Trial record 1 of 1 for: D7986C00001

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Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT05702229

Recruitment Status : Recruiting

First Posted : January 27, 2023

Last Update Posted : April 23, 2024

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

Tracking Information

First Submitted Date ^ICMJE

December 7, 2022

First Posted Date ^ICMJE

January 27, 2023

Last Update Posted Date

April 23, 2024

Actual Study Start Date ^ICMJE

January 16, 2023

Estimated Primary Completion Date

September 30, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

ORR (per RECIST 1.1 as assessed by Investigator) [ Time Frame: Through substudy completion, an average of 2 years ]
the proportion of participants who have a confirmed complete response or confirmed partial response, as determined by the Investigator at local site per RECIST 1.1.
PFS6 (per RECIST 1.1 as assessed by Investigator) [ Time Frame: Through substudy completion, an average of 2 years ]
the proportion of participants alive and progression-free at 6 months.

Original Primary Outcome Measures ^ICMJE

ORR (per RECIST 1.1 as assessed by Investigator) [ Time Frame: Through study completion, an average of 2 years ]
the proportion of participants who have a confirmed complete response or confirmed partial response, as determined by the Investigator at local site per RECIST 1.1.
PFS6 (per RECIST 1.1 as assessed by Investigator) [ Time Frame: Through study completion, an average of 2 years ]
the proportion of participants alive and progression-free at 6 months.

Change History

Current Secondary Outcome Measures ^ICMJE

PFS per RECIST 1.1 as assessed by the Investigator [ Time Frame: Through substudy completion, an average of 2 years ]
the time from the start of study intervention until progression per RECIST 1.1 as assessed by the Investigator at the local site or death due to any cause in the absence of progression.
OS [ Time Frame: Through substudy completion, an average of 2 years ]
the time from the start of study intervention until the date of death due to any cause.
other safety related endpoints [ Time Frame: Through substudy completion, an average of 2 years ]
Incidence of AEs, AESIs, and SAEs.
DoR per RECIST 1.1 based on Investigator assessment. [ Time Frame: Through substudy completion, an average of 2 years ]
the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 by the Investigator at local site or death due to any cause in the absence of disease progression.

Original Secondary Outcome Measures ^ICMJE

PFS per RECIST 1.1 as assessed by the Investigator [ Time Frame: Through study completion, an average of 2 years ]
the time from the start of study intervention until progression per RECIST 1.1 as assessed by the Investigator at the local site or death due to any cause in the absence of progression.
OS [ Time Frame: Through study completion, an average of 2 years ]
the time from the start of study intervention until the date of death due to any cause.
other safety related endpoints [ Time Frame: Through study completion, an average of 2 years ]
Incidence of AEs, AESIs, and SAEs

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Official Title ^ICMJE

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

Brief Summary

This is a Phase II, open-label, multi-drug, multi-centre study designed to assess the efficacy, safety, tolerability, pharmacokinetics, and immunogenicity of novel combination therapies in participants with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.

Detailed Description

Approximately 240 participants will be assigned across 6 substudies, with approximately 40 evaluable participants of the confirmed recommend dose by SRC for study intervention in each corresponding substudy.

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Gastric Cancer

Intervention ^ICMJE

Drug: Rilvegostomig
an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion
Drug: Volrustomig
an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion
Drug: FOLFOX
5-fluorouracil 400 mg/m^2 IV, oxaliplatin 85 mg/m^2, leucovorin 400 mg/m^2 (or levoleucovorin 200 mg/m^2 when locally preferred and available), day 1, 5-fluorouracil 1200 mg/m^2 IV 24 h day 1-2
Drug: XELOX
capecitabine 1000 mg/m^2 BID, days 1 to 14, oxaliplatin 130 mg/m^2, day 1
Drug: AZD7789
an anti PD 1 and anti TIM 3 bispecific antibody; IV infusion
Drug: AZD0901
an anti Claudin18.2 ADC; IV infusion
Drug: 5-Fluorouracil
5-FU, IV infusion, Q3W
Drug: Capecitabine
Oral take, Q3W

Study Arms ^ICMJE

Experimental: Substudy 1
Volrustomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
Interventions:
- Drug: Volrustomig
- Drug: FOLFOX
- Drug: XELOX
Experimental: Substudy 2
Rilvegostomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
Interventions:
- Drug: Rilvegostomig
- Drug: FOLFOX
- Drug: XELOX
Experimental: Substudy 3
AZD0901 plus volrustomig and 5-fluorouracil or capecitabine
Interventions:
- Drug: Volrustomig
- Drug: AZD0901
- Drug: 5-Fluorouracil
- Drug: Capecitabine
Experimental: Substudy 4
AZD0901 plus rilvegostomig and 5-fluorouracil or capecitabine
Interventions:
- Drug: Rilvegostomig
- Drug: AZD0901
- Drug: 5-Fluorouracil
- Drug: Capecitabine
Experimental: Substudy 5
AZD7789 plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
Interventions:
- Drug: FOLFOX
- Drug: XELOX
- Drug: AZD7789
Experimental: Substudy 6
AZD0901 plus AZD7789 and 5-fluorouracil or capecitabine
Interventions:
- Drug: AZD7789
- Drug: AZD0901
- Drug: 5-Fluorouracil
- Drug: Capecitabine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

240

Original Estimated Enrollment ^ICMJE

Estimated Study Completion Date ^ICMJE

March 31, 2026

Estimated Primary Completion Date

September 30, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

18 years or older at the time of signing the ICF.
Body weight > 35 kg.
Previously untreated for unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
Has measurable target disease assessed by the Investigator based on RECIST 1.1.
ECOG PS zero or one.
Life expectancy of at least 12 weeks.
Adequate organ and bone marrow function.
Has central lab confirmed Claudin18.2 status at screening from archival tumour collected within past 24 months or from a fresh biopsy when Substudy 3, Substudy 4 or Substudy 6 is open for recruitment.

Exclusion Criteria:

Participants with HER2-positive (3+ by IHC, or 2+ by IHC and positive by in situhybridisation) or indeterminate gastric or GEJ carcinoma.
Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression.
Participants with ascites which cannot be controlled with appropriate interventions.
Active infectious diseases, including tuberculosis, HIV infection, or hepatitis B/C.
Uncontrolled intercurrent illness.
Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment.
History of another primary malignancy.
Previous treatment with an immune-oncology agent.
Previous treatment with any modalities of Claudin18.2 target therapy or MMAE exposure (when Substudy 3, Substudy 4, or Substudy 6 is open for recruitment).

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Listed Location Countries ^ICMJE

China, Japan, Korea, Republic of, Spain, Taiwan, United Kingdom, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT05702229

Other Study ID Numbers ^ICMJE

D7986C00001
2022-002840-29 ( EudraCT Number )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:	Yes
Plan Description:	Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request 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 shared.
Time Frame:	AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria:	When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL:	https://astrazenecagroup-dt.pharmacm.com/DT/Home