Ivonescimab in Comb. With FOLFOX in Advanced HER2 Neg. GEA

Part of paid clinical trials in Santa Monica, California.

Sponsor
Massachusetts General Hospital
Study ID
NCT07070466
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Ivonescimab — DRUG
    Humanized immunoglobulin G1 monoclonal antibody
  • 5-Fluorouracil — DRUG
    Nucleoside metabolic inhibitor
  • Oxaliplatin — DRUG
    Platinum-based drug and organoplatinum complex
  • Leucovorin — DRUG
    5-formyl derivative of tetrahydrofolic acid

Study Details

This is a single arm, open-label, phase II trial investigating the combination of ivonescimab with standard FOLFOX chemotherapy in 1L therapy for HER2- GEA.

Key Dates

Start date
Oct 10, 2025
Status verified
Mar 2026
Primary completion
Dec 1, 2026
Completion
Sep 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ivonescimab plus FOLFOX
    Ivonescimab will be given once every 2 weeks into your vein (by intravenous infusion) over about 60 minutes. For the first treatment ivonescimab will be given alone with no chemotherapy. FOLFOX is a combination of 5-fluorouracil, oxaliplatin, and leucovorin. Starting Cycle 2 on beyond FOLFOX will be given after ivonescimab once every 2 weeks into your vein (intravenously). Some may be given over a shorter period of time (as short as approximately 1 minute) and others up to approximately 120 minutes. Ivonescimab in combination with FOLFOX will be given for up to 2 years as long as no serious side effects and disease does not worsen.

Primary Outcome Measure

6-month progression free survival rate [ Time Frame: From the start of treatment (Cycle 1, day 1) to first documented disease progression or date of death from any cause. Status at 6-months after starting treatment will be reported. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UCLASanta MonicaCalifornia90404
Zev A. Wainberg, MD
[email protected]
310-829-5471
Massachusetts General HospitalBostonMassachusetts02114
Samuel Klempner, MD
[email protected]
617-724-4000

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