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

Part of paid clinical trials in Los Angeles, California.

Sponsor
AstraZeneca
Study ID
NCT05702229
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rilvegostomig — DRUG
    an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion
  • Volrustomig — DRUG
    an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion
  • FOLFOX — DRUG
    5-fluorouracil oxaliplatin, leucovorin (levoleucovorin when locally preferred and available)
  • XELOX — DRUG
    capecitabine and oxaliplatin
  • AZD0901 — DRUG
    an anti Claudin18.2 ADC; IV infusion
  • 5-Fluorouracil — DRUG
    5-FU, IV infusion
  • Capecitabine — DRUG
    Oral take

Study Details

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.

Key Dates

Start date
Jan 16, 2023
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
May 31, 2029

Study Design

Enrollment
163 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Substudy 1
    Volrustomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
  • Experimental: Substudy 2
    Rilvegostomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
  • Experimental: Substudy 3
    AZD0901 plus volrustomig and 5-fluorouracil or capecitabine
  • Experimental: Substudy 4, Cohort 4a1
    Sonesitatug vedotin (AZD0901) plus rilvegostomig and 5-fluorouracil or capecitabine
  • Experimental: Substudy 4, Cohort 4a2
    Sonesitatug vedotin (AZD0901) plus rilvegostomig and 5-fluorouracil
  • Experimental: Substudy 4, Cohort 4b
    Sonesitatug vedotin (AZD0901) plus capecitabine

Primary Outcome Measure

ORR (per RECIST 1.1 as assessed by Investigator) [ Time Frame: Through substudy completion, an average of 2 years ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia90017-
Research SiteLos AngelesCalifornia90095-
Research SiteBaton RougeLouisiana70817-
Research SiteGrand RapidsMichigan49503-
Research SiteNew Hyde ParkNew York11042-
Research SiteNew YorkNew York10028-
Research SiteNew YorkNew York10065-
Research SiteNew YorkNew York11210-
Research SiteShirleyNew York11967-
Research SiteThe BronxNew York10469-
Research SitePittsburghPennsylvania15212-

Find similar trials in Los Angeles, CA

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
Research Site· Los Angeles, CAResearch Site· Baton Rouge, LAResearch Site· Grand Rapids, MIResearch Site· New Hyde Park, NYResearch Site· New York, NYResearch Site· Shirley, NY

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