marked.bio

VEGFR TKI · small molecule

fruquintinib

11 active trials across 8 of our biomarkers, targeting VEGFR1-3. Not approved for any biomarker on marked.bio yet.

Also known as HMPL-013, Fruzaqla.

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
MSI-H / dMMR 6 7 Phase 3
BRAF V600E 2 2 Phase 2
BRCA1/2 mutation 2 3 Phase 1/2
KRAS G12C 2 5 Phase 3
KRAS G12D 2 5 Phase 3
Claudin 18.2 expression 1 1 Phase 3
ALK fusion 0 1 –
EGFR exon 19 deletion / L858R 0 3 –

Sponsors

Industry sponsors leading active biomarker-selected trials of fruquintinib.

  1. Immunitas Therapeutics 1
  2. Sapience Therapeutics 1
  3. Shanghai JMT-Bio 1
  4. Jiangsu Hengrui 1

Trials

11 of 19 trials shown

  1. Fruquintinib Versus Bevacizumab Plus Chemotherapy in Second-Line RAS-Mutant Metastatic Colorectal Cancer (FRU-RAS)

    Not yet recruiting Phase 3 Fudan University Started 2026Primary completion 2028-12 NCT07362836

    fruquintinibbevacizumab

    RAS mutant type.

    KRAS G12CKRAS G12DColorectal Cancer

  2. JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan

    Not yet recruiting Phase 3 Shanghai JMT-Bio Started 2026Primary completion 2027-11 NCT07384377

    JSKN003trifluridine/tipiracilregorafenibfruquintinib

    …reatment with oxaliplatin, 5-fluorouracil (such as 5-FU, Capecitabine) , irinotecan (DMMR/MSI-H subjects also need anti-PD-1/PD-L1 antibody treatment failure).

    MSI-H / dMMRHER2-positive Colorectal Cancer

  3. Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma

    Recruiting Phase 3 Federation Francophone de Cancerologie Digestive Started 2025Primary completion 2030-11 NCT07270991

    trifluridine/tipiracilfruquintinib

    …or taxane (+/- anti-HER2 agents +/- immune checkpoint inhibitors +/- ramucirumab +/- anti-claudin 18.2).

    Claudin 18.2 expressionMetastatic Oesogastric Adenocarcinoma

  4. Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan

    Active, not recruiting Phase 3 Jiangsu Hengrui Started 2024Primary completion 2026-04 NCT06199973

    trastuzumab rezetecantrifluridine/tipiracilregorafenibfruquintinib

    …reatment with oxaliplatin, 5-fluorouracil (such as 5-FU, Capecitabine) , irinotecan (DMMR/MSI-H subjects also need anti-PD-1/PD-L1 antibody treatment failure) ;

    MSI-H / dMMRAdvanced Colorectal Cancer

  5. Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer

    Recruiting Phase 2 The Methodist Hospital Research Institute Started 2026Primary completion 2028-12 NCT07042685

    fruquintinib

    …arkers such as microsatellite instability-high (MSI-H) or B-Raf proto-oncogene mutations (BRAF mutations).

    BRAF V600EMSI-H / dMMRMetastatic Colorectal Cancer (CRC)

  6. A Single-arm, Multicenter Clinical Study of Fruquintinib Combined With Serplulimab and Chemotherapy as First-line Treatment for Patients With RAS/BRAF-mutated Advanced Colorectal Cance

    Not yet recruiting Phase 2 Jiangsu Cancer Institute & Hospital Started 2026Primary completion 2027-12 NCT07622550

    serplulimabfruquintinibXELOX

    Confirmed RAS/BRAF mutation by testing.

    BRAF V600EMetastatic Colorectal Cancer (CRC)

  7. Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal Cancer

    Recruiting Phase 2 Barbara Ann Karmanos Cancer Institute Started 2025Primary completion 2028-04 NCT07130903

    fruquintinib

    …AS (Rat sarcoma mutation), BRAF (B-Raf proto-oncogene, Serine/threonine kinase), MSI/MMR (microsatellite instability, mismatch repair) , and HER2 (Human epidermal growth factor receptor 2) status.

    MSI-H / dMMRMetastatic Colorectal Adenocarcinoma

  8. Phase Ⅱ Clinical Trial of Cadonilimab Combined With Anti-angiogenic Agents in Metastatic dMMR/MSI-H CRC

    Recruiting Phase 2 Fudan University Started 2025Primary completion 2027-05 NCT07003022

    cadonilimabbevacizumabregorafenibfruquintinib

    Age 18-80 years. dMMR or MSI-H Diagnosis confirmed by histological examination and/or cytological examination combined w…

    MSI-H / dMMRColo-rectal Cancer, MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers

  9. Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas

    Active, not recruiting Phase 1/2 Immunitas Therapeutics Started 2022Primary completion 2026-01 NCT05565417

    IMT-009fruquintinib

    a PARPi for patients with gBRCA mutations

    BRCA1/2 mutationMSI-H / dMMRNon Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Triple Negative Breast Cancer, Cutaneous Squamous Cell Carcinoma

  10. A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors

    Active, not recruiting Phase 1 Sapience Therapeutics Started 2023Primary completion 2026-12 NCT05848739

    ST316FOLFIRIbevacizumab FDA EUfruquintinibtrifluridine/tipiracil

    Subjects with TNBC or OC with known BRCA mutations must have been previously treated with or intolerant to Food and Drug Administration (FDA…

    BRCA1/2 mutationColon Cancer, Metastatic Colon Cancer

  11. An Exploratory Clinical Study Evaluating the Efficacy and Safety of Tunlametinib Combined With Fruquintinib in the Third-line Treatment of Advanced Colorectal Cancer Patients With RAS Mutations.

    Not yet recruiting No phase Liu Huang Started 2025Primary completion 2028-04 NCT06985316

    fruquintinib

    4)Previous gene testing results indicate positive RAS mutation

    KRAS G12CKRAS G12DCRC, Colorectal Cancer