ASKB589 / Aosaikang Pharma - LARVOL DELTA

Second-line ASKB589 plus chemotherapy for advanced gastric or gastroesophageal cancers: Results from cohort 5 of a phase I/II study. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT04632108 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • P1/2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Oncology • Solid Tumor

Humanized PD1 mouse with MC38-hCLDN18.2 cell line provide powerful syngeneic model platform for evaluating Claudin18.2-targeted therapies (AACR 2025) - "Human PD-1 protein expression was validated by FACS analysis after in vivo anti-CD3 stimulation.The tumor growth inhibition of two CLDN18.2 monoclonal antibodies (IMAB362 and ASKB589) was evaluated in hPD1 mice engrafted with MC38-CLDN18.2 syngeneic tumors. The therapeutic effects of these antibodies were also investigated in combination with anti-PD-1 treatment. Both anti-CLDN18.2 monotherapies demonstrated moderate antitumor efficacy, while their combination with PD-1/PD-L1 immune checkpoint blockade produced significant synergistic effects, resulting in enhanced tumor suppression and increased antitumor immunity with robust T-cell infiltration.In summary, the humanized PD-1 mouse model and MC38-CLDN18.2 cell line provide robust in vivo platforms to evaluate novel therapeutic candidates targeting CLDN18.2."

IO biomarker • Preclinical • Colon Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18 • PD-1

Updated efficacy results of ASKB589 combined with CAPOX and PD-1 inhibitor as first-line treatment for metastatic gastric/gastro-esophageal junction (G/GEJ) adenocarcinoma from a phase Ib/II study. (ASCO-GI 2025) - P1/2 | "The combination of ASKB589 with CAPOX and a PD-1 inhibitor as the initial treatment for pts with G/GEJ cancer was well tolerated with no unexpected safety signals. It has shown a high confirmed ORR, 100% disease control, deep and durable antitumor activity, regardless of PD-L1 expression levels. A phase 3 study of the triple regimen for the 1L G/GEJ cancer is actively enrolling pts in China."

Clinical • IO biomarker • Metastases • P1/2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • CLDN18 • PD-L1

ASKB589 in Combination With CAPOX and PD-1 Inhibitor in Patients With Advanced or Metastatic GC/GEJ Adenocarcinoma (clinicaltrials.gov) - P3 | N=780 | Recruiting | Sponsor: AskGene Pharma, Inc. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

A phase Ib/II study of ASKB589 (anti-Claudin 18.2 [CLDN18.2] monoclonal antibody) combined with CAPOX and PD-1 inhibitor as first-line treatment for locally advanced, relapsed and metastatic gastric/gastro-esophageal junction (G/GEJ) adenocarcinoma. (ASCO-GI 2024) - P1/2 | "We report preliminary safety and efficacy data from an ongoing Phase Ib/II, dose-escalation and expansion study of ASKB589 combined with capecitabine, oxaliplatin(CAPOX) and Sintilimab as first-line treatment of G/GEJ adenocarcinoma (NCT05632939). ASKB589 combined with CAPOX and PD-1 inhibitor has manageable safety and promising antitumor activity. 6mg/kg is chosen as the recommended dose in subsequent studies. Clinical trial information: NCT05632939."

Clinical • IO biomarker • Metastases • P1/2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • CLDN18

Aosaikang: Subsidiary's biopharmaceutical innovative drug ASKB589's registration clinical phase III study completed administration to China's first patient [Google translation] (163.com) - "Aosaikang announced on January 26 that the registration clinical phase III study of ASKB589, an innovative biological drug independently developed by the company's subsidiary AskGene Limited, for the first-line treatment of advanced gastric cancer has completed administration of the first patient in China....The study is a multi-center, randomized, double-blind, standard treatment- controlled, superior-efficiency design phase III clinical study. It plans to enroll 780 first-line gastric cancer patients in China and aims to evaluate ASKB589 injection or placebo combined with CAPOX (Austria)."

