ivonescimab

Biomarkers

Sponsors

Industry sponsors leading active biomarker-selected trials of ivonescimab.

1. Summit Therapeutics 1
2. Akeso 1
3. Multitude Therapeutics 1
4. MediLink Therapeutics 1
5. Revolution Medicines 1

Trials

17 of 18 trials shown

1. Phase III Study of AK112 for NSCLC Patients

   Active, not recruiting Phase 3 Summit Therapeutics Started 2023Primary completion 2025-04 NCT06396065

   ivonescimabpemetrexedcarboplatin

   …tumor histology or cytology or blood test before enrollment (eg, exon 18 point mutations, exon 19 deletions, exon 20 point mutations, and exon 21 point mutations).

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

2. Phase 3 Clinical Study of AK112 for NSCLC Patients

   Active, not recruiting Phase 3 Akeso Started 2022Primary completion 2023-03 NCT05184712

   ivonescimabpemetrexedcarboplatin

   The tumor histology, cytology or hematology confirmed the presence of EGFR activating mutations before enrollment

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

3. Ivonescimab Alone And With Carboplatin/Pemetrexed For NSCLC

   Recruiting Phase 2 Massachusetts General Hospital Started 2026Primary completion 2028-03 NCT07405190

   ivonescimabcarboplatinpemetrexed

   …vonescimab monotherapy: Tumor harboring classical EGFR sensitizing mutation (i.e., L858R, exon 19 deletion), or ALK, ROS1, RET, or NTRK1-3 fusion, per local testing.

   EGFR exon 19 deletion / L858RALK fusionROS1 fusionLung Cancer (NSCLC), Lung Cancer Non-Small Cell Cancer (NSCLC), Lung Cancer (Non-Small Cell), Lung Cancer - Non Small Cell

4. A Phase II Clinical Trial of Ivonescimab Plus Third-generation EGFR-TKIs in Advanced Non-small Cell Lung Cancer With Gradual or Potential Progression After EGFR-TKIs Treatment

   Active, not recruiting Phase 2 Shandong Cancer Hospital and Institute Started 2026Primary completion 2028-01 NCT07669051

   ivonescimab

   …testing before enrollment, including exon 19 deletion (19Del) and exon 21 point mutation (L858R)

   EGFR exon 19 deletion / L858RNSCLC (Advanced Non-small Cell Lung Cancer)

5. AMT-116 in Combination With AK112 in Patients With Lung Cancer

   Recruiting Phase 1/2 Multitude Therapeutics Started 2026Primary completion 2027-05 NCT07590531

   AMT-116ivonescimab

   …ort 3: Histologically or cytologically diagnosed with non-squamous NSCLC and harboring an EGFR mutation.

   EGFR exon 19 deletion / L858RAdvanced Non-small Cell Lung Cancer (NSCLC)

6. A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer

   Recruiting Phase 1/2 Memorial Sloan Kettering Cancer Center Started 2026Primary completion 2028-04 NCT07535437

   ivonescimabdatopotamab deruxtecan FDAosimertinib FDA EU

   A Phase 1/2 Trial of Ivonescimab With Dato-DXd or Osimertinib in Patients With Metastatic EGFR-mutant Non-small Cell Lung Cancer That Progressed on EGFR TKI Therapy

   EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

7. Glecirasib Combined With Ivonescimab for First-line Treatment of KRAS G12C-mutated NSCLC

   Not yet recruiting Phase 1/2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2026Primary completion 2027-09 NCT07339839

   glecirasibivonescimab

   KRAS G12C mutation confirmed by validated testing.

   KRAS G12CNSCLC Stage IV, KRAS G12C

8. Phase II Neoadjuvant Study of Garsorasib Followed by Ivonescimab Plus Chemotherapy in Resectable Stage IIA-IIIB KRAS G12C-Mutant NSCLC (GIVEN Study)

   Recruiting Phase 2 Guangdong Provincial People's Hospital Started 2026Primary completion 2027-12 NCT07472478

   garsorasibivonescimab

   Mutation Status: KRAS G12C mutation positivity must be confirmed by next-generation sequencing (NGS) or polymerase c…

   KRAS G12CLung Cancer (NSCLC), KRAS G12C Lung Cancer

9. Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors

   Recruiting Phase 1/2 Revolution Medicines Started 2026Primary completion 2029-05 NCT07397338

   daraxonrasibelironrasibzoldonrasibivonescimabcarboplatincisplatinpemetrexedcetuximab

   …ogically confirmed, locally advanced or metastatic solid tumor malignancy with documented RAS mutation in KRAS, HRAS, or NRAS.

