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    DRUG:

    Jiataile (sacituzumab tirumotecan)

    i
    Other names: MK-2870, SKB 264, SKB264, sac-TMT, SKB-264, MK2870, MK 2870
    Company:
    Merck (MSD), Sichuan Kelun Pharma
    Drug class:
    Topoisomerase I inhibitor, TROP-2-targeted antibody-drug conjugate
    Related drugs:
    1d
    Sacituzumab Tirumotecan Combined With Immunotherapy in Advanced Thyroid Cancer (clinicaltrials.gov)
    P=N/A, N=55, Not yet recruiting, Zhejiang Provincial People's Hospital
    New trial
    |
    Tevimbra (tislelizumab-jsgr) • Jiataile (sacituzumab tirumotecan)
    6d
    KEYMAKER-U06 substudy 06B: A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B) (clinicaltrials.gov)
    P1/2, N=200, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Sep 2028 --> Apr 2029
    Trial completion date
    |
    Keytruda (pembrolizumab) • paclitaxel • Lenvima (lenvatinib) • irinotecan • Jiataile (sacituzumab tirumotecan) • MK-4830
    8d
    A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) (clinicaltrials.gov)
    P3, N=2400, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • Lynparza (olaparib) • carboplatin • paclitaxel • doxorubicin hydrochloride • capecitabine • cyclophosphamide • epirubicin • Jiataile (sacituzumab tirumotecan)
    10d
    Sacituzumab Tirumotecan Combined With Pembrolizumab for Neoadjuvant Treatment of TNBC Breast Cancer (clinicaltrials.gov)
    P2, N=52, Not yet recruiting, Yantai Yuhuangding Hospital
    New P2 trial
    |
    Keytruda (pembrolizumab) • Jiataile (sacituzumab tirumotecan)
    1m
    Results of a phase 1/2 study of sacituzumab tirumotecan in patients with unresectable locally advanced or metastatic solid tumors refractory to standard therapies. (PubMed, J Hematol Oncol)
    Sac-TMT demonstrated manageable safety profile in patients with unresectable locally advanced/metastatic solid tumors and promising antitumor activity in metastatic TNBC and HR+/HER2 - breast cancer. Sac-TMT is being investigated in phase 3 studies.
    P1/2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Jiataile (sacituzumab tirumotecan) • Camtobell (belotecan)
    1m
    Clinical study on the use of dexamethasone mouthwash to prevent oral inflammation in patients with malignant tumors treated with Sacituzumab Tirumotecan (ChiCTR2500103349)
    P=N/A, N=56, Not yet recruiting, Beijing Luhe Hospital Affiliated to Capital Medical University; Beijing Luhe Hospital Affiliated to Capital Medical University
    New trial
    |
    Jiataile (sacituzumab tirumotecan)
    1m
    A Prospective, Single-center, Phase II Study of Sacituzumab Tirumotecan in Combination with Pembrolizumab for Neoadjuvant Treatment of Triple-Negative Breast Cancer (TNBC) (ChiCTR2500103244)
    P2, N=52, Not yet recruiting, Yantai Yuhuangding Hospital; Yantai Yuhuangding Hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Keytruda (pembrolizumab) • Jiataile (sacituzumab tirumotecan)
    1m
    An open, multicenter study on the treatment of recurrent and metastatic triple-negative breast cancer guided by cell surface protein typing (HIM) in triple-negative breast cancer (ChiCTR2500101840)
    P=N/A, N=120, Not yet recruiting, Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • PD-1 (Programmed cell death 1)
    |
    HER-2 negative • ER negative
    |
    Lenvima (lenvatinib) • AiRuiKa (camrelizumab) • albumin-bound paclitaxel • Jiataile (sacituzumab tirumotecan)
    1m
    Sacituzumab tirumotecan versus docetaxel for previously treated EGFR-mutated advanced non-small cell lung cancer: multicentre, open label, randomised controlled trial. (PubMed, BMJ)
    Sac-TMT showed statistically significant and clinically meaningful improvements in objective response rate, progression-free survival, and overall survival compared with docetaxel, with a manageable safety profile in patients with EGFR-mutated locally advanced or metastatic NSCLC.