Trial status • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

ASKB589 Plus CAPOX and Sintilimab Demonstrates Early Efficacy in Gastric/GEJ Cancers (OncLive) - P1/2 | N=57 | NCT05632939 | Sponsor: AskGene Pharma, Inc. | "The primary end points of the study included identification of the maximum tolerated dose and recommended phase 3 dose, safety and tolerability, and DLTs....The median age of all patients in the trial (n = 62) was 59.0 years (range, 30-75) and most patients were male (66.1%). Additionally, most patients had an ECOG performance score of 1 (66.1%), 0 to 2 sites of metastases (75.8%), gastric cancer (87.1%) as opposed to GEJ (12.9%), and had not received prior gastrectomy (88.7%). Lauren types included diffuse (17.7%), intestinal (14.5%), mixed (8.1%), and unknown (59.7%), and patients had PD-L1 combined positive scores of less than 1 (40.3%), 1 to 5 (22.6%), and 5 or higher (37.1%)."

P1/2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

ASKB589 in Combination With CAPOX and PD-1 Inhibitor in Patients With Advanced, and Unresectable G/GEJ Cancer (clinicaltrials.gov) - P3 | N=780 | Not yet recruiting | Sponsor: AskGene Pharma, Inc.

Combination therapy • Metastases • New P3 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

A phase I/II study of ASKB589 (Anti-Claudin 18.2 (CLDN18.2) monoclonal antibody) in patients with solid tumors (IGCC 2023) - No abstract available

Clinical • P1/2 data • Oncology • Solid Tumor • CLDN18

A phase I/II study of ASKB589 (anti-claudin 18.2 [CLDN18.2] monoclonal antibody) in patients with solid tumors. (ASCO-GI 2023) - P1/2 | "In Part B, pts with gastric/gastro-esophageal junction (G/GEJ) cancers received ASKB589 IV at doses of 3, 6, 10 or 15 mg/kg Q3W in combination with capecitabine plus oxaliplatin. ASKB589 showed a manageable safety profile up to doses of 20 mg/kg and promising antitumor activity, both as monotherapy and in combination with chemotherapy. Clinical trial information: NCT04632108."

Clinical • P1/2 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

ASKB589 in Combination With CAPOX and Sintilimab in Patients With Advanced, and Unresectable G/GEJ Cancer. (clinicaltrials.gov) - P1/2 | N=57 | Recruiting | Sponsor: AskGene Pharma, Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2024 ➔ Feb 2026 | Trial primary completion date: Dec 2023 ➔ Feb 2025

Combination therapy • Enrollment open • Metastases • Trial completion date • Trial primary completion date • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=214 | Recruiting | Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Recruiting | Trial completion date: Nov 2023 ➔ Dec 2025 | Trial primary completion date: Sep 2023 ➔ Dec 2024

Enrollment open • Metastases • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

"#GI23 ➡️And there are6⃣other Ph 1 trials of Cldn 18.2🎯💊: ✅AB011➕CAPEOX 👁️J Li, Abs 391 ✅MIL93 👁️J Huang, Abs 798 ✅ADC CMG901 👁️RH Xu, Abs 352 ✅ASKB589 👁️BD Hickingbottom, Abs 397 ✅A Claudin 18.2-CAR-T 👁️DB Zhen, Abs TPS480 ✅Q-1802, a CLDN18.2/PD-L1 bsABs 👁️XQu, Abs 382" (@TumorBoardTues)

Gastrointestinal Cancer • CLDN18 • PD-L1

ASKB589 in Combination With CAPOX and Mentsimab in Patients With Locally Advanced or Metastatic Solid Tumors. (clinicaltrials.gov) - P1/2 | N=57 | Not yet recruiting | Sponsor: AskGene Pharma, Inc.

Combination therapy • New P1/2 trial • Oncology • Solid Tumor • CLDN18

A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2; N=1; Active, not recruiting; Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.; Recruiting ➔ Active, not recruiting; N=214 ➔ 1; Trial completion date: Nov 2022 ➔ Nov 2023; Trial primary completion date: Sep 2022 ➔ Sep 2023

Clinical • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2; N=214; Recruiting; Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2; N=214; Not yet recruiting; Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Clinical • New P1/2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor