Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
I-Mab Biopharma US Limited
Study ID
NCT07432295
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Cancer
  • Esophageal Adenocarcinoma
  • Gastric Cancer
  • Gastroesophageal Junction Carcinoma
  • Metastatic Cancer
  • Solid Tumor

Eligibility Criteria

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

Interventions

  • Givastomig — DRUG
    Givastomig 8mg/kg Q2W IV or 12mg/kg Q3W IV
  • Nivolumab — DRUG
    Q2 or Q3W IV
  • 5Fluorouracil — DRUG
    Q2W IV
  • Leucovorin — DRUG
    Q2W IV
  • Oxaliplatin — DRUG
    Q2W or Q3W IV
  • Capecitabine — DRUG
    Twice daily x 14 days every 3 weeks PO

Study Details

The goal of this clinical trial is to learn if givastomig in combination with standard therapy works to treat adults with cancer in the stomach and/or esophagus (GEA adenocarcinoma). It will also help the researchers to learn more about the safety of givastomig. The main questions it aims to answer are: * Does the addition of givastomig to standard therapy increase the amount of time that participants survive without progression of their cancer? * What toxicities do participants experience when taking givastomig? Participants may be able to take part in the study if they have unresectable or metastatic GEA and if their cancer cells express certain proteins called Claudin 18.2 (CLDN18.2) and PD-L1. Participants whose cancer cells express a protein called HER2 cannot take part. Up to 180 participants will be randomly assigned to received givastomig at one of two doses in combination with an immunotherapy medicine called nivolumab and chemotherapy OR to receive nivolumab and chemotherapy alone. These therapies will be given primarily via intravenous (into a vein) infusion every 2 or 3 weeks. Participants will: * Visit the study treatment center for infusions and/or check-ups and tests every 1-3 weeks * Report any changes in their symptoms to their study doctors * Have scans to check for any changes in their cancer every 8-12 weeks

Key Dates

Start date
Feb 11, 2026
Status verified
May 2026
Primary completion
Mar 31, 2030
Completion
Aug 31, 2030

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Givastomig Arm 1 Combination
    Givastomig (IV) 8 mg/kg every 2 weeks (Q2W) in combination with nivolumab and modified FOLFOX (mFOLFOX) or Givastomig 12 mg/kg every 3 weeks (Q3W) in combination with nivolumab and CAPOX
  • Experimental: Experimental: Givastomig Arm 2 Combination
    Givastomig (IV) 12 mg/kg every 2 weeks (Q2W) in combination with nivolumab and modified FOLFOX (mFOLFOX) or Givastomig 18 mg/kg every 3 weeks (Q3W) in combination with nivolumab and CAPOX
  • Active Comparator: Control: Nivolumab Plus Chemotherapy
    Nivolumab in combination with modified FOLFOX (mFOLFOX) or CAPOX

Primary Outcome Measure

Progression-Free Survival (PFS), BICR-assessed [ Time Frame: Up to 5 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
I-Mab Site 1016GoodyearArizona85338
I-Mab PI - 1016
I-MAB Site 1005DuarteCalifornia91010
I-MAB PI - 1005
I-Mab Site 1002BostonMassachusetts02114
I-Mab PI - 1002

Find similar trials in Goodyear, AZ

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
I-Mab· Goodyear, AZI-MAB· Duarte, CAI-Mab· Boston, MA

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