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Phase I/II 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

Hibi Kazushige

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka

RD-clinical-information-Japan@astrazeneca.com

Hibi Kazushige

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka

+81-6-4802-3533

RD-clinical-information-Japan@astrazeneca.com

Recruiting

July. 07, 2023

Interventional

randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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

- 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

Both

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

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.

- 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)

+81-3-3542-2511

July. 03, 2023

No

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

US/Suoth Korea/Taiwan/China/UK/France/Netherland