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    DRUG:

    sacituzumab tirumotecan (MK-2870)

    i
    Other names: MK-2870, SKB 264, SKB264
    Company:
    Merck (MSD), Sichuan Kelun Pharma
    Drug class:
    Topoisomerase I inhibitor, TROP-2-targeted antibody-drug conjugate
    Related drugs:
    6d
    A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015) (clinicaltrials.gov)
    P3, N=450, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    paclitaxel • docetaxel • irinotecan • Lonsurf (trifluridine/tipiracil) • sacituzumab tirumotecan (MK-2870)
    18d
    Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (clinicaltrials.gov)
    P3, N=1530, Not yet recruiting, Merck Sharp & Dohme LLC
    New P3 trial • Combination therapy • Surgery
    |
    Keytruda (pembrolizumab) • capecitabine • sacituzumab tirumotecan (MK-2870)
    1m
    A Study to Assess Efficacy and Safety of Pembrolizumab With or Without MK- 2870 in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019) (clinicaltrials.gov)
    P3, N=780, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open • Surgery
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • pemetrexed • sacituzumab tirumotecan (MK-2870)
    1m
    A Study to Evaluate MK-2870 in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015) (clinicaltrials.gov)
    P3, N=450, Not yet recruiting, Merck Sharp & Dohme LLC
    New P3 trial • Metastases
    |
    paclitaxel • docetaxel • irinotecan • Lonsurf (trifluridine/tipiracil) • sacituzumab tirumotecan (MK-2870)
    1m
    A Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010) (clinicaltrials.gov)
    P3, N=1200, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • capecitabine • albumin-bound paclitaxel • pegylated liposomal doxorubicin • sacituzumab tirumotecan (MK-2870)
    2ms
    A Study to Assess Efficacy and Safety of Pembrolizumab With or Without MK- 2870 in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019) (clinicaltrials.gov)
    P3, N=780, Not yet recruiting, Merck Sharp & Dohme LLC
    New P3 trial • Surgery
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • pemetrexed • sacituzumab tirumotecan (MK-2870)
    2ms
    A Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010) (clinicaltrials.gov)
    P3, N=1200, Not yet recruiting, Merck Sharp & Dohme LLC
    New P3 trial • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • capecitabine • albumin-bound paclitaxel • pegylated liposomal doxorubicin • sacituzumab tirumotecan (MK-2870)
    2ms
    MK-2870 Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) and Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009) (clinicaltrials.gov)
    P3, N=520, Not yet recruiting, Merck Sharp & Dohme LLC
    New P3 trial • Combination therapy • Metastases
    |
    carboplatin • pemetrexed • dexamethasone • sacituzumab tirumotecan (MK-2870)
    2ms
    Phase 3 MK-2870-007 study: MK-2870 (SKB264) plus pembrolizumab vs pembrolizumab alone as first-line treatment for metastatic non-small-cell lung cancer with PD-L1 tumor proportion score (TPS) ≥50% (AACR 2024)
    AEs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0. Enrollment began in December 2023 and is currently ongoing.
