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    DRUG CLASS:

    CD137 agonist

    Related drugs:
    5d
    A Study to Evaluate the Efficacy and Safety of QLF31907 Combination Therapy in Patients With Advanced Malignant Tumors (clinicaltrials.gov)
    P1/2, N=60, Not yet recruiting, Qilu Pharmaceutical Co., Ltd.
    New P1/2 trial • Combination therapy • Metastases
    |
    docetaxel • irinotecan • QL301
    6d
    GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer (clinicaltrials.gov)
    P2, N=0, Withdrawn, Genmab | N=80 --> 0 | Initiation date: Apr 2024 --> Oct 2023 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial initiation date • Trial withdrawal • Combination therapy • Metastases
    |
    MSI (Microsatellite instability) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • acasunlimab (GEN1046)
    11d
    RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis (clinicaltrials.gov)
    P1/2, N=12, Not yet recruiting, Cabaletta Bio | Trial completion date: Jul 2028 --> Sep 2029 | Initiation date: May 2024 --> Aug 2024 | Trial primary completion date: Jul 2028 --> Sep 2029
    Trial completion date • Trial initiation date • Trial primary completion date • CAR T-Cell Therapy
    |
    cyclophosphamide
    11d
    Acasunlimab (DuoBody-PD-L1x4-1BB) alone or in combination with pembrolizumab (pembro) in patients (pts) with previously treated metastatic non-small cell lung cancer (mNSCLC): Initial results of a randomized, open-label, phase 2 trial. (ASCO 2024)
    Clinical Trial Registration Number: NCT05117242
    Combination therapy • P2 data • Clinical • Metastases
    |
    Keytruda (pembrolizumab) • acasunlimab (GEN1046)
    13d
    PRS-343-PCS_04_16: PRS-343 in HER2-Positive Solid Tumors (clinicaltrials.gov)
    P1, N=85, Completed, Pieris Pharmaceuticals, Inc. | Trial completion date: Oct 2021 --> Dec 2023 | Trial primary completion date: Oct 2021 --> Dec 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    cinrebafusp alfa (PRS-343)
    13d
    A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC) (clinicaltrials.gov)
    P2, N=64, Not yet recruiting, Lyvgen Biopharma Holdings Limited
    New P2 trial • Combination therapy • Metastases
    |
    paclitaxel • Loqtorzi (toripalimab-tpzi) • exlinkibart (LVGN6051)
    14d
    PRS-343 in Combination With Atezolizumab in HER2-Positive Solid Tumors (clinicaltrials.gov)
    P1, N=41, Completed, Pieris Pharmaceuticals, Inc. | Active, not recruiting --> Completed | Phase classification: P1b --> P1
    Trial completion • Phase classification • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Tecentriq (atezolizumab) • cinrebafusp alfa (PRS-343)
    17d
    Study of LVGN6051 (CD137 Agonist Antibody) in Advanced or Metastatic Malignancy (clinicaltrials.gov)
    P1, N=18, Completed, Lyvgen Biopharma Holdings Limited | Terminated --> Completed
    Trial completion • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • exlinkibart (LVGN6051)
    25d
    RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis (clinicaltrials.gov)
    P1/2, N=12, Not yet recruiting, Cabaletta Bio
    New P1/2 trial • CAR T-Cell Therapy
    |
    cyclophosphamide
    1m
    Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer (clinicaltrials.gov)
    P1, N=67, Active, not recruiting, Agenus Inc. | Recruiting --> Active, not recruiting | N=200 --> 67
    Enrollment closed • Enrollment change • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    BRAF V600
    |
    botensilimab (AGEN1181) • AGEN2373
    1m
    RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis (clinicaltrials.gov)
    P1/2, N=12, Not yet recruiting, Cabaletta Bio
    New P1/2 trial • CAR T-Cell Therapy
    |
    cyclophosphamide
    1m
    A Study of GNC-035, a Tetra-specific Antibody, in Participants With Relapsed/Refractory Hematologic Malignancy (clinicaltrials.gov)
    P1, N=58, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    nebratamig (GNC-035)
    1m
    Immuno-positron Emission Tomography Study of 89Zr-S095012 in Patients With Advanced Solid Tumours (clinicaltrials.gov)
    P1, N=33, Recruiting, Institut de Recherches Internationales Servier | Trial completion date: Oct 2023 --> Sep 2025 | Trial primary completion date: Oct 2023 --> Jun 2025
    Trial completion date • Trial primary completion date • Metastases
    2ms
    Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer (clinicaltrials.gov)
    P2, N=160, Recruiting, Genmab | Trial completion date: Jun 2024 --> Mar 2027 | Trial primary completion date: Mar 2024 --> Nov 2024
    Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • Metastases
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • acasunlimab (GEN1046)
    2ms
    NBL-028-001: A Study of NBL-028 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=270, Recruiting, NovaRock Biotherapeutics, Ltd | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    2ms
    Development of a c-MET x CD137 bispecific antibody for targeted immune agonism in cancer immunotherapy. (PubMed, Cancer Treat Res Commun)
    Overall, the c-MET x CD137 BsAb exhibits a promising developability profile as a tumor-targeted immune agonist by minimizing off-target effects while effectively delivering immune agonism. It has the potential to overcome resistance to anti-PD-(L)1 therapies.
