marked.bio

multi-kinase inhibitor · small molecule

regorafenib

10 active trials across 7 of our biomarkers, targeting multi-kinase. Not approved for any biomarker on marked.bio yet.

Also known as BAY 73-4506, Stivarga.

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 5 8 Phase 3
BRAF V600E 3 5 Phase 2
KRAS G12C 2 7 Phase 2
KRAS G12D 2 6 Phase 2
ALK fusion 1 2 Phase 2
NTRK1/2/3 fusion 1 1 Phase 2
ROS1 fusion 1 2 Phase 2

Sponsors

Industry sponsors leading active biomarker-selected trials of regorafenib.

  1. Shanghai JMT-Bio 1
  2. Jiangsu Hengrui 1
  3. Exelixis 1

Trials

10 of 21 trials shown

  1. 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

  2. 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

  3. Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer

    Active, not recruiting Phase 3 Exelixis Started 2022Primary completion 2026-06 NCT05425940

    zanzalintinibatezolizumab FDAregorafenib

    Documented NOT to have microsatellite instability-high (MSI-high) or mismatch repair deficient (dMMR) CRC by tissue-based analysis.

    MSI-H / dMMRColorectal Cancer

  4. STREAM-2: Second-line Treatment With REgorafenib in Advanced RAS-Mutant Colorectal Cancer

    Recruiting Phase 2 National Cancer Institute, Naples Started 2025Primary completion 2026-10 NCT07213570

    standard second line treatment, at discretion of the investigatorregorafenib

    RAS mutant at initial diagnosis assessed at local centers according with a validated method defined …

    KRAS G12CKRAS G12DColorectal Cancer Metastatic

  5. Efficacy And Safety Of Hydroxychloroquine Combined With Methotrexate, Capecitabine And Bevacizumab Vs. Regorafenib In Participants With Refractory Metastatic Colorectal Cancer With Mutations In RAS Genes

    Recruiting Phase 2 Sergey Orlov, MD Started 2025Primary completion 2027-04 NCT06949982

    experimental group x-MAPregorafenib

    Presence of mutations in the KRAS or NRAS gene.

    KRAS G12CKRAS G12DMetastatic Colorectal Cancer (mCRC), Colorectal Neoplasms

  6. 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

  7. KN 046 Plus Regorafenib in MSS Metastatic Colorectal Cancer

    Recruiting Phase 2 Peking University Cancer Hospital & Institute Started 2023Primary completion 2026-12 NCT05985109

    KN046regorafenib

    Cohort B: pMMR/MSS mCRC with BRAF V600E mutation, who failed fluoropyrimidine, oxaliplatin, and irinotecan treatments.

    BRAF V600EStatus may be outdated, last updated 2023-10-26Colorectal Cancer

  8. KN046 Plus Regorafenib or Apatinib in MSI-H Digestive System Cancers Resistant to PD-1/PD-L1 Blockade

    Active, not recruiting Phase 2 Peking University Cancer Hospital & Institute Started 2023Primary completion 2026-12 NCT06099821

    KN046regorafenibapatinib

    dMMR/MSI-H cancers resistant to PD1/PDL1 blockade.

    MSI-H / dMMRDigestive System Cancers

  9. A Clinical Trial of Regorafenib in Patients With Pretreated Advanced Melanoma

    Active, not recruiting Phase 2 Universitair Ziekenhuis Brussel Started 2022Primary completion 2026-12 NCT05370807

    regorafenibTriplet therapy

    Cohort-B and -C: the melanoma must carry a documented BRAFV600 mutation.

    BRAF V600EMelanoma Stage III, Melanoma Stage IV

  10. A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.

    Recruiting Phase 2 Centre Leon Berard Started 2020Primary completion 2026-10 NCT04116541

    siremadlinribociclibcabozantinibalectinibregorafenibtrametinib FDA EUdabrafenib FDA EUAvapritinib

    …r amplification and/or rearrangement of VEGFR1-3, TIE-2, KIT, RET, RAF1, BRAF (other than V600 mutations), CRAF, HRAS, PDGFR, FGFR1-2, FLT3 and/or CSFR1, and/or amplification of the ligands, an…

    BRAF V600EALK fusionROS1 fusionNTRK1/2/3 fusionMalignant Solid Tumor