NCT06005493

Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors

Recruiting now Phase 1, PHASE2 Last updated 24 February 2026

What this trial tests

Phase 1, PHASE2 trial testing AZD5863 in Gastric Cancer in 280 participants. Currently enrolling.

Timeline

11 July 2023

Primary endpoint
16 July 2027

16 July 2027

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	280
Start date	11 July 2023
Primary completion	16 July 2027
Estimated completion	16 July 2027
Sites	25 locations across France, Japan, Netherlands, Taiwan, United Kingdom, South Korea, China, United States

Drugs / interventions tested

• AZD5863 — full drug profile →

Conditions studied

• Gastric Cancer — all drugs for Gastric Cancer →
• Gastro-esophageal Junction Cancer — all drugs for Gastro-esophageal Junction Cancer →
• Pancreatic Ductal Adenocarcinoma — all drugs for Pancreatic Ductal Adenocarcinoma →
• Esophageal Adenocarcinoma — all drugs for Esophageal Adenocarcinoma →

Sponsor

AstraZeneca — full company profile →

Who can join

18 and older, any sex, with Gastric Cancer or Gastro-esophageal Junction Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This research is designed to determine if experimental treatment with AZD5863, a T cell-engaging bispecific antibody that targets Claudin 18.2 (CLDN18.2) and CD3, is safe, tolerable and has anti-cancer activity in patients with advanced solid tumors.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical Progresses and Challenges of Bispecific Antibodies for the Treatment of Solid Tumors.
   Gu Y, Zhao Q. · · 2024 · cited 16× · PMID 39172329 · DOI 10.1007/s40291-024-00734-w
2. Unveiling the resistance to therapies in pancreatic ductal adenocarcinoma.
   Shah A, Ganguly K, Rauth S, Sheree SS, et al · · 2024 · cited 14× · PMID 39243602 · DOI 10.1016/j.drup.2024.101146
3. Bispecific Antibodies in Solid Tumors: Advances and Challenges.
   Shan KS, Musleh Ud Din S, Dalal S, Gonzalez T, et al · · 2025 · cited 12× · PMID 40565299 · DOI 10.3390/ijms26125838
4. Claudin 1, 4, 6 and 18 isoform 2 as targets for the treatment of cancer (Review).
   Katoh M, Katoh M. · · 2024 · cited 9× · PMID 39301632 · DOI 10.3892/ijmm.2024.5424
5. Claudin 18.2 Expression in 1404 Digestive Tract Adenocarcinomas Including 1175 Colorectal Carcinomas: Distinct Colorectal Carcinoma Subtypes Are Claudin 18.2 Positive.
   McHugh KE, Pai RK, Grant RC, Gallinger S, et al · · 2025 · cited 7× · PMID 39826799 · DOI 10.1016/j.modpat.2025.100712
6. Claudins: from gatekeepers of epithelial integrity to potential targets in hepato-pancreato-biliary cancers.
   Jeon H, Sterpi M, Mo C, Bteich F. · · 2024 · cited 7× · PMID 39391254 · DOI 10.3389/fonc.2024.1454882
7. Dark horse target Claudin18.2 opens new battlefield for pancreatic cancer.
   Xu Q, Jia C, Ou Y, Zeng C, et al · · 2024 · cited 7× · PMID 38511141 · DOI 10.3389/fonc.2024.1371421
8. Emerging Immunotherapy Targets in Early Drug Development.
   Morchón-Araujo D, Catani G, Mirallas O, Pretelli G, et al · · 2025 · cited 6× · PMID 40508202 · DOI 10.3390/ijms26115394