A Master Protocol of an Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Novel Combinations in Participants with Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510977-27-00

Acronym

D7986C00001

Enrollment

Registered

2024-04-04

Start date

2023-04-14

Completion date

Unknown

Last updated

2025-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Brief summary

ORR in response evaluable set, PFS6 in full analysis set

Detailed description

DoR per RECIST 1.1 based on Investigator assessment., PFS per RECIST 1.1 as assessed by the Investigator., OS., Incidence of AEs, AESIs, and SAEs; physical examination; Laboratory findings; vital signs; 12-lead ECG., Incidences of ADAs against novel agent in serum., Serum concentrations of novel agent and derived PK parameters.

Interventions

DRUGOXALIPLATIN

DRUGFLUOROURACIL

DRUGRilvegostomig

DRUGCAPECITABINE

DRUGCALCIUM FOLINATE

DRUGAZD7789

DRUGvolrustomig

DRUGAZD0901

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
ORR in response evaluable set, PFS6 in full analysis set	—

Secondary

Measure	Time frame
DoR per RECIST 1.1 based on Investigator assessment., PFS per RECIST 1.1 as assessed by the Investigator., OS., Incidence of AEs, AESIs, and SAEs; physical examination; Laboratory findings; vital signs; 12-lead ECG., Incidences of ADAs against novel agent in serum., Serum concentrations of novel agent and derived PK parameters.	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026