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    DRUG:

    Cotelet (tagitanlimab)

    i
    Other names: HBM9167, A 167, KL A167, KLA167, A167, KL-A167, A-167, HBM 9167, HBM-9167
    Associations

    News

    Trials
    Company:
    Akesobio, Harbour BioMed, Sichuan Kelun Pharma
    Drug class:
    PD-L1 inhibitor
    Related drugs:
    Associations

    News

    Trials
    8d
    A prospective, single-arm, phase II clinical trial of sacituzumab tirumotecan (SKB264) in combination with tagitanlimab (KL-A167) as second-line therapy for immune-resistant extensive-stage small cell lung cancer (ES-SCLC) (ChiCTR2500111691)
    P2, N=40, Not yet recruiting, Shandong First Medical University Affiliated Cancer Hospital (Shandong Provincial Institute of Cancer Prevention and Treatment, Shandong Provincial Ca
    New P2 trial
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    Jiataile (sacituzumab tirumotecan) • Cotelet (tagitanlimab)
    11d
    ST-A-TN: Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With KL-A167 for Neoadjuvant Treatment of Triple-Negative Breast Cancer (clinicaltrials.gov)
    P2, N=40, Recruiting, Shanghai Jiao Tong University School of Medicine
    New P2 trial
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 negative
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    carboplatin • albumin-bound paclitaxel • Jiataile (sacituzumab tirumotecan) • Cotelet (tagitanlimab)
    3ms
    OptiTROP-Breast05: SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer (clinicaltrials.gov)
    P2, N=175, Active, not recruiting, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Jul 2025 --> Sep 2027 | Trial primary completion date: Apr 2025 --> Sep 2027
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Jiataile (sacituzumab tirumotecan) • Cotelet (tagitanlimab)
    3ms
    SKB315-I-01: A Study of SKB315 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=246, Recruiting, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Trial completion date: Feb 2026 --> Jun 2028 | Trial primary completion date: Dec 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    CLDN18 (Claudin 18)
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    capecitabine • Cotelet (tagitanlimab) • SKB315
    3ms
    SKB264 combined with KL-A167 neoadjuvant therapy for early-stage, high-risk ER+/HER2- breast cancer (ChiCTR2500108090)
    P2, N=55, Not yet recruiting, West China Hospital of Sichuan University; West China Hospital of Sichuan University
    New P2 trial
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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    Jiataile (sacituzumab tirumotecan) • Cotelet (tagitanlimab)
    5ms
    Sacituzumab Tirumotecan in Combination With Tagitanlimab in the Treatment of Aggressive Variant Prostate Cancer (AVPC) and Neuroendocrine Prostate Cancer (NEPC) (clinicaltrials.gov)
    P2, N=28, Recruiting, Tianjin Medical University Second Hospital
    New P2 trial
    |
    Jiataile (sacituzumab tirumotecan) • Cotelet (tagitanlimab)
    5ms
    Sacituzumab Tirumotecan Plus Tagitanlimab in Previously Treated Locally Advanced or Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=47, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
    |
    Jiataile (sacituzumab tirumotecan) • Cotelet (tagitanlimab)
    6ms
    NeoSaciA: SKB264 Combined With KL-A167 Neoadjuvant Therapy for Early-stage, High-risk ER+/HER2- Breast Cancer (clinicaltrials.gov)
    P2, N=55, Not yet recruiting, West China Hospital
    New P2 trial
    |
    Jiataile (sacituzumab tirumotecan) • Cotelet (tagitanlimab)
    6ms
    A Single-center, Phase II Clinical Trial Evaluating the Efficacy of Sacituzumab Tirumotecan in Combination With Tagitanlimab as Neoadjuvant Therapy for PD-L1-positive, Resectable Stage II to IIIB Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=52, Not yet recruiting, Henan Cancer Hospital
    New P2 trial
    |
    Jiataile (sacituzumab tirumotecan) • Cotelet (tagitanlimab)
    6ms
    A Single-arm, Multicenter, Phase 2 Study of Sacituzumab tirumotecan (Sac-TMT) in Combination With KL-A167 as Maintenance Therapy in Extensive Stage Small Cell Lung Cancer (ES-SCLC) After First Line Immunochemotherapy Induction Therapy (ChiCTR2500104246)
    P2, N=39, Not yet recruiting, Shanghai Pulmonary Hospital; Shanghai Pulmonary Hospital
    New P2 trial
    |
    Jiataile (sacituzumab tirumotecan) • Cotelet (tagitanlimab)
    8ms
    KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov)
    P3, N=295, Active, not recruiting, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Trial completion date: May 2025 --> Dec 2027 | Trial primary completion date: May 2024 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    cisplatin • gemcitabine • Cotelet (tagitanlimab)
    almost2years
    Sacituzumab tirumotecan (SKB264/MK-2870) in combination with KL-A167 (anti-PD-L1) as first-line treatment for patients with advanced NSCLC from the phase II OptiTROP-Lung01 study. (ASCO 2024)
    Background: Sacituzumab Tirumotecan (SKB264/MK-2870)is a TROP2 ADC developed with novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor. SKB264 in combination with KL-A167 demonstrated promising efficacy results in treatment naive advanced NSCLC with manageable safety profile. SKB264 Q2W was recommended for further investigation. A Phase 3 study of SKB264 Q2W plus pembrolizumab vs pembrolizumab in 1L metastatic NSCLC with PD-L1 TPS ≥ 50% (NCT06170788) is ongoing.
    Combination therapy • P2 data • Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
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    PD-L1 IHC 22C3 pharmDx
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    Keytruda (pembrolizumab) • Jiataile (sacituzumab tirumotecan) • Camtobell (belotecan) • Cotelet (tagitanlimab)