Trials / Recruiting
RecruitingNCT06005493
Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors
A Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5863, a T Cell-engaging Bispecific Antibody That Targets Claudin 18.2 (CLDN18.2) and CD3 in Adult Participants With Advanced or Metastatic Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This is a first-time in human, modular Phase I/II, open-label multicentre study of AZD5863 monotherapy administered intravenously (Module 1), or AZD5863 monotherapy administered subcutaneously (Module 2) in patients with advanced or metastatic solid tumors. Each module contains dose-escalation (Part A) and dose-expansion (Part B).
Conditions
- Gastric Cancer
- Gastro-esophageal Junction Cancer
- Pancreatic Ductal Adenocarcinoma
- Esophageal Adenocarcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AZD5863 | T cell-engaging bi-specific antibody that targets CLDN18.2 (Claudin18.2) on tumor cells and CD3 on T cells |
Timeline
- Start date
- 2023-07-11
- Primary completion
- 2027-07-16
- Completion
- 2027-07-16
- First posted
- 2023-08-22
- Last updated
- 2026-02-24
Locations
25 sites across 8 countries: United States, China, France, Japan, Netherlands, South Korea, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06005493. Inclusion in this directory is not an endorsement.