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)

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 192 studies on the registry; 44 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Study arms

• Active comparator
  Active Comparator: control arm

  There are three drugs ( irinotecan, paclitaxel,or FTD/TPI (only are applicable in US/EU/Japan and other regions where FTD/TPI is approved for GC treatment)) in active contral arm, the subjects will receive the drug based on investigator's choice

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

• Experimental
  IBI343 monotherapy

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

  Drug: IBI343

Interventions

• DrugIrinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI）

  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).

• DrugIBI343

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

  Also known as: Arcotatug Tavatecan

Primary outcomes

1. progression free survival(PFS)

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

   Time frame: within approximately 20 months

2. overall survival(OS)

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

   Time frame: within approximately 26 months

Secondary outcomes

1. Objective response rate (ORR)

   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.

   Time frame: within approximately 20 months

2. disease control rate (DCR)

   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.

   Time frame: within approximately 20 months

3. duration of response (DoR)

   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.

   Time frame: within approximately 20 months

4. time to response (TTR)

   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.

   Time frame: within approximately 20 months

5. area under the curve (AUC)

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

   Time frame: within approximately 20 months

6. maximum concentration (Cmax)

   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.

   Time frame: within approximately 20 months

7. time to maximum concentration(Tmax)

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

   Time frame: within approximately 20 months

8. trough concentration (Ctrough)

   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.

   Time frame: within approximately 20 months

9. clearance (CL)

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

   Time frame: within approximately 20 months

10. volume of distribution (V)

    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.

    Time frame: within approximately 20 months

11. Incidence of anti-drug antibody (ADA)

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

    Time frame: within approximately 20 months

12. neutralizing antibody (NAb)

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

    Time frame: within approximately 20 months

Individual participant data

Plan to share: No