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NCT Number: NCT06238843

A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma (G-HOPE-001)

This is a Multicenter, Randomized, Open-label, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects with Previously Treated Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma to compare the progression free survival (PFS) and overall survival (OS)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able and willing to sign a written Informed Consent Form(ICF) and to comply with protocol-specified visits and related procedures.
  • Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC).
  • Has received and progressed on at least 2 lines of systemic therapy (anti-PD-(L)1 in combination with platinum or fluoropyrimidines, paclitaxel/docetaxel, irinotecan). A prior (neo)adjuvant systemic therapy that ended within 6 months prior to disease relapse is defined as the first line therapy. The subject has ≤ 4 prior lines of systemic therapy.
  • Has histopathologically confirmed CLDN18.2-positive disease.
  • Is a man or woman of 18 years of age or older at the time of signing the ICF.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

Exclusion criteria

  • Has HER2-positive (defined as immunohistochemistry [IHC] 3+, or IHC 2+ and positive by in situ hybridization) disease.
  • Is currently participating in another interventional clinical study, except when the subject is during survival follow-up of an interventional clinical study.
  • Has a history of treatment with topoisomerase inhibitorbased antibody-drug conjugate(s).
  • Has received the last dose of an anti-cancer therapy (including traditional Chinese medicine indicated for gastric cancer in the package insert, but excluding herbal prescriptions) within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study treatment.
  • Plans to receive other anti-cancer therapy during treatment with the study drug (palliative radiotherapy for symptomatic (e.g., pain) relief that does not affect response assessment is allowed).

Treatment and study plan

Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI）

Drug

Drugs: Irinotecan Subjects in the control arm will receive irnotecan 150mg/m2 IV D1, D15, Q4W in 4-weeks cycles.

Drugs: Paclitaxel Subjects in the control arm will receive paclitaxel 80mg/m2 IV D1, D8, D15, Q4W in 4-week cycles, Drugs:FTD/TPI Subjects in the control arm will receive FTD/TPI 35 mg/m2 up to a maximum of 80 mg orally twice a day on Days 1 to 5 and Days 8 to 12, Q4W (applicable in US/EU/Japan and other regions where FTD/TPI is approved for GC treatment).

IBI343

Drug

Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycles .

Other names: Arcotatug Tavatecan

Primary outcomes

  1. progression free survival(PFS)

    Time frame: within approximately 20 months

    Progression-free survival (PFS) is defined as the time from random assignment in the trial to disease progression or death from any cause.

  2. overall survival(OS)

    Time frame: within approximately 26 months

    Overall survival (OS) is defined as the time from randomization to death from any cause.

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: within approximately 20 months

    ORR is defined as the proportion of subjects in the analysis population who achieve confirmed objective response (CR or PR) as assessed by the IRRC per RECIST v1.1.

  2. disease control rate (DCR)

    Time frame: within approximately 20 months

    DCR is defined as the proportion of subjects in the analysis population who achieve disease control (CR, PR, or SD) as determined by the IRRC per RECIST v1.1 criteria.

  3. duration of response (DoR)

    Time frame: within approximately 20 months

    DoR is defined as the time from the first CR or PR to disease progression or death from any cause, whichever occurs first for subjects with ORR as assessed by IRRC per RECIST v1.1 criteria.

  4. time to response (TTR)

    Time frame: within approximately 20 months

    TTR is defined as the time from randomization to the first CR or PR for subjects with ORR as assessed by IRRC per RECIST v1.1 criteria.

  5. area under the curve (AUC)

    Time frame: within approximately 20 months

    Area under the curve (AUC) is defined as the area under the plasma concentration versus time curve.

  6. maximum concentration (Cmax)

    Time frame: within approximately 20 months

    Cmax is the highest concentration of a drug in the blood after the drug has been administered and before the administration of a second dose.

  7. time to maximum concentration(Tmax)

    Time frame: within approximately 20 months

    The time it takes for a drug to reach the maximum concentration (Cmax) after administration of the drug

  8. trough concentration (Ctrough)

    Time frame: within approximately 20 months

    Ctrough is the lowest concentration of a drug in the blood after the drug has been administered and before the administration of a second dose.

  9. clearance (CL)

    Time frame: within approximately 20 months

    The clearance is defined as the plasma volume in the vascular compartment that is cleared of drug per unit of time.

  10. volume of distribution (V)

    Time frame: within approximately 20 months

    Volume of distribution (Vd) is defined as the arrangement or rate of incidence of a drug in the body in relation to the measured plasma concentration.

  11. Incidence of anti-drug antibody (ADA)

    Time frame: within approximately 20 months

    Incidence of anti-drug antibody (ADA) is defined as the sum of both treatmentinduced (post-baseline ADA-positive only) and treatment-boosted ADA.

  12. neutralizing antibody (NAb)

    Time frame: within approximately 20 months

    Neutralizing antibodies (NAb) are a subset of binding ADA that bind to the drug and inhibit its pharmacological function by preventing target binding.

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Open-label, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Acronym: G-HOPE-001

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 2, 2024
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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