Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1/Phase 2
AstraZeneca (Voir sur ClinicalTrials)
juillet 2023
juillet 2027
02 mars 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Christophe MASSARD | 17/06/2026 11:20:06 | Contacter | ||
Critères
Tous
- Age ≥ 18 at the time of signing the informed consent
- Histologically confirmed diagnosis of adenocarcinoma of the stomach,
gastro-esophageal junction, esophagus, or pancreas
- Must have at least one measurable lesion according to Response Evaluation Criteria
in Solid Tumors (RECIST) v1.1
- Must show positive CLDN18.2 expression in tumor cells as determined by central
immunohistochemistry (IHC)
- Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening
- Predicted life expectancy of ≥ 12 weeks
- Adequate organ and bone marrow function measured within 28 days prior to first dose
as defined by the protocol
- Contraceptive use by men or women should be consistent with local regulations, as
defined by the protocol
- Must have received at least one prior line of systemic therapy in the
advanced/metastatic setting
Key Exclusion Criteria:
- Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria for
Adverse Events (CTCAE) Grade ≥ 2 except for those defined by the protocol
- Participant experienced unacceptable cytokine release syndrome (CRS) or Immune
Effector Cell Associated Neurotoxicity (ICANS) following prior T cell engagers (TCE)
or chimeric antigen receptor T (CAR-T) cell therapy
- Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activation
syndrome (MAS)
- Active or prior documented autoimmune or inflammatory disorders within 3 years of
start of treatment
- central nervous system (CNS) metastases or CNS pathology, as defined by the
protocol, within 3 months prior to consent
- Infectious disease including active human immunodeficiency virus (HIV), active
hepatitis B/C, uncontrolled infection with EBV, uncontrolled active systemic fungal,
bacterial or other infection
- Cardiac conditions as defined by the protocol
- History of thromboembolic event within the past 3 months prior to the scheduled
first dose of study intervention
- Participant requires chronic immunosuppressive therapy
- Participants on anticoagulation therapy with long-acting anticoagulants or other
class of anticoagulants at therapeutic doses