This trial was terminated voluntarily by the Sponsor for reasons related to its corporate strategic development, with no safety concerns or efficacy signals related to the investigational product identified.

Enrollment change • First-in-human • Trial completion date • Trial primary completion date • Trial termination • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

A Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of DR30303 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=94 | Recruiting | Sponsor: Zhejiang Doer Biologics Co., Ltd. | Trial primary completion date: Jun 2024 ➔ Jun 2025

Metastases • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

A Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of DR30303 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=94 | Recruiting | Sponsor: Zhejiang Doer Biologics Co., Ltd. | Trial completion date: Apr 2024 ➔ Apr 2025 | Trial primary completion date: Sep 2023 ➔ Jun 2024

Metastases • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

Zhejiang Doer Biologics Announces Clinical Trial Collaboration with MSD to Evaluate DR30303 in Combination with KEYTRUDA (pembrolizumab) in Patients with Gastric or Gastroesophageal Junction Cancer (PRNewswire) - "Zhejiang Doer Biologics Co., Ltd....announced that it has entered into a clinical trial collaboration agreement with MSD...to investigate Doer Bio's anti-Claudin18.2 antibody DR30303, in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with Gastric or Gastroesophageal Junction Cancer. Under this agreement, Doer Bio will conduct a clinical study based on a mutually- agreed and finalized protocol, to evaluate the safety and efficacy of DR30303 in combination with KEYTRUDA® in patients with Claudin18.2-positive, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GC/GEJ) cancer."

Licensing / partnership • New trial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

A Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of DR30303 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=94 | Recruiting | Sponsor: Zhejiang Doer Biologics Co., Ltd.

New P1 trial • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

DR30303, a SMART-VHHBody powered anti-CLDN18.2 VHH-Fc with enhanced ADCC activity for the treatment of gastric and pancreatic cancers (AACR 2022) - "Single-agent therapeutic potency of DR30303 was demonstrated in various gastric and pancreatic cell-derived xenograft (CDX) mouse models with a minimum effective dose of 0.3 mg/kg dose of DR30303 led to TGI≥90%, which is significantly more potent (p<0.05) than the benchmark reference Zolbetuximab analog in same molar ratio. Moreover, DR30303 showed strong synergistic anti-tumor activities with paclitaxel, gemcitabine, and EOF (epirubicin, oxaliplatin, and fluorouracil) in patient-derived xenograft (PDX) mouse models (gastric cancer) and CDX model (pancreatic cancer). DR30303 also demonstrated favorable pharmacokinetic properties (t1/2~ 120 hours) and tolerable toxicities (MTD≥ 748.5 mg) in both SD rats and cynomolgus monkeys. Doer Biologics submitted IND to the NMPA in November 2021 and plans to initiate the Phase 1 clinical trial in H1 2022 upon IND approval."

Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18