    Clinical • PD(L)-1 Biomarker • IO biomarker • Tumor proportion score • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    TROP2 expression • TROP2 overexpression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • sacituzumab tirumotecan (MK-2870)
    3ms
    A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov)
    P3, N=524, Not yet recruiting, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
    New P3 trial
    |
    carboplatin • capecitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate) • sacituzumab tirumotecan (MK-2870)
    4ms
    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: Dec 2026 --> Sep 2028 | Trial primary completion date: Feb 2025 --> Nov 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab) • paclitaxel • Lenvima (lenvatinib) • irinotecan • sacituzumab tirumotecan (MK-2870) • MK-4830
    4ms
    MK-2870 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007) (clinicaltrials.gov)
    P3, N=614, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Tumor proportion score • Metastases
    |
    Keytruda (pembrolizumab) • sacituzumab tirumotecan (MK-2870)
    5ms
    MK-2870 in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005) (clinicaltrials.gov)
    P3, N=710, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    paclitaxel • doxorubicin hydrochloride • sacituzumab tirumotecan (MK-2870)
    5ms
    MK-2870 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007) (clinicaltrials.gov)
    P3, N=614, Not yet recruiting, Merck Sharp & Dohme LLC
    New P3 trial
    |
    Keytruda (pembrolizumab) • sacituzumab tirumotecan (MK-2870)
    5ms
    SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer. (clinicaltrials.gov)
    P2, N=110, Recruiting, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Not yet recruiting --> Recruiting | Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Aug 2023 --> Aug 2024
    Enrollment open • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • EGFR wild-type • ALK fusion • ALK negative
    |
    cisplatin • carboplatin • sacituzumab tirumotecan (MK-2870) • tagitanlimab (HBM9167)
    5ms
    MK-2870 in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005) (clinicaltrials.gov)
    P3, N=710, Not yet recruiting, Merck Sharp & Dohme LLC | Phase classification: P2/3 --> P3
    Phase classification
    |
    paclitaxel • doxorubicin hydrochloride • sacituzumab tirumotecan (MK-2870)
    6ms
    MK-2870 Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004) (clinicaltrials.gov)
    P3, N=556, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene)
    |
    EGFR mutation • EGFR T790M
    |
    docetaxel • pemetrexed • sacituzumab tirumotecan (MK-2870)
    6ms
    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 | N=300 --> 200
    Enrollment change • Metastases
    |
    Keytruda (pembrolizumab) • paclitaxel • Lenvima (lenvatinib) • irinotecan • sacituzumab tirumotecan (MK-2870) • MK-4830
    6ms
    MK-2870 in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005) (clinicaltrials.gov)
    P2/3, N=710, Not yet recruiting, Merck Sharp & Dohme LLC
    New P2/3 trial
    |
    paclitaxel • doxorubicin hydrochloride • sacituzumab tirumotecan (MK-2870)
    7ms
    MK-2870 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-2870-008) (clinicaltrials.gov)
    P1; Not yet recruiting --> Recruiting
    Combination therapy • Enrollment open • Metastases
    |
    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) • carboplatin • sacituzumab tirumotecan (MK-2870)
    7ms
    SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=366, Recruiting, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Not yet recruiting --> Recruiting | N=237 --> 366
    Enrollment open • Enrollment change • Metastases
    |
    ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • EGFR wild-type • ALK fusion
    |
    docetaxel • sacituzumab tirumotecan (MK-2870)
    7ms
    SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer (clinicaltrials.gov)
    P2, N=175, Recruiting, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting | N=95 --> 175 | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Apr 2024 --> Apr 2025
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    sacituzumab tirumotecan (MK-2870) • tagitanlimab (HBM9167)
    7ms
    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-Biotech Biopharmaceutical Co., Ltd. | Not yet recruiting --> Active, not recruiting
    Enrollment closed • 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
    |
    gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • sacituzumab tirumotecan (MK-2870)
    7ms
    A Phase III Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P3, N=376, Not yet recruiting, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
    New P3 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • sacituzumab tirumotecan (MK-2870)
    7ms
    MK-2870 Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004) (clinicaltrials.gov)
    P3, N=556, Not yet recruiting, Merck Sharp & Dohme LLC
    New P3 trial • Metastases
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene)
    |
    EGFR mutation • EGFR T790M
    |
    docetaxel • pemetrexed • sacituzumab tirumotecan (MK-2870)
    8ms
    MK-2870 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-2870-008) (clinicaltrials.gov)
    P1; N=48; Not yet recruiting; Sponsor:Merck Sharp & Dohme LLC
    Combination therapy • New P1 trial • Metastases
    |
    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) • carboplatin • sacituzumab tirumotecan (MK-2870)
    10ms
    SKB264 (MK-2870) in previously treated hormone receptor-positive (HR+)/ HER2-negative metastatic breast cancer (mBC): Results from a phase I/II, single-arm, basket trial (ESMO 2023)
    SKB264 is a novel anti-TROP2 ADC developed using sulfonyl pyrimidine-CL2A-carbonate linker to conjugate its payload, a belotecan-derivative topoisomerase I inhibitor, to achieve an average Drug-to-antibody Ratio (DAR) of 7.4. Conclusions SKB264 at 5 mg/kg demonstrates a manageable safety profile and promising antitumor activity in pts with pre-treated HR+/HER2- mBC. Two phase 3 studies are currently planned in HR+/HER2- mBC, one in China for pts after at least one chemo for mBC and a second global for pts previously untreated with chemo for mBC, both comparing SKB264 vs investigator selected chemo.