    Journal
    |
    MET (MET proto-oncogene, receptor tyrosine kinase) • TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    MET expression
    |
    Keytruda (pembrolizumab) • utomilumab (PF-05082566) • urelumab (BMS-663513)
    2ms
    Study of LVGN6051 (CD137 Agonist Antibody) in Advanced or Metastatic Malignancy (clinicaltrials.gov)
    P1, N=18, Terminated, Lyvgen Biopharma Holdings Limited | N=50 --> 18 | Trial completion date: Jul 2024 --> Oct 2023 | Recruiting --> Terminated | Trial primary completion date: Apr 2024 --> Oct 2023; The study was terminated due to product development strategy adjustment,there were no safety concerns.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • exlinkibart (LVGN6051)
    2ms
    A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=110, Recruiting, Eutilex | Trial completion date: Feb 2025 --> Dec 2025 | Trial primary completion date: Sep 2023 --> Sep 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    MSI-H/dMMR • RAS mutation
    |
    EU101
    2ms
    Final results of urelumab, an anti-CD137 agonist monoclonal antibody, in combination with cetuximab or nivolumab in patients with advanced solid tumors. (PubMed, J Immunother Cancer)
    Although the addition of urelumab at these doses was tolerable, preliminary response rates did not indicate an evident additive benefit. Nevertheless, the positive pharmacodynamics effects observed with urelumab and the high response rate in treatment-naive patients with melanoma warrant further investigation of other anti-CD137 agonist agents for treatment of cancer.
    Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    CD8 (cluster of differentiation 8) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • GZMB (Granzyme B)
    |
    Opdivo (nivolumab) • Erbitux (cetuximab) • urelumab (BMS-663513)
    2ms
    Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment (clinicaltrials.gov)
    P1/2, N=80, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Jul 2025 --> Dec 2024 | Trial primary completion date: Jul 2025 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression • CEACAM5 overexpression
    |
    Gazyva (obinutuzumab) • RG7827 • cibisatamab (RG7802)
    2ms
    GEN1046 Safety Trial in Patients With Malignant Solid Tumors (clinicaltrials.gov)
    P1/2, N=429, Active, not recruiting, Genmab | N=752 --> 429
    Enrollment change
    |
    Keytruda (pembrolizumab) • docetaxel • acasunlimab (GEN1046)
    2ms
    GEN1046 Safety and PK in Subjects With Advanced Solid Malignancies (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, Genmab | Recruiting --> Active, not recruiting | N=39 --> 18
    Enrollment closed • Enrollment change • Metastases
    |
    Keytruda (pembrolizumab) • acasunlimab (GEN1046)
    2ms
    Safety/Tolerability, PK and Efficacy of IMB071703 Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=93, Recruiting, Beijng Immunoah Pharma Tech Co., Ltd.
    New P1 trial • Metastases
    2ms
    A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=52, Terminated, Numab Therapeutics AG | N=406 --> 52 | Active, not recruiting --> Terminated | Trial primary completion date: Oct 2023 --> Feb 2024; A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.
    Enrollment change • Trial termination • Trial primary completion date • Trispecific • Metastases
    |
    NM21-1480
    2ms
    CBT307-1: A Phase I Study to Assess PSMA+ and PSMA- Tumour Lesions (clinicaltrials.gov)
    P1, N=5, Active, not recruiting, Crescendo Biologics Ltd. | Recruiting --> Active, not recruiting | N=12 --> 5 | Trial completion date: Dec 2023 --> Oct 2024
    Enrollment closed • Enrollment change • Trial completion date
    |
    CB307
    3ms
    GNC-035-103: A Study of GNC-035, a Tetra-specific Antibody, in Participants With Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=29, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Nov 2023 --> Jun 2024 | Trial primary completion date: Nov 2023 --> Jun 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    nebratamig (GNC-035)
    3ms
    A Study of GNC-039, a Tetra-specific Antibody, in Participants With Relapsed/Refractory or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=147, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Dec 2023 --> Jun 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    GNC-039
    3ms
    PROBE: A Study ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas (clinicaltrials.gov)
    P1, N=40, Recruiting, Antengene Biologics Limited | N=482 --> 40
    Enrollment change • Metastases
    |
    ATG-101
    3ms
    Preclinical characterization and phase 1 results of ADG106 in patients with advanced solid tumors and non-Hodgkin's lymphoma. (PubMed, Cell Rep Med)
    Circulating biomarkers suggest target engagement by ADG106 and immune modulation of circulating T, B, and natural killer cells and cytokines interferon γ and interleukin-6, which may affect the probability of clinical efficacy. ADG106 has a manageable safety profile and preliminary anti-tumor efficacy in patients with advanced cancers (this study was registered at ClinicalTrials.gov: NCT03802955).
