^
    15h
    Phase 1 Study Of Izalontamab Brengitecan + Adagrasib In NSCLC - The IZA-A Trial (clinicaltrials.gov)
    P1, N=18, Not yet recruiting, M.D. Anderson Cancer Center
    New P1 trial
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    KRAS (KRAS proto-oncogene GTPase)
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    KRAS mutation
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    Krazati (adagrasib) • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    1d
    MRG003 Combined With Immunotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, West China Hospital
    New P2 trial
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    Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin)
    4d
    Efficacy and Safety of Becotatug Vedotin (EGFR ADC) plus Pucotenlimab and Cisplatin as Neoadjuvant Therapy for LA-HNSCC (ChiCTR2600115972)
    P=N/A, N=30, Not yet recruiting, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
    New trial
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    PD-L1 (Programmed death ligand 1)
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    PD-L1 IHC 22C3 pharmDx
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    cisplatin • Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin) • becotarug (JMT101)
    4d
    An open-label, multicenter, phase II study to evaluate the efficacy and safety of SYS6010 combined with enlonstobart in the recurrent or metastatic head and neck squamous cell carcinoma (ChiCTR2500112871)
    P2, N=70, Not yet recruiting, Shanghai East Hospital, Tongji University(Shanghai East Hospital); Shanghai East Hospital, Tongji University(Shanghai East Hospital)
    New P2 trial
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    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
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    Enshuxing (enlonstobart) • SYS6010
    4d
    A Study of SYS6010 Combined with Osimertinib versus Osimertinib alone as Neoadjuvant Therapy for Patients with EGFRm Resectable Non-squamous Non-small Cell Lung Cancer (ChiCTR2500113154)
    P2, N=120, Not yet recruiting, Shanghai Chest Hospital; Shanghai Pulmonary Hospital; CSPC Megalith Biopharmaceutical Co., Ltd
    New P2 trial
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    EGFR (Epidermal growth factor receptor)
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    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
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    Tagrisso (osimertinib) • SYS6010 • simmitinib (SYHA1817)
    4d
    Phase II/III Trial of SYS6010 plus Enlonstobart Injection ± Chemotherapy in Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ChiCTR2500112440)
    P2/3, N=737, Not yet recruiting, Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center
    New P2/3 trial
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    PD-L1 (Programmed death ligand 1)
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    EGFR expression
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    cisplatin • paclitaxel • 5-fluorouracil • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr) • capecitabine • leucovorin calcium • Enshuxing (enlonstobart) • SYS6010
    4d
    A First-In-Human, Multicenter, Open-Label Phase I/II Investigational Study to Evaluate the Safety, Tolerability, Pharmacokinetics, And Preliminary Efficacy of KY-0301 as monotherapy or combined with other anticancer agents in Patients with advanced Solid Tumors (ChiCTR2600116103)
    P1/2, N=120, Recruiting, Shanghai East Hospital; Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
    New P1/2 trial
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
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    PD-L1 expression • KRAS mutation • EGFR mutation • MSI-H/dMMR • BRAF mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • ALK rearrangement • EGFR wild-type • MET exon 14 mutation • KRAS wild-type • RAS wild-type • ROS1 fusion • ROS1 rearrangement • MET mutation • NTRK fusion
    4d
    Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of BL-B01D1 for Injection in Patients with Locally Advanced or Metastatic Solid Tumors (ChiCTR2500113663)
    P1, N=500, Not yet recruiting, Sun Yat-sen University Cancer Center; Sichuan Baili Pharmaceutical Co., Ltd.
    New P1 trial
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
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    BRAF V600E • KRAS mutation • EGFR mutation • KRAS G12C • BRAF V600 • RET fusion • MET exon 14 mutation • ALK fusion • EGFR L861Q • RET mutation • ROS1 fusion • EGFR G719X • MET mutation • EGFR S768I • KRAS G12 • NTRK fusion
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    izalontamab brengitecan (BL-B01D1)
    6d
    SYNSTAR-02: A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P3, N=450, Not yet recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd.
    New P3 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Tagrisso (osimertinib) • SYS6010 • simmitinib (SYHA1817)
    6d
    Izalontamab brengitecan (Iza-bren; BL-B01D1), a first-in-class EGFR-HER3 bispecific antibody-drug conjugate, for patients with EGFR-mutated NSCLC: Pooled analysis of phase 1 and phase 2 trials. (PubMed, Ann Oncol)
    In this exploratory post hoc pooled analysis, Iza-bren demonstrated promising antitumor activity and a manageable safety profile in heavily pretreated EGFR-mutated NSCLC. These findings are hypothesis-generating and are being further evaluated in ongoing randomized trials.
    P1 data • P2 data • Retrospective data • Journal
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    ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    EGFR mutation
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    izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    9d
    Clinical Trial Evaluating TQB6411 Injection in Subjects With Esophageal Cancer (clinicaltrials.gov)
    P1/2, N=105, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P1/2 trial
    9d
    A Clinical Trial on the Efficacy and Safety of TQB6411 for Injection (clinicaltrials.gov)
    P1/2, N=465, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P1/2 trial