    P1/2 data • Pan tumor • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    HR positive • HER-2 overexpression • HER-2 negative
    |
    sacituzumab tirumotecan (MK-2870) • Camtobell (belotecan)
    12ms
    A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients (clinicaltrials.gov)
    P3, N=356, Not yet recruiting, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
    New P3 trial • Combination therapy • Metastases
    |
    EGFR mutation
    |
    cisplatin • carboplatin • pemetrexed • sacituzumab tirumotecan (MK-2870)
    1year
    A Study of SKB264 for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=296, Recruiting, Klus Pharma Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK fusion
    |
    Keytruda (pembrolizumab) • Tagrisso (osimertinib) • carboplatin • sacituzumab tirumotecan (MK-2870)
    1year
    SKB264 (TROP2-ADC) for the treatment of patients with advanced NSCLC: Efficacy and safety data from a phase 2 study. (ASCO 2023)
    SKB264 is a novel anti-TROP2 ADC developed using sulfonyl pyrimidine-CL2A-carbonate linker to conjugate its payload, a belotecan-derivative topoisomerase I inhibitor, to achieve an average Drug-to-antibody Ratio (DAR) of 7.4. SKB264 at 5 mg/kg Q2W demonstrated encouraging anti-tumor activity and manageable safety profile in pts with relapsed or refractory locally advanced/metastatic NSCLC. TRAEs were mainly hematologic. Phase 3 studies of SKB264 in pts with advanced NSCLC have been planned.
    Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • TROP2 (Trophoblast Cell Surface Antigen 2) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    EGFR mutation • EGFR wild-type • TROP2 expression
    |
    sacituzumab tirumotecan (MK-2870) • Camtobell (belotecan)
    1year
    A Study of SKB264 for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=296, Not yet recruiting, Klus Pharma Inc.
    New P2 trial • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK fusion
    |
    Keytruda (pembrolizumab) • Tagrisso (osimertinib) • carboplatin • sacituzumab tirumotecan (MK-2870)
    1year
    SHR-A1921, a novel TROP-2 ADC with an optimized design and well-balanced profile between efficacy and safety (AACR 2023)
    Compared with other Trop-2-targeted ADCs in the field, such as Trodelvy, TINA-SHR79711 (a molecule synthesized using the published structure of DS-1062), and SKB264, SHR-A1921 has considerable advantages as follows: (1) Stronger binding affinity to both human and rhesus macaque TROP-2 than TINA-SHR79711; (2) Improved plasma stability in plasma of different species presumably due to the proper steric hindrance which was purposely designed on the payload for reducing non-intended cleavage; (3) Stronger bystander cell killing effect presumably due to the increased lipophilicity of the payload vs. that of the payload in TINA-SHR79711; (4) Superior in vivo efficacy in a PSCC2 CDX Model (FaDu) with high Trop-2 expression (TGI 101% vs 53% [TINA-SHR79711] @ 1 mpk) and in an ovarian cancer CDX Model (SK-OV-3) with moderate Trop-2 expression (TGI 63% vs. 23% [TINA-SHR79711] @ 3 mpk; 87% vs. 16% [TINA-SHR79711] @ 10 mpk); (5) ≥ 2X longer half-life in patients# vs. SKB264 vs. IMMU-132, supporting more flexible dosing frequency; (6) Lower free toxin/ADC ratio# regarding PK exposure in patients compared with SKB264 (< 1% vs. 5-6%); (7) approximately linear pharmacokinetics profile in patients with T1/2 ranging from 2.5 to 4.5 days. #. non-head-to-head comparison.)
