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

JRCT ID: jRCT2031230200

Registered date:01/07/2023

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

Gastric cancer
Gastro-esophageal junction cancer
Pancreatic ductal adenocarcinoma
Esophageal aden

• Date of first enrollment: 12/07/2023
• Target sample size: 200
• Countries of recruitment: US,Japan,Suoth Korea,Japan,Taiwan,Japan,China,Japan,UK,Japan,France,Japan,Netherland,Japan
• Study type: Interventional

Intervention(s)

The study consists of individual modules each evaluating the safety and tolerability of AZD5863 dosed as monotherapy:
- Module 1: AZD5863 intravenous administration
- Module 2: AZD5863 subcutaneous administration
Modules 1 and 2 each consist of two parts: Part A, Dose Escalation and Part B, Dose Expansion.

Outcome(s)

Primary Outcome

- Incidence of Adverse Events (AEs), Adverse Event of Special Interest (AESIs), Dose-limiting Toxicities (DLTs

- dose escalation only) and Serious Adverse Events (SAEs)

- AEs leading to discontinuation of AZD5863

- Assess clinically significant alterations in vital signs and abnormal laboratory parameters

- Objective response rate (ORR) according to RECIST v1.1 (dose expansion only)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Age 18 or more 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 RECIST v1.1

- Must show positive CLDN18.2 expression in tumor cells as determined by central IHC

- Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening

- Predicted life expectancy of 12 weeks or more

- 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

Exclude criteria

- Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or more except for those defined by the protocol

- Participant experienced unacceptable CRS or ICANS following prior TCE or CAR-T cell therapy

- Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment

- Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activation syndrome (MAS)

- CNS metastases or CNS pathology, as defined by the protocol, within 3 months prior to consent

- Infectious disease including active HIV, active hepatitis B/C, 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

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT06005493