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    DRUG CLASS:

    HER3-targeted antibody-drug conjugate

    Related drugs:
    4d
    Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009) (clinicaltrials.gov)
    P1/2, N=81, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Perjeta (pertuzumab) • Tukysa (tucatinib) • patritumab deruxtecan (U3-1402) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    5d
    Evaluation of JSKN016 Combination Therapy in Subjects with NSCLC (clinicaltrials.gov)
    P1, N=288, Not yet recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd
    New P1 trial
    |
    Keytruda (pembrolizumab) • carboplatin • docetaxel • Tevimbra (tislelizumab-jsgr) • Ivesa (firmonertinib) • Yidafan (ivonescimab)
    10d
    Quantitative Protein Expression of Antibody-Drug Conjugate Targets in EGFR Mutated and Wild-Type Non-Small Cell Lung Cancer. (PubMed, Clin Cancer Res)
    ADC targets are highly expressed in NSCLC, implying that the benefit from these agents may be broad. Benefit from these therapies may go beyond mutation status and fully quantitative approaches may help to select patients for ADC targeting. Inter-target correlation may provide insight on the underlying signaling pathways and/or treatment-related resistant mechanisms. In the future, QIF may be a valuable tool to select ADC treatment sequence.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    EGFR mutation • HER-2 expression • EGFR expression • EGFR wild-type
    11d
    Whole Body HER3 Quantification With Radiolabelled Patritumab Deruxtecan (HER3-DXd) PET/CT (clinicaltrials.gov)
    P2, N=16, Recruiting, The Netherlands Cancer Institute | Not yet recruiting --> Recruiting
    Enrollment open
    |
    ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    patritumab deruxtecan (U3-1402)
    11d
    A Phase I Study of AK138D1 in the Treatment of Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=100, Recruiting, Akeso | Not yet recruiting --> Recruiting
    Enrollment open
    12d
    A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma (clinicaltrials.gov)
    P3, N=674, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
    |
    paclitaxel • docetaxel • izalontamab brengitecan (BL-B01D1)
    13d
    A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=696, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Tagrisso (osimertinib) • izalontamab brengitecan (BL-B01D1)
    20d
    HER3-targeting Antibody-drug Conjugates Therapy for Solid Tumors: Recent Advances and Future Potentials. (PubMed, Curr Med Chem)
    This review summarizes recent advances and future potentials, aiming to provide insights into targeted therapy. We hope that this review will provide useful information to physicians in the field.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • ERBB4 (erb-b2 receptor tyrosine kinase 4)
    |
    patritumab deruxtecan (U3-1402)
    24d
    Antibody-drug conjugates in NSCLC with actionable genomic alterations: Optimizing smart delivery of chemotherapy to the target. (PubMed, Cancer Treat Rev)
    We also discuss the challenges with respect to appropriate biomarker selection, dose optimization, treatment duration, and optimization of the structural design of ADC components to maximize efficacy while minimizing off-target toxicity. Finally, addressing cost-effectiveness concerns remains critical for their successful adoption within healthcare systems.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    HER-2 overexpression • HER-2 mutation • MET overexpression
    25d
    A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=696, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
    |
    Tagrisso (osimertinib) • izalontamab brengitecan (BL-B01D1)
    2ms
    Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03) (clinicaltrials.gov)
    P2, N=372, Not yet recruiting, Merck Sharp & Dohme LLC
    New P2 trial
    |
    Keytruda (pembrolizumab) • Lynparza (olaparib) • carboplatin • paclitaxel • doxorubicin hydrochloride • capecitabine • cyclophosphamide • epirubicin • patritumab deruxtecan (U3-1402)
    2ms
    A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Chordoma (clinicaltrials.gov)
    P2, N=40, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial
    |
    izalontamab brengitecan (BL-B01D1)
    2ms
    Evaluation of JSKN016 in the Treatment of Advanced Non-small Cell Lung Cance： a Phase II Clinical Study (clinicaltrials.gov)
    P2, N=220, Not yet recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd
    New P2 trial
    |
    docetaxel
    2ms
    A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P3, N=500, Recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cisplatin • carboplatin • SHR-A2009
    3ms
    SHR-A2009-I-102: The Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=19, Completed, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Active, not recruiting --> Completed | Trial completion date: Jun 2026 --> Apr 2024 | Trial primary completion date: Jun 2025 --> Apr 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    SHR-A2009
    3ms
    A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=218, Recruiting, Bristol-Myers Squibb | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Keytruda (pembrolizumab) • Tagrisso (osimertinib) • izalontamab brengitecan (BL-B01D1)
    3ms
    A Study of U3-1402 (Patritumab Deruxtecan) in Subjects with Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=121, Active, not recruiting, SCRI Development Innovations, LLC | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    ER (Estrogen receptor) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    HER-2 positive • HER-2 negative • HER-2 expression • ERBB3 expression
    |
    patritumab deruxtecan (U3-1402)
    3ms
    PARAMETer: A Window of Opportunity Study of Patritumab Deruxtecan in Patients with Brain Metastases (clinicaltrials.gov)
    P2, N=15, Not yet recruiting, Mustafa Khasraw, MBChB, MD, FRCP, FRACP | Phase classification: P1 --> P2
    Phase classification
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    patritumab deruxtecan (U3-1402)
    3ms
    A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor (clinicaltrials.gov)