    P1 data • Preclinical • Journal • IO biomarker • Metastases
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    ADG106
    3ms
    Efficacy and safety of autologous tumor-infiltrating lymphocytes in recurrent or refractory ovarian cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. (PubMed, J Immunother Cancer)
    TIL manufactured with assistance of 4-1BB and CD3 agonism is feasible and treatment is associated with no new safety signals. While no responses were observed, a significant portion of patients achieved SD suggesting early/partial immunological effect. Further research is required to identify factors associated with resistance and functionally enhance T cells for a more effective therapy.
    Journal • Tumor-infiltrating lymphocyte
    |
    CD8 (cluster of differentiation 8) • ENTPD1 (Ectonucleoside Triphosphate Diphosphohydrolase 1)
    |
    ENTPD1 expression
    |
    urelumab (BMS-663513)
    3ms
    GEN1046 Safety Trial in Patients With Malignant Solid Tumors (clinicaltrials.gov)
    P1/2, N=752, Active, not recruiting, Genmab | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Keytruda (pembrolizumab) • docetaxel • acasunlimab (GEN1046)
    3ms
    ADG116-1003: A Phase 1b/2 Study of ADG116, ADG116 Combined With Anti-PD-1 Antibody or Anti-CD137 Antibody in Solid Tumors Patients (clinicaltrials.gov)
    P1, N=72, Active, not recruiting, Adagene Inc | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Loqtorzi (toripalimab-tpzi) • ADG106
    3ms
    Dose Escalation and Expansion Study of BH3120 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=191, Recruiting, Hanmi Pharmaceutical Company Limited
    New P1 trial
    3ms
    A Study of NBL-028 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=270, Not yet recruiting, NovaRock Biotherapeutics, Ltd
    New P1 trial • Metastases
    3ms
    A Phase Ia Clinical Study of QLF31907 Injection in Patients With Advanced Malignant Tumors (clinicaltrials.gov)
    P1, N=54, Recruiting, Qilu Pharmaceutical Co., Ltd. | Trial completion date: Sep 2022 --> Jun 2024 | Trial primary completion date: Jul 2022 --> Mar 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    QL301
    4ms
    RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus (clinicaltrials.gov)
    P1/2, N=12, Recruiting, Cabaletta Bio | Initiation date: Oct 2023 --> Jan 2024
    Trial initiation date • CAR T-Cell Therapy
    |
    cyclophosphamide
    4ms
    Safety, Pharmacokinetics, and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab (BGB-A317) in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=55, Active, not recruiting, BeiGene | Recruiting --> Active, not recruiting | Phase classification: P1a/1b --> P1 | N=254 --> 55 | Trial completion date: Aug 2025 --> Jan 2025
    Enrollment closed • Phase classification • Enrollment change • Trial completion date • Combination therapy • Metastases
    |
    Tevimbra (tislelizumab) • BGB-B167
    4ms
    A Study of LM-24C5 For Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=49, Recruiting, LaNova Medicines Limited | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    LM-24C5
    4ms
    A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma (clinicaltrials.gov)
    P1/2, N=68, Recruiting, Nanjing Leads Biolabs Co.,Ltd | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    cisplatin • carboplatin • etoposide IV
    4ms
    A Study of LM-24C5 For Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=49, Not yet recruiting, LaNova Medicines Limited
    New P1/2 trial • Metastases
    |
    LM-24C5
    4ms
    A Study of GNC-035 in Relapsed or Refractory Non-Hodgkin 's Lymphoma and Other Hematological Malignancies (clinicaltrials.gov)
    P1/2, N=40, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    Trial completion date • Trial primary completion date
    |
    nebratamig (GNC-035)
    4ms
    A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=406, Active, not recruiting, Numab Therapeutics AG
    Trial completion date • Trispecific • Metastases
    |
    NM21-1480