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    DRUG CLASS:

    DKK1 protein inhibitor

    Related drugs:
    26d
    Phase 2 Study Evaluating the Efficacy of the Combination of DKN-01 (DKK1 Inhibitor, Leap Therapeutics) and Pembrolizumab in the Treatment of Advanced or Recurrent Endometrial Cancer (clinicaltrials.gov)
    P2, N=8, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=60 --> 8
    Enrollment closed • Enrollment change
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    CTNNB1 (Catenin (cadherin-associated protein), beta 1) • AXIN1 (Axin 1) • RSPO2 (R-Spondin 2) • ZNRF3 (Zinc And Ring Finger 3)
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    Keytruda (pembrolizumab) • sirexatamab (DKN-01)
    2ms
    DisTinGuish: A Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy in Patients With Gastric or Gastroesophageal Cancer (clinicaltrials.gov)
    P2, N=247, Terminated, Leap Therapeutics, Inc. | Trial completion date: Dec 2025 --> Mar 2025 | Active, not recruiting --> Terminated; experimental treatment will not be more efficacious than its comparator in the primary endpoint of PFS
    Trial completion date • Trial termination
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    PD-L1 (Programmed death ligand 1) • DKK1 (dickkopf WNT signaling pathway inhibitor 1)
    |
    5-fluorouracil • Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • leucovorin calcium • sirexatamab (DKN-01)
    4ms
    DeFianCe: Phase 2 Study of DKN-01 in Colorectal Cancer (clinicaltrials.gov)
    P2, N=188, Completed, Leap Therapeutics, Inc. | Active, not recruiting --> Completed | Trial completion date: Oct 2025 --> Jul 2025 | Trial primary completion date: Oct 2025 --> Jul 2025
    Trial completion • Trial completion date • Trial primary completion date
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    Avastin (bevacizumab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • sirexatamab (DKN-01)
    5ms
    DKN-01 and tislelizumab as second-line therapy in DKK1-high gastroesophageal adenocarcinoma: DisTinGuish trial part B. (PubMed, Nat Commun)
    The median OS was 8.2 months, median PFS 1.4 months, and DCR rate 34.8% in the overall population. Although exploratory, the results of this trial compare favorably against second-line benchmarks of Keynote-061 and RAINBOW and support the safety and tolerability of DKN-01 combined with tislelizumab.
    Journal • PD(L)-1 Biomarker • IO biomarker
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    DKK1 (dickkopf WNT signaling pathway inhibitor 1)
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    Tevimbra (tislelizumab-jsgr) • sirexatamab (DKN-01)
    5ms
    A Phase 2 Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy in Patients With Colorectal Cancer (clinicaltrials.gov)
    P2, N=60, Recruiting, Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    capecitabine • oxaliplatin
    8ms
    WaKING: Wnt and checKpoint INhibition in Gastric Cancer (clinicaltrials.gov)
    P1/2, N=52, Active, not recruiting, Royal Marsden NHS Foundation Trust | Trial completion date: Sep 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Mar 2025
    Trial completion date • Trial primary completion date • Checkpoint inhibition • Mismatch repair • pMMR
    |
    HER-2 positive
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    Tecentriq (atezolizumab) • sirexatamab (DKN-01)
    9ms
    A Phase 2 Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy in Patients With Colorectal Cancer (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Shanghai Junshi Bioscience Co., Ltd.
    New P2 trial
    |
    capecitabine • oxaliplatin
    11ms
    JS015 Combined Therapy in Gastrointestinal Tumors: A Multi-Cohort, Multi-Center, Exploratory Clinical Study (ChiCTR2400091501)
    P2, N=56, Shanghai East Hospital; Shanghai East Hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 negative
    |
    Avastin (bevacizumab) • Loqtorzi (toripalimab-tpzi)
    12ms
    A Phase Ib/II Study Of JS015 Combination Therapy in Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=186, Recruiting, Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting --> Recruiting | Trial completion date: Apr 2026 --> Jan 2026
    Enrollment open • Trial completion date • Metastases
    |
    Avastin (bevacizumab) • gemcitabine • 5-fluorouracil • Loqtorzi (toripalimab-tpzi) • capecitabine • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium
    1year
    JS015 in combination with chemotherapy and bevacizumab as second-line treatment in advanced colorectal cancer (ChiCTR2400088962)
    P2, N=37, Not yet recruiting, Shanghai East Hospital; Shanghai East Hospital
    New P2 trial • Combination therapy • Metastases
    |
    Avastin (bevacizumab)
    1year
    DKN-01 in Combination With Tislelizumab and Chemotherapy as First-Line Therapy in Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: DisTinGuish. (PubMed, J Clin Oncol)
    DKN-01 can be safely combined with frontline fluoropyrimidine/oxaliplatin and tislelizumab and demonstrates encouraging activity independent of PD-L1 expression levels. A randomized phase II trial is ongoing (ClinicalTrials.gov identifier: NCT04363801).
    Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • DKK1 (dickkopf WNT signaling pathway inhibitor 1)
    |
    PD-L1 expression • HER-2 negative
    |
    Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • sirexatamab (DKN-01)
    1year
    Characterization of cell states in biliary tract cancers identifies mechanisms of therapeutic resistance in a phase II trial of DKN-01/nivolumab. (PubMed, medRxiv)
    Malignant cell states co-varied with distinct immune cell states, revealing diverse mechanisms of myeloid and T-cell mediated immune suppression, including M2 myeloid and terminally exhausted T cell programs that were induced by DKN-01/nivolumab. Here, we provide the first systematic classification of functionally annotated cell states in biliary tract cancer and provide new insight into resistance mechanisms to an immunotherapy combination that can inform the next generation of trials.
    P2 data • Journal
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    DKK1 (dickkopf WNT signaling pathway inhibitor 1)
    |
    Opdivo (nivolumab) • sirexatamab (DKN-01)