Kelun-Biotech

Biomarkers

• Claudin 18.2 expression2
• RET fusion or mutation1

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).

sacituzumab tirumotecan 5osimertinib 2tislelizumab 1KL-A167 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 Study of KL590586 in Patients With Advanced Solid Tumors Phase 1/2 · RET fusion or mutation
• 2027-05 A Study of SKB264 in Combination With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Phase 3 · EGFR exon 19 deletion / L858R
• 2027-08 Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer Phase 2 · EGFR exon 19 deletion / L858R

Trials

8 of 8 trials shown

1. A Study of SKB264 in Combination With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

   Active, not recruiting Phase 3 Kelun-Biotech Started 2024Primary completion 2027-05 NCT06670196

   sacituzumab tirumotecanosimertinib FDA EU

   …on With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

   EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

2. A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients

   Active, not recruiting Phase 3 Kelun-Biotech Started 2023Primary completion 2024-07 NCT05870319

   sacituzumab tirumotecanpemetrexedcarboplatincisplatin

   A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients

   EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer

3. Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

   Recruiting Phase 2 Kelun-Biotech Started 2026Primary completion 2027-08 NCT07329322

   sacituzumab tirumotecanosimertinib FDA EU

   Confirmed by tumor histology, or cytology to have EGFR sensitizing mutations.

   EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

4. A Phase II Study of SKB264 + SKB118 in Nsq-NSCLC After EGFR-TKI Failure

   Not yet recruiting Phase 2 Kelun-Biotech Started 2026Primary completion 2027-12 NCT07854509

   sacituzumab tirumotecan

   Confirmed EGFR-sensitizing mutations.

   EGFR exon 19 deletion / L858RNon-Squamous Non-Small Cell Lung Cancer

5. SKB315 in Combination Therapy in Patients With Advanced or Metastatic GC/ GEJ Adenocarcinoma

   Not yet recruiting Phase 2 Kelun-Biotech Started 2026Primary completion 2028-06 NCT07609667

   tislelizumabSKB315 for injectioncapecitabine

   …r tissue slides for immunohistochemistry (IHC) assessment, and advanced solid tumors with Claudin 18.2 and PD-L1 expression as determined by IHC;

   Claudin 18.2 expressionGastroesophageal Junction Adenocarcinoma

6. SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.

   Recruiting Phase 2 Kelun-Biotech Started 2022Primary completion 2026-08 NCT05351788

   sacituzumab tirumotecanKL-A167carboplatincisplatin

   Cohort 3: Patients with locally advanced/metastatic NSCLC with EGFR activating mutation and negative ALK fusion gene, who have failed previous treatment with EGFR-TKIs.

   EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer

7. A Study of KL590586 in Patients With Advanced Solid Tumors

   Active, not recruiting Phase 1/2 Kelun-Biotech Started 2021Primary completion 2026-12 NCT05265091

   KL590586 Capsule

   …cs And Effectiveness Of KL590586 Capsules In Patients With Advanced Solid Tumors Carrying RET Fusion Or Mutant Genes

   RET fusion or mutationAdvanced Solid Tumor

8. A Study of SKB315 in Patients With Advanced Solid Tumors

   Recruiting Phase 1 Kelun-Biotech Started 2022Primary completion 2026-06 NCT05367635

   SKB315 for injectioncapecitabine

   …r tissue slides for immunohistochemistry (IHC) assessment, and advanced solid tumors with Claudin 18.2 expression as determined by IHC

   Claudin 18.2 expressionAdvanced Solid Tumors

No trials match these filters.