^
    2d
    GISTAR-1: A Multicenter, Open-label Clinical Study to Evaluate the Efficacy and Safety of NB003 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (clinicaltrials.gov)
    P2/3, N=255, Not yet recruiting, Ningbo Newbay Technology Development Co., Ltd
    New P2/3 trial
    |
    KIT (KIT proto-oncogene, receptor tyrosine kinase)
    |
    KIT exon 9 mutation
    |
    Stivarga (regorafenib) • NB003
    3d
    Asingle-arm,open-label,multi-centerclinicalstudyofthecombinationofetotilizumabandanti-angiogenicdrugsand/orchemotherapyassecond-linetreatmentforpatientswithmetastaticcolorectalcancer. (ChiCTR2500113997)
    P=N/A, N=30, Not yet recruiting, Qingdao Traditional Chinese Medicine Hospital; Qingdao Traditional Chinese Medicine Hospital
    New trial
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • capecitabine • Stivarga (regorafenib) • oxaliplatin
    3d
    A study on the efficacy and safety of Toripalimab combined with Regorafenib in the second-line and subsequent treatment of hepatocellular carcinoma previously treated with immunotherapy (ChiCTR2500111736)
    P4, N=35, Not yet recruiting, Yantai Yuhuangding Hospital; Yantai Yuhuangding Hospital
    New P4 trial
    |
    Loqtorzi (toripalimab-tpzi) • Stivarga (regorafenib)
    3d
    Clinical study on the efficacy difference of regorafenib combined with sintilimab in the later-line treatment of left and right-sided colorectal cancer (ChiCTR2500109899)
    P4, N=60, Not yet recruiting, Chongqing University Cancer Hospital; Chongqing University Cancer Hospital
    New P4 trial
    |
    Tyvyt (sintilimab) • Stivarga (regorafenib)
    3d
    Phase IIb Trial of AST-3424 in Patients with AKR1C3-High Expression Advanced Hepatocellular Carcinoma Previously Treated with Immune Checkpoint Inhibitor-Based Therapy (ChiCTR2500114071)
    P2, N=75, Not yet recruiting, Nanjing Tianyi Mountain Hospital; Nanjing Tianyi Mountain Hospital
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1) • AKR1C3 (Aldo-Keto Reductase Family 1 Member C3)
    |
    Stivarga (regorafenib) • OBI-3424
    3d
    MYLK4 promotes colorectal cancer progression by regulating lipid metabolism reprogramming via targeting ferroptosis. (PubMed, Neoplasia)
    Elevated SCD1 levels correlate with increased MYLK4 levels, and their concurrent expression forecasts regorafenib resistance and poor prognosis in colorectal cancer...Patients with colorectal cancer exhibiting elevated MYLK4 activity and wild-type p53 may derive clinical benefits from this combination therapy. These results suggest that MYLK4 may serve as a promising therapeutic target for the treatment of colorectal cancer.
    Journal
    |
    MYLK (Myosin Light Chain Kinase) • SCD (Stearoyl-CoA Desaturase)
    |
    TP53 wild-type
    |
    Stivarga (regorafenib)
    4d
    SNDX-5613-0706: Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid Tumors (clinicaltrials.gov)
    P1/2, N=42, Completed, Syndax Pharmaceuticals | Active, not recruiting --> Completed | Trial completion date: Aug 2027 --> Jun 2025 | Trial primary completion date: Dec 2025 --> Jun 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    Stivarga (regorafenib) • Revuforj (revumenib)
    5d
    A Trial of Regorafenib Plus Lorigerlimab in Patients With Locally Recurrent or Regrowing pMMR/MSS Localized Rectal Cancer (clinicaltrials.gov)
    P2, N=0, Withdrawn, M.D. Anderson Cancer Center | N=20 --> 0 | Trial completion date: Sep 2032 --> Jan 2026 | Initiation date: Apr 2026 --> Oct 2025 | Not yet recruiting --> Withdrawn | Trial primary completion date: Sep 2030 --> Jan 2026
    Enrollment change • Trial completion date • Trial initiation date • Trial withdrawal • Trial primary completion date • pMMR
    |
    MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
    |
    Stivarga (regorafenib) • lorigerlimab (MGD019)
    5d
    Regorafenib, Ipilimumab and Nivolumab for the Treatment of Chemotherapy Resistant Microsatellite Stable Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1, N=39, Completed, City of Hope Medical Center | Active, not recruiting --> Completed
    Trial completion
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF wild-type
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Stivarga (regorafenib)
    5d
    Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy (clinicaltrials.gov)
    P1/2, N=28, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2025 --> Aug 2026
    Trial completion date
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    BRAF wild-type
    |
    Stivarga (regorafenib) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    6d
    A Trial of Regorafenib Plus Lorigerlimab as Neoadjuvant Therapy for Patients With pMMR/MSS, Resectable, Lung-limited Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1/2, N=0, Withdrawn, M.D. Anderson Cancer Center | N=30 --> 0 | Trial completion date: Dec 2032 --> Jan 2026 | Initiation date: Feb 2026 --> Sep 2025 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2030 --> Jan 2026
    Enrollment change • Trial completion date • Trial initiation date • Trial withdrawal • Trial primary completion date • pMMR
    |
    MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
    |
    Stivarga (regorafenib) • lorigerlimab (MGD019)
    6d
    Indirect comparisons of tucatinib in combination with trastuzumab for patients with previously treated HER2-positive metastatic colorectal cancer. (PubMed, J Comp Eff Res)
    Materials & An unanchored, matching-adjusted indirect comparison was conducted following a systematic literature review that identified the CORRECT trial (NCT01103323), which investigated regorafenib, and the RECOURSE trial (NCT01607957), which investigated trifluridine-tipiracil, as comparators for tucatinib in combination with trastuzumab. ORR also favored tucatinib in combination with trastuzumab across analyses. These data support that tucatinib in combination with trastuzumab is an effective therapy option in patients with previously treated mCRC.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Stivarga (regorafenib) • Tukysa (tucatinib) • Lonsurf (trifluridine/tipiracil)