    Clinical • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    docetaxel • Jiataile (sacituzumab tirumotecan)
    1m
    A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29) (clinicaltrials.gov)
    P3, N=1123, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open • Mismatch repair • pMMR
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • docetaxel • Jiataile (sacituzumab tirumotecan)
    2ms
    Sacituzumab Tirumotecan (MK-2870) as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-2870-008) (clinicaltrials.gov)
    P1, N=36, Active, not recruiting, Merck Sharp & Dohme LLC | Trial completion date: Nov 2025 --> Jan 2027 | Trial primary completion date: Nov 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • Jiataile (sacituzumab tirumotecan)
    2ms
    Real-world Study of SKB264 Monotherapy or Combination Therapy in Recurrent or Metastatic HER2-negative Breast Cancer (clinicaltrials.gov)
    P=N/A, N=500, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    New trial • Real-world evidence
    |
    Jiataile (sacituzumab tirumotecan)
    2ms
    PROTECT-2: Trilaciclib in Patients Receiving Sacituzumab Tirumotecan for EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=49, Not yet recruiting, The First Affiliated Hospital of Xiamen University
    New P2 trial
    |
    Cosela (trilaciclib) • Jiataile (sacituzumab tirumotecan)
    2ms
    Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01) (clinicaltrials.gov)
    P1/2, N=1410, Active, not recruiting, Klus Pharma Inc. | Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2025 --> Dec 2025
    Enrollment closed • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • MSI (Microsatellite instability) • BRCA (Breast cancer early onset) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    MSI-H/dMMR • HER-2 negative • HER-2 expression • EGFR wild-type • HER-2 underexpression • BRCA mutation
    |
    Jiataile (sacituzumab tirumotecan)
    2ms
    A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) (clinicaltrials.gov)
    P3, N=2400, Not yet recruiting, Merck Sharp & Dohme LLC
    New P3 trial
    |
    Keytruda (pembrolizumab) • Lynparza (olaparib) • carboplatin • paclitaxel • doxorubicin hydrochloride • capecitabine • cyclophosphamide • epirubicin • Jiataile (sacituzumab tirumotecan)
    2ms
    LIGHTBEAM-02A: A Clinical Study of MK-2870 Alone or With Chemotherapy to Treat Gastrointestinal Cancers (MK-9999-02A) (clinicaltrials.gov)
    P1/2, N=130, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Dec 2028 --> Oct 2029 | Trial primary completion date: Dec 2028 --> Oct 2029
    Trial completion date • Trial primary completion date
    |
    5-fluorouracil • Jiataile (sacituzumab tirumotecan) • levoleucovorin calcium
    2ms
    A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103) (clinicaltrials.gov)
    P3, N=770, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Jun 2031 --> Oct 2032
    Trial completion date • Platinum sensitive
    |
    Avastin (bevacizumab) • Jiataile (sacituzumab tirumotecan)
    3ms
    A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29) (clinicaltrials.gov)
    P3, N=1123, Not yet recruiting, Merck Sharp & Dohme LLC
    New P3 trial • Mismatch repair • pMMR
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • docetaxel • Jiataile (sacituzumab tirumotecan)
    3ms
    Sacituzumab tirumotecan in advanced non-small-cell lung cancer with or without EGFR mutations: phase 1/2 and phase 2 trials. (PubMed, Nat Med)
    Randomized phase 3 trials in treatment-naive and previously treated patients with EGFR-mutant NSCLC are ongoing. ClinicalTrials.gov Identifiers: NCT04152499 , NCT05631262 .
    P1/2 data • P2 data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR wild-type
    |
    Jiataile (sacituzumab tirumotecan)
    3ms
    A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011) (clinicaltrials.gov)
    P3, N=1000, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • carboplatin • gemcitabine • albumin-bound paclitaxel • Jiataile (sacituzumab tirumotecan)
    4ms
    A Clinical Study to Evaluate the Efficacy and Safety of SKB264 in Combination with Sintilimab for Initially Unresectable Stage III Non-Small Cell Lung Cancer (ChiCTR2500099670)
    P=N/A, N=30, Not yet recruiting, Shapingba District People's Hospital, Chongqing; Shapingba District People's Hospital Affiliated with Chongqing University
    New trial
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK mutation • ROS1 fusion • ALK translocation • EGFR negative
    |
    Tyvyt (sintilimab) • Jiataile (sacituzumab tirumotecan)
    4ms
    TroFuse-027: A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027) (clinicaltrials.gov)
    P1/2, N=32, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Nov 2026 --> Jul 2028
    Trial completion date
    |
    Jiataile (sacituzumab tirumotecan)
    4ms
    A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103) (clinicaltrials.gov)
    P3, N=770, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting | Trial completion date: Oct 2032 --> Jun 2031 | Trial primary completion date: Apr 2030 --> Apr 2029
    Enrollment open • Trial completion date • Trial primary completion date
    |
    Avastin (bevacizumab) • Jiataile (sacituzumab tirumotecan)
    4ms
    Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01) (clinicaltrials.gov)
    P2, N=60, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • pemetrexed • Jiataile (sacituzumab tirumotecan)
    5ms
    SKB264-Ⅱ-08: SKB264 Monotherapy in Selected Subjects with Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=321, Active, not recruiting, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2024 --> Dec 2025
    Enrollment closed • Trial primary completion date
    |
    ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • EGFR wild-type • ALK fusion