    P1, N=96, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    izalontamab brengitecan (BL-B01D1)
    3ms
    BL-B01D1-104: A Study of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors (clinicaltrials.gov)
    P1, N=36, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    3ms
    BL-B01D1-101: A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor (clinicaltrials.gov)
    P1, N=96, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    3ms
    Predictive Factors of Antibody-Drug Conjugate Treatment in Metastatic Breast Cancer: A Narrative Review. (PubMed, Cancers (Basel))
    This narrative review explores key predictive factors influencing the efficacy of ADCs, focusing on HER2-targeted therapies, such as trastuzumab emtansine and trastuzumab deruxtecan, as well as sacituzumab govitecan for triple-negative breast cancer. Finally, future perspectives on the sequential use of ADCs and potential combination therapies are highlighted, along with emerging agents targeting alternative antigens like HER3 and LIV-1. Overall, identifying predictive biomarkers and overcoming resistance mechanisms are essential for optimizing the use of ADCs in metastatic breast cancer, thereby improving patient outcomes.
    Review • Journal • Metastases
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    ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    HER-2 expression
    |
    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Trodelvy (sacituzumab govitecan-hziy)
    3ms
    A Phase I Study of AK138D1 in the Treatment of Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=100, Not yet recruiting, Akeso
    New P1 trial • Metastases
    3ms
    Patritumab Deruxtecan in Patients with Solid Tumor Harboring an NRG1 Fusion (clinicaltrials.gov)
    P2, N=30, Recruiting, Samsung Medical Center | Not yet recruiting --> Recruiting
    Enrollment open • Pan tumor
    |
    patritumab deruxtecan (U3-1402)
    4ms
    The Era of Antibody Drug Conjugates in Lung Cancer: Trick or Threat? (PubMed, Cancer Res Treat)
    Antibody Drug Conjugates (ADCs) are a novel class of therapeutics that structurally are composed by an antibody directed to a tumour epitope connected via a linker to a cytotoxic payload, and that have shown significant antitumor activity across a range of malignancies including lung cancer. In this article we review the pharmacology and design of ADCs, as well as we describe the results of different studies evaluating ADCs in lung cancer directed to several targets including HER2, HER3, TROP2, MET, CEACAM5 and DLL3, among others.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • CEACAM5 (CEA Cell Adhesion Molecule 5) • DLL3 (Delta Like Canonical Notch Ligand 3)
    4ms
    Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=350, Recruiting, Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    trastuzumab rezetecan (SHR-A1811) • Ariely (adebrelimab) • SHR-A2009
    4ms
    PARAMETer: A Window of Opportunity Study of Patritumab Deruxtecan in Patients With Brain Metastases (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, Mustafa Khasraw, MBChB, MD, FRCP, FRACP | Trial completion date: Jan 2027 --> Apr 2027 | Trial primary completion date: Jan 2025 --> Apr 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    patritumab deruxtecan (U3-1402)
    4ms
    A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC (clinicaltrials.gov)
    P2, N=180, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Active, not recruiting --> Recruiting
    Enrollment open • Metastases
    |
    BNT326
    4ms
    Study of ORM-5029 in Subjects with HER2-Expressing Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=87, Active, not recruiting, Orum Therapeutics USA, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    ORM-5029
    4ms
    A Study of YL202 in Selected Patients with Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=200, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Active, not recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    BNT326
    4ms
    Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009) (clinicaltrials.gov)
    P1/2, N=81, Not yet recruiting, Merck Sharp & Dohme LLC
    New P1/2 trial
    |
    Perjeta (pertuzumab) • Tukysa (tucatinib) • patritumab deruxtecan (U3-1402) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    4ms
    A Multicenter, Open-label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Subjects With Locally Advanced or Metastatic Breast Cancer Who Are TNBC and HR Positive, HER2 Zero, or HER2 Hypoactive (ChiCTR2400089158)
    P2, N=180, Recruiting, Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center
    New P2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HR positive • HER-2 negative • HER-2 expression • HER-2 underexpression • PGR expression • HER-2 negative + HR negative
    |
    BNT326
    4ms
    A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Profiles, and Preliminary Efficacy of SYS6023 in Patients with Advanced Solid Tumors (ChiCTR2400089836)
    P1, N=388, Recruiting, Shanghai Chest Hospital; CSPC Megalith Biopharmaceutical Co., Ltd
    New P1 trial • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • PGR (Progesterone receptor) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • NRG1 (Neuregulin 1) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • EGFR mutation • KRAS G12C • BRAF mutation • HER-2 amplification • HER-2 negative • BRAF V600 • HER-2 expression • ALK positive • MET amplification • ALK fusion • ERBB3 expression • RET mutation • ROS1 fusion • MET mutation • NRG1 fusion • RET rearrangement • KRAS G12 • KRAS amplification • ER expression • PGR expression • ALK-ROS1 fusion • NRG1 fusion • NTRK fusion
    4ms
    ICARUS-BREAST01: Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=99, Active, not recruiting, Gustave Roussy, Cancer Campus, Grand Paris | Recruiting --> Active, not recruiting | N=170 --> 99 | Trial completion date: Jun 2026 --> Apr 2028 | Trial primary completion date: Jan 2024 --> Apr 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    patritumab deruxtecan (U3-1402)
    4ms
    A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P3, N=500, Not yet recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd.