   KRAS G12CKRAS G12DAdvanced Solid Tumors, Metastatic Solid Tumors, Non-small Cell Lung Cancer (NSCLC), NSCLC

10. Ivosidenib Plus mFOLFOXIRI and Celecoxib for BRAF-targeted Therapy-refractory BRAF V600E-mutant Colorectal Cancer Patients

    Recruiting Phase 2 Sun Yat-sen University Started 2026Primary completion 2027-12 NCT07809893

    ivonescimaboxaliplatinirinotecanfluorouracilleucovorin

    Genetic testing indicates a BRAF V600E mutation;

    BRAF V600EColorectal Cancer

11. Trastuzumab Deruxtecan Plus ivonescImab for Hormone Receptor-positive HER2 Negative Advanced Breast Cancer Study

    Recruiting Phase 2 Fudan University Started 2026Primary completion 2027-12 NCT07647016

    trastuzumab deruxtecan FDA EUivonescimab

    …y confirmed Hormone Receptor-positive (HR+) and Human Epidermal Growth Factor Receptor 2 (HER2)-low or HER2-ultralow breast cancer, with evidence of locally recurrent or metastatic disease …

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Breast Cancer

12. A Study of YL201 and Ivonescimab (AK112) in Advanced Solid Tumors

    Recruiting Phase 1/2 MediLink Therapeutics Started 2025Primary completion 2027-01 NCT07208773

    YL201ivonescimab

    Phase 2: Extensive-stage SCLC, Non-AGA NSCLC, EGFR mutation NSCLC.

    EGFR exon 19 deletion / L858RAdvanced Solid Tumors, Non Small Cell Lung Cancer, Small Cell Lung Cancer

13. A Multicenter, Single-arm Phase II Study to Evaluate the Efficacy and Safety of Fulzerasib (IBI351) in Combination With Ivonescimab (AK-112) in First-line Treatment of Advanced or Metastatic Non-small Cell Lung Cancer Patients With KRAS G12C Mutation

    Not yet recruiting Phase 2 Shanghai Chest Hospital Started 2025Primary completion 2027-04 NCT06936644

    fulzerasibivonescimab

    All subjects must have a written test report before enrollment to prove the presence of KRAS G12C mutation

    KRAS G12CKRAS G12C Lung Cancer

14. Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric/Gastroesophageal Adenocarcinoma

    Recruiting Phase 2 UNICANCER Started 2025Primary completion 2027-09 NCT06846346

    ivonescimabFOLFOXoxaliplatinleucovorinfluorouracilirinotecanpaclitaxel

    …east one of the following actionable biomarker (PD-L1 CPS≥1, and/or HER2-positive, and/or Claudin 18.2-positive), who had received only one prior line of treatment for advanced disease (cohort…

    Claudin 18.2 expressionMetastatic Esophageal Adenocarcinoma, Advanced Esophageal Adenocarcinoma, Metastatic Gastric Adenocarcinoma, Advanced Gastric Adenocarcinoma

15. Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer

    Recruiting Phase 2 M.D. Anderson Cancer Center Started 2025Primary completion 2028-07 NCT06959550

    ivonescimab

    Cohort 1: MSI-H/dMMR: ICI-refractory

    MSI-H / dMMRMetastatic Colorectal Cancer

16. A Study of Tepotinib and Ivonescimab in People With Non-Small Cell Lung Cancer

    Recruiting Phase 1 Memorial Sloan Kettering Cancer Center Started 2026Primary completion 2029-05 NCT07619339

    tepotinib FDA EUivonescimab

    Patients must have documentation of MET exon 14 skipping present in their cancer using an FDA-approved assay done within a laboratory wit…

    MET exon 14 skippingNon-Small Cell Lung Cancer

17. Ivonescimab Combined With Chemotherapy for the Treatment of Leptomeningeal Metastases Failed to EGFR-TKIs

    Not yet recruiting No phase Jiangsu Province Nanjing Brain Hospital Started 2025Primary completion 2025-10 NCT06766591

    ivonescimab

    EGFR mutation NSCLC

    EGFR exon 19 deletion / L858RNSCLC, Chemotherapy, Leptomeningeal Metastases, EGFR-TKI

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