    |
    docetaxel • Jiataile (sacituzumab tirumotecan)
    5ms
    SHIFT-001: HIM Typing Guides the Treatment of Advanced First-Line Triple-Negative Breast Cancer (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Fudan University
    New P2 trial
    |
    Lenvima (lenvatinib) • AiRuiKa (camrelizumab) • albumin-bound paclitaxel • Jiataile (sacituzumab tirumotecan)
    5ms
    A Study of SKB264 in Combination with Osimertinib Versus Osimertinib in Patients with Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=420, Recruiting, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Tagrisso (osimertinib) • Jiataile (sacituzumab tirumotecan)
    5ms
    A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011) (clinicaltrials.gov)
    P3, N=1000, Not yet recruiting, Merck Sharp & Dohme LLC
    New P3 trial
    |
    Keytruda (pembrolizumab) • carboplatin • gemcitabine • albumin-bound paclitaxel • Jiataile (sacituzumab tirumotecan)
    5ms
    A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103) (clinicaltrials.gov)
    P3, N=770, Not yet recruiting, Merck Sharp & Dohme LLC
    New P3 trial
    |
    Avastin (bevacizumab) • Jiataile (sacituzumab tirumotecan)
    6ms
    Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01) (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Merck Sharp & Dohme LLC
    New P2 trial
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • pemetrexed • Jiataile (sacituzumab tirumotecan)
    6ms
    TroFuse-027: A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027) (clinicaltrials.gov)
    P1/2, N=32, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Jiataile (sacituzumab tirumotecan)
    7ms
    Sacituzumab Tirumotecan (MK-2870) as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-2870-008) (clinicaltrials.gov)
    P1; Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Nov 2025 | Trial primary completion date: Jun 2025 --> Nov 2025
    Trial completion date • Trial primary completion date • Enrollment closed
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • Jiataile (sacituzumab tirumotecan)
    7ms
    SKB264-II-06: SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors (clinicaltrials.gov)
    P2, N=240, Recruiting, Klus Pharma Inc. | N=184 --> 240 | Trial completion date: Nov 2025 --> Dec 2027 | Trial primary completion date: Sep 2025 --> Nov 2026
    Enrollment change • Trial completion date • Trial primary completion date • Pan tumor
    |
    Keytruda (pembrolizumab) • Jiataile (sacituzumab tirumotecan)
    7ms
    OptiTROP-Breast01: SKB264 Injection Vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer (clinicaltrials.gov)
    P3, N=254, Active, not recruiting, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Trial completion date: Dec 2024 --> Mar 2025
    Trial completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation • HER-2 negative • HER-2 expression • PGR negative • HER-2 negative + HR positive + BRCA mutation
    |
    gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • Jiataile (sacituzumab tirumotecan)
    8ms
    A Study of SKB264 in Combination with Pembrolizumab Versus Chemotherapy in Combination with Pembrolizumab As First-Line Treatment for PD-L1 Negative Patients with Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=432, Recruiting, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
    New P3 trial • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • Jiataile (sacituzumab tirumotecan)
    8ms
    A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers (clinicaltrials.gov)
    P2; N=130; Not yet recruiting; Sponsor:Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Union Hospital, Tongji Medical College, Huazhong University of
    Combination therapy • New P2 trial
    |
    MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • BRCA (Breast cancer early onset) • CD4 (CD4 Molecule)
    |
    MSI-H/dMMR • BRCA mutation • MSH6 expression
    |
    FoundationOne® CDx
    |
    5-fluorouracil • Jiataile (sacituzumab tirumotecan)
    9ms
    A Study of SKB264 in Combination with Osimertinib Versus Osimertinib in Patients with Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=420, Not yet recruiting, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
    New P3 trial
    |
    Tagrisso (osimertinib) • Jiataile (sacituzumab tirumotecan)
    9ms
    TroFuse-027: A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027) (clinicaltrials.gov)
    P1/2, N=32, Not yet recruiting, Merck Sharp & Dohme LLC
    New P1/2 trial
    |
    Jiataile (sacituzumab tirumotecan)
    10ms
    SKB264-II-04: A Study of SKB264 for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=498, Recruiting, Klus Pharma Inc. | N=278 --> 498
    Enrollment change • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK fusion
    |
    Keytruda (pembrolizumab) • Tagrisso (osimertinib) • carboplatin • Jiataile (sacituzumab tirumotecan)
    11ms
    KEYMAKER-06C: Substudy 06C: A Study of Sacituzumab Tirumotecan (MK-2870) With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06) (clinicaltrials.gov)
    P1/2, N=130, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Keytruda (pembrolizumab) • 5-fluorouracil • capecitabine • oxaliplatin • Jiataile (sacituzumab tirumotecan) • levoleucovorin calcium
    12ms
    A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20) (clinicaltrials.gov)
    P3, N=686, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    gemcitabine • pemetrexed • irinotecan • vinorelbine tartrate • topotecan • Jiataile (sacituzumab tirumotecan) • Tivdak (tisotumab vedotin-tftv)
    12ms
    Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06) (clinicaltrials.gov)
    P1/2, N=90, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • paclitaxel • Cyramza (ramucirumab) • Jiataile (sacituzumab tirumotecan)