Innovent Biologics

Biomarkers

• Claudin 18.2 expression5
• EGFR exon 19 deletion / L858R2
• KRAS G12C1
• MSI-H / dMMR1

Drugs in these trials

Targeted, immune and antibody-drug-conjugate therapies named in the company's active biomarker-selected trials (including other companies' drugs used in combination).

IBI343 5sintilimab 4bevacizumab 1limertinib 1osimertinib 1IBI363 1fulzerasib 1cetuximab 1

Upcoming readouts

Active phase 2 and 3 trials whose primary completion date falls in the next 12 months, according to the sponsor.

• 2026-12 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) Phase 3 · Claudin 18.2 expression
• 2027-06 A Multicenter Study of IBI343 Monotherapy Versus Placebo in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, Pancreatic Cancer(G-HOPE-002) Phase 3 · Claudin 18.2 expression
• 2027-06 Study of IBI3005 Combination Therapy in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors Phase 1/2 · EGFR exon 19 deletion / L858R

Trials

9 of 16 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. A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer

   Active, not recruiting Phase 3 Innovent Biologics Started 2023Primary completion 2028-04 NCT05890742

   sintilimab

   MSI-H or dMMR.

   MSI-H / dMMRMSI-H

4. Study of IBI3005 Combination Therapy in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

   Not yet recruiting Phase 1/2 Innovent Biologics Started 2026Primary completion 2027-06 NCT07612137

   IBI3005sintilimabbevacizumablimertinibosimertinib FDA EUcarboplatin

   Tumor harboring EGFR-sensitive mutations (Ex19del or L858R, with or without other EGFR mutations) confirmed via histology or cytology speci…

   EGFR exon 19 deletion / L858RSolid Tumor

5. 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

6. 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

7. A Study of IBI363 Combination Therapy in Participants With Advanced Solid Tumors

   Not yet recruiting Phase 2 Innovent Biologics Started 2025Primary completion 2026-09 NCT07124793

   IBI363

   Documented EGFR mutation (ex19del or L858R) detected in tumor tissue or blood samples;

   EGFR exon 19 deletion / L858REGFR Mutant NSCLC and Platinum Resistant Ovarian Cancer

8. Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation

   Recruiting Phase 1 Innovent Biologics Started 2022Primary completion 2025-05 NCT05504278

   fulzerasibcetuximabpemetrexedcarboplatinsintilimabcisplatin

   Histologically confirmed diagnosis of nonsquamous NSCLC with KRAS G12C mutation

   KRAS G12CAdvanced Non-Small Cell Lung 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

No trials match these filters.