    New P3 trial • Metastases
    |
    cisplatin • carboplatin • SHR-A2009
    4ms
    HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy (clinicaltrials.gov)
    P3, N=586, Active, not recruiting, Daiichi Sankyo | Trial primary completion date: Aug 2024 --> May 2024
    Trial primary completion date • Metastases
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    cisplatin • carboplatin • patritumab deruxtecan (U3-1402)
    4ms
    Characterization of patritumab deruxtecan activity in breast cancer (BC) patient-derived xenograft (PDX) models (SABCS 2024)
    The antitumor activity of HER3-DXd (10 mg/kg or 3 mg/kg dosed once weekly, 4 doses in total; Q1W x 4) was assessed in 30 BC PDX models (21 ER+/HER2- and 9 triple negative [TNBC]) and compared to the antitumor activity of the clinically approved TOP1 inhibitor irinotecan (50 mg/kg dosed once weekly; Q1W). HER3-DXd exerts a potent antitumor response in BC PDXs across baseline levels of HER3/ERBB3 expression in ER+/HER2- and TNBC models. Based on our data, basal-like PDX models were more likely to show long-term responses to HER3-DXd than luminal B PDX models. Results also suggest that BRCA1/2-altered PARPi-resistant tumors will show high benefit with HER3-DXd treatment.
    Clinical • PARP Biomarker • BRCA Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • RB1 (RB Transcriptional Corepressor 1) • RPA2 (Replication Protein A2)
    |
    HER-2 negative • HER-2 expression • ERBB3 expression • ERBB3 overexpression
    |
    MSK-IMPACT • Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    irinotecan • patritumab deruxtecan (U3-1402)
    4ms
    Primary results of SOLTI VALENTINE: neoadjuvant randomized phase II trial of HER3-DXd alone or in combination with letrozole for high-risk hormone receptor positive (HR+)/HER2-negative (neg) early breast cancer (EBC). (SABCS 2024)
    Pts were randomized 2:2:1 to: (A) HER3-DXd 5.6 mg/kg every (Q) 21 days (D) for 6 cycles; (B) HER3-DXd plus QD LET (+/- LHRH agonist); (C) CT with 4 cycles of EC/AC (epirubicin 90 mg/m2 or doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 Q14 or 21 D) followed by weekly paclitaxel 80mg/m2 for 12 weeks. In SOLTI VALENTINE, treatment with HER3-DXd, with or without LET, resulted in similar pCR rates to CT, while exhibiting a lower incidence of grade ≥3 TEAEs. CelTIL score at C2D1 correlated with response to HER3-DXd, but not to CT. The ongoing translational analysis, as well as the survival outcomes of VALENTINE, will provide further insights into the activity of HER3-DXd in EBC and clarify its potential role as a treatment strategy for high-risk HR+/HER2-neg breast cancer.
    Combination therapy • Late-breaking abstract • P2 data • Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    paclitaxel • doxorubicin hydrochloride • cyclophosphamide • letrozole • epirubicin • patritumab deruxtecan (U3-1402)
    5ms
    A Study of BL-B01D1 in Patients With Recurrent Glioblastoma (clinicaltrials.gov)
    P2, N=20, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    izalontamab brengitecan (BL-B01D1)
    5ms
    A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies (clinicaltrials.gov)
    P2, N=130, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=98 --> 130
    Enrollment change • Combination therapy • Metastases
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    5ms
    Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (clinicaltrials.gov)
    P1/2, N=130, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    patritumab deruxtecan (U3-1402)
    5ms
    A Clinical Trial of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients. (clinicaltrials.gov)
    P1, N=144, Recruiting, Shanghai Institute Of Biological Products | Not yet recruiting --> Recruiting
    Enrollment open • Metastases