This clinical performance study will evaluate the effectiveness of the CLDN18.2 (SP455) Clinical Trial Assay in identifying CLDN18.2 status in Adult Participants with Advanced or Metastatic Solid Tumours treated with AZD5863.
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Performance study endpoint is to demonstrate that the CLDN18.2 (SP455) CTA is
safe and effective to identify patients for AZD5863, as supported by the
efficacy and safety endpoints from the D9750C00001 clinical trial as defined by
the ORR.
Secondary outcome
Not applicable.
Background summary
This clinical performance study protocol (CPSP) relates to the use of the
CLDN18.2 (SP455) Clinical Trial Assay (CTA) to identify and select CLDN18.2
positive (CLDN18.2 expression level >=25% in tumor cells) gastric/GEJ carcinoma,
esophageal adenocarcinoma, and pancreatic cancer patients for recruitment into
the AstraZeneca 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 (D9750C00001).
Study objective
This clinical performance study will evaluate the effectiveness of the CLDN18.2
(SP455) Clinical Trial Assay in identifying CLDN18.2 status in Adult
Participants with Advanced or Metastatic Solid Tumours treated with AZD5863.
Study design
The CLDN18.2 (SP455) Clinical Trial Assay is an investigational device intended
to identify CLDN18.2 expression in adult participants with advanced metastatic
solid tumours, gastric/GEJ carcinoma, esophageal adenocarcinoma, and pancreatic
cancer in formalin-fixed, paraffin-embedded (FFPE) tissue as part of the
enrolment criteria for clinical drug trial D9750C00001.
Outcome data from clinical drug trial D9750C00001 will be used to evaluate the
clinical performance of CLDN18.2 (SP455) Clinical Trial Assay as an IVD for
AZD5863 as a monotherapy or in combination in patients with advanced or
metastatic solid tumours,
The study consists of Module 1 (AZD5863 monotherapy intravenously) and Module 2
(AZD5863 monotherapy subcutaneously), and each module will contain dose
escalation (part A) and dose-expansion (part B).
Participants will be based on prospective testing of CLDN18.2 expression using
the device described in this clinical performance study protocol.
Intervention
If not present: collection of a tumor biopsy.
Study burden and risks
A new biopsy may have to be collected during screening if there is no or not
enough tissue available.
Prinses Beatrixlaan 582
Den Haag 2595BM
NL
Prinses Beatrixlaan 582
Den Haag 2595BM
NL
Listed location countries
Age
Inclusion criteria
- Histologically confirmed diagnosis of adenocarcinoma of the stomach,
gastro-esophageal junction, esophagus, or pancreas
- Participants must have received at least one prior line of systemic therapy
in the advanced/metastatic setting
- ECOG performance status of 0 or 1 at screening
- Predicted life expectancy of >= 12 weeks
- Must have at least one measurable lesion according to RECIST v1.1
- Participants must show CLDN18.2 expression in >=25% tumor cells as determined
by central IHC. Archival tissue blocks up to 3 years old or archival cut slides
up to 6 months old (from the time of signing pre-screening ICF) or fresh tissue
are all acceptable for IHC
Exclusion criteria
- Unresolved toxicity from prior anticancer therapy of Common Terminology
Criteria for Adverse Events (CTCAE) Grade >= 2 except for vitiligo, alopecia,
etc. - Participant experienced Grade >=3 CRS or Grade >=2 ICANS based on ASTCT
criteria following prior TCE or CAR-T cell therapy - Active or prior documented
autoimmune or inflammatory disorders - CNS metastases or CNS pathology
including: epilepsy, seizures, paresis, aphasia etc. Participants with brain
metastases treated, asymptomatic, stable, and not requiring continuous
corticosteroids at a dose of > 10 mg prednisone/day are allowed - Participants
with clinically significant ascites that require drainage. - Oesophageal cancer
with airway involvement. - Infectious disease including active HIV, active hep
B/C, uncontrolled active systemic fungal, bacterial or other infection
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | EU-CT number: 2023-504139-42 |
| CCMO | NL86495.000.24 |