    Clinical • Late-breaking abstract
    |
    TROP2 (Trophoblast Cell Surface Antigen 2)
    |
    Trodelvy (sacituzumab govitecan-hziy) • datopotamab deruxtecan (DS-1062a) • sacituzumab tirumotecan (MK-2870) • SHR-A1921
    over1year
    Preclinical profiles of SKB264, a novel anti-TROP2 antibody conjugated to topoisomerase inhibitor, demonstrated promising antitumor efficacy compared to IMMU-132. (PubMed, Front Oncol)
    The aim of this study was to improve the intratumoral accumulation of an antibody-drug conjugate (ADC) and minimize its off-target toxicity, SKB264, a novel anti-trophoblast antigen 2 (TROP2) ADC that was developed using 2-methylsulfonyl pyrimidine as the linker to conjugate its payload (KL610023), a belotecan-derivative topoisomerase I inhibitor. At the same dose, SKB264's exposure in tumor tissue was 4.6-fold higher than that of IMMU-132. Compared with IMMU-132, the longer half-life of SKB264 had a stronger targeting effect and better antitumor activity, suggesting the better therapeutic potential of SKB264 for treating TROP2-positive tumors.
    Preclinical • Journal
    |
    TROP2 (Trophoblast Cell Surface Antigen 2)
    |
    TROP2 positive
    |
    Trodelvy (sacituzumab govitecan-hziy) • sacituzumab tirumotecan (MK-2870) • Camtobell (belotecan)
    over1year
    Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (clinicaltrials.gov)
    P1/2, N=430, Recruiting, Klus Pharma Inc. | N=250 --> 430
    Enrollment change • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • MSI (Microsatellite instability) • TROP2 (Trophoblast Cell Surface Antigen 2) • 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 • TROP2 expression • BRCA mutation
    |
    sacituzumab tirumotecan (MK-2870)
    almost2years
    Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (clinicaltrials.gov)
    P1/2, N=250, Recruiting, Klus Pharma Inc. | Trial completion date: Dec 2022 --> Dec 2025 | Trial primary completion date: Nov 2022 --> Nov 2024
    Trial completion date • Trial primary completion date
    |
    TROP2 (Trophoblast Cell Surface Antigen 2)
    |
    TROP2 expression
    |
    sacituzumab tirumotecan (MK-2870)
    2years
    A Phase Ⅱ Clinical Study of Combination Therapy of SKB264 in Patients With Advanced or Metastatic Non-small Cell Lung Cancer. (clinicaltrials.gov)
    P2, N=110, Not yet recruiting, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
    New P2 trial • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • EGFR wild-type • ALK fusion • ALK negative
    |
    cisplatin • carboplatin • sacituzumab tirumotecan (MK-2870) • tagitanlimab (HBM9167)
    2years
    SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer (clinicaltrials.gov)
    P3, N=254, Not yet recruiting, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
    New P3 trial
    |
    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
    |
    gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • sacituzumab tirumotecan (MK-2870)
    2years
    Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (clinicaltrials.gov)
    P1/2, N=250, Recruiting, Klus Pharma Inc. | Trial primary completion date: Feb 2022 --> Nov 2022
    Trial primary completion date
    |
    TROP2 (Trophoblast Cell Surface Antigen 2)
    |
    TROP2 expression
    |
    sacituzumab tirumotecan (MK-2870)
    almost3years
    Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (clinicaltrials.gov)
    P1/2, N=250, Recruiting, Klus Pharma Inc. | N=78 --> 250
    Clinical • Enrollment change
    |
    TROP2 (Trophoblast Cell Surface Antigen 2)
    |
    TROP2 expression
    |
    sacituzumab tirumotecan (MK-2870)
    4years
    [VIRTUAL] SKB264 ADC: A first-in-human study of SKB264 in patients with locally advanced unresectable/metastatic solid tumors who are refractory to available standard therapies. (ASCO 2020)
    SKB264 is being developed as a further optimized TROP2-targeting ADC with a proprietary cytotoxic, belotecan-derived payload and novel stable conjugation chemistry to achieve average DAR (Drug Antibody Ratio) of 7.4. The enrollment will began in Mar 2020 in USA sites. Research Funding: KLUS Pharm Inc.
    Clinical • P1 data
    |
    TROP2 (Trophoblast Cell Surface Antigen 2)
    |
    TROP2 expression
    |
    sacituzumab tirumotecan (MK-2870) • Camtobell (belotecan)