AZD5863 / Harbour BioMed, AstraZeneca - LARVOL DELTA

D9750C00001: Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=392 | Recruiting | Sponsor: AstraZeneca | N=280 ➔ 392 | Trial completion date: Jul 2027 ➔ Mar 2029 | Trial primary completion date: Jul 2027 ➔ Mar 2029

Enrollment change • Trial completion date • Trial primary completion date • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

AZD5863: Data from P1 trial (NCT06005493) for solid tumors in H1 2027 (AstraZeneca) - H1 & Q2 2026 Results

P1 data • Oncology • Solid Tumor

AZD5863: Data from P1 trial (NCT06005493) for solid tumors in H2 2026 (AstraZeneca) - Q1 2026 Results

P1 data • Oncology • Solid Tumor

An anti-claudin 18.2/CD3 bispecific antibody for the treatment of claudin 18.2 positive gastric cancer (AACR 2024) - "However, Zolbetuximab (IMAB362) has successfully reached the Phase III end point, indicating positive clinical outcomes and establishing CLDN18.2 as a promising cellular and antibody therapeutic option. In conclusion, the novel anti-CLDN18.2 × anti-CD3 bispecific antibody LNF2007 demonstrates similar efficacy to AMG 910 and AZD5863 and is safer. LNF2007 provides a promising therapy for claudin 18.2-positive cancer patients.Taishan Industry Leading Talents Project of Shandong Province was a sponsor of this research."

Bispecific • IO biomarker • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

Enhancing AZD5863 (CLDN18.2 T cell engager) activity through combination with chemotherapy and rilvegostomig (PD-1 x TIGIT bispecific) (ESMO-IO 2025) - P1/2 | "Recent clinical success with zolbetuximab has validated CLDN18.2 as a therapeutic target in gastric cancer...Combinatorial activity was assessed with 5-FU/oxaliplatin, gemcitabine/paclitaxel, and rilvegostomig across multiple rounds of AZD5863 treatment...In vivo, combination of AZD5863 with 5-FU and oxaliplatin and a murine surrogate of rilvegostomig resulted in superior tumor growth inhibition, compared with monotherapies.Conclusions AZD5863 induces T cell activation, cytokine secretion, and tumor cell cytotoxicity in vitro, and in vivo. These effects are further potentiated in combination with clinically relevant chemotherapies or rilvegostomig."

IO biomarker • Gastric Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18 • PD-1 • TIGIT

AZD5863: Data from P1 trial (NCT06005493) for solid tumors in H2 2026 (AstraZeneca) - Q3 2025 Results

P1 data • Oncology • Solid Tumor

D9750C00001: Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=280 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Dec 2026 ➔ Jun 2027 | Trial primary completion date: Dec 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

An affinity-modulated T cell engager targeting Claudin 18.2 shows potent anti-tumor activity with limited cytokine release. (PubMed, J Immunother Cancer) - P1/2 | "AZD5863 mediates potent anti-tumor activity in vitro and in vivo, while inducing limited levels of cytokines. This work improves our understanding of the mechanism of action of affinity balanced TCEs and informs the design of a phase 1 trial testing AZD5863 in gastric, pancreatic, and esophageal adenocarcinoma (NCT06005493)."

Journal • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18 • FASLG • IFNG • TNFA

AZD5863, a CLDN18.2 and CD3 binding T-cell engager, establishes a multi-faceted antitumour immune response and combines effectively with chemo-immunotherapy regimens (SITC 2024) - P1/2 | "Studies performed in mice received Institutional Animal Care and Use Committee approval under protocol numbers AUP-22-17 and AUP-22-25. All patient samples were obtained with fully informed consent and their use was approved by AstraZeneca plc which operates under Human Tissue Act license number 12109."

IO biomarker • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD8 • CLDN18 • GZMB • IFNG • IL6 • TNFA

AZD5863: a specific, potent, affinity-optimized claudin 18.2 and CD3 binding T cell-engager that elicits low cytokine release and is capable of bystander killing (SITC 2023) - "2 is a validated therapeutic target; zolbetuximab, a CLDN18. 2-negative tumor cells. A phase 1 trial evaluating AZD5863 in gastric, pancreatic and esophageal adenocarcinoma, is ongoing."

Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18 • IL6 • TNFA

Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: AstraZeneca

Metastases • New P1/2 trial • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

Harbour BioMed Reports Full Year 2022 Financial Results (PRNewswire) - "In addition, HBM7022 (CLDN18.2xCD3), HBM7004 (B7H4x4-1BB), HBM9027 (PD-L1xCD40), HBM9033 (MSLN ADC), HBM1047 (CD200R1) and HBM9014 (LIFR) are all preclinical stage products in the company's pipeline. With the efficient output of the technology platforms as well as the rich expertise of our R&D team, the Company aims to file at least one IND each year moving forward."

IND • Oncology • Solid Tumor

"The Claudin18.2 bingo continues - $AZN licenses in a second asset (CMG901, an ADC from Keymed; licensed HBM7022, Harbour's T-cell engager, in Apr 2022)" (,@JacobPlieth)

CLDN18

Harbour BioMed Announces Global Out-License Agreement with AstraZeneca for CLDN18.2xCD3 Bispecific Antibody HBM7022 (PRNewswire) - "Harbour BioMed...announced a global out-license agreement with AstraZeneca...for CLDN18.2xCD3 bispecific antibody (HBM7022), a novel bispecific antibody generated from HBM's HCAb Based Immune Cell Engagers (HBICE®) Platform....Upon the execution of the license agreement and subject to terms and conditions thereof, AstraZeneca will be granted an exclusive global license for research, development, registration, manufacturing, and commercialization of HBM7022 and shall be solely responsible for all costs and activities associated with its further development and commercialization."

Licensing / partnership • Oncology