CLDN18.2 ADC · ADC

IBI343

9 active trials, targeting Claudin 18.2. Not approved for any biomarker on marked.bio yet.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
Claudin 18.2 expression 9 10 Phase 3

Sponsors

Industry sponsors leading active biomarker-selected trials of IBI343.

  1. Innovent Biologics 5

Trials

Status

9 of 10 trials shown

  1. A Multicenter Study of IBI343 Monotherapy Versus Placebo in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, Pancreatic Cancer(G-HOPE-002)

    Recruiting Phase 3 Innovent Biologics Started 2025Primary completion 2027-06 NCT07066098

    IBI343

    Confirmed as CLDN18.2 positive.

    Claudin 18.2 expressionPancreatic Cancer

  2. 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)

    Active, not recruiting Phase 3 Innovent Biologics Started 2024Primary completion 2026-12 NCT06238843

    irinotecanpaclitaxeltrifluridine/tipiracilIBI343

    Has histopathologically confirmed CLDN18.2-positive disease.

    Claudin 18.2 expressionUnresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

  3. IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

    Recruiting Phase 2 Innovent Biologics Started 2026Primary completion 2030-06 NCT07483567

    IBI343sintilimaboxaliplatin

    Confirmed CLDN18.2 expression by central laboratory pathological tissue testing.

    Claudin 18.2 expressionCLDN18.2 Positive, Primary Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

  4. IBI343 in Combination Therapy for Advanced Malignant Solid Tumors

    Recruiting Phase 2 Innovent Biologics Started 2026Primary completion 2028-03 NCT07483554

    IBI343gemcitabinenab-paclitaxel

    Confirmed CLDN18.2 positive by central laboratory pathological tissue testing.

    Claudin 18.2 expressionCLDN18.2 Positive, Gastric/Gastroesophageal Junction Adenocarcinoma, Pancreatic Ductal Adenocarcinoma

  5. IBI343 Combined With Chemotherapy as Neoadjuvant Therapy in Borderline Resectable Pancreatic Cancer

    Not yet recruiting Phase 2 Zhejiang University Started 2026Primary completion 2028-12 NCT07415525

    IBI343

    (11)Confirmed \*CLDN18.2 positivity by pathological tissue testing. \*CLDN18.2 positivity is defined as Claudin18.…

    Claudin 18.2 expressionPancreatic Cancer, Borderline Resectable Pancreatic Adenocarcinoma

  6. IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer

    Recruiting Phase 1/2 Zhejiang Cancer Hospital Started 2025Primary completion 2027-06 NCT07692750

    IBI343capecitabineoxaliplatin

    The histopathological test confirmed that \*CLDN18.2 was positive.For subjects who have previously received any anti-CLDN18.2 treatment, tumor…

    Claudin 18.2 expressionAdvanced Pancreatic Cancer

  7. IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer

    Recruiting Phase 2 Zhejiang University Started 2025Primary completion 2027-01 NCT06770439

    IBI343gemcitabinenab-paclitaxel

    Pathological tissue testing was confirmed as CLDN18.2 positive.

    Claudin 18.2 expressionAdvanced Pancreatic Cancers

  8. IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer

    Recruiting Phase 1/2 Ruijin Hospital Started 2025Primary completion 2027-07 NCT07025889

    IBI343sintilimaboxaliplatinS-1

    Has histopathologically confirmed CLDN18.2-positive disease. 6.

    Claudin 18.2 expressionGastric Cancer

  9. A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors

    Recruiting Phase 1 Innovent Biologics Started 2022Primary completion 2027-06 NCT05458219

    IBI343FOLFIRINOXmFOLFIRINOXmFOLFOX

    …dies, ADCs, CAR-T, etc.), tumor samples should be obtained post anti-CLDN18.2 therapy for CLDN18.2 expression evaluation.

    Claudin 18.2 expressionLocally Advanced Unresectable or Metastatic Solid Tumors