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    DRUG CLASS:

    CCR8 inhibitor

    Related drugs:
    12d
    SRF114-101: Study of CHS-114 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=87, Recruiting, Coherus Biosciences, Inc. | N=47 --> 87
    Enrollment change
    |
    PD-L1 (Programmed death ligand 1)
    |
    Loqtorzi (toripalimab-tpzi) • CHS-114
    15d
    BGB-A3055 Alone and in Combination With Tislelizumab in Participants With Solid Tumors (clinicaltrials.gov)
    P1, N=263, Recruiting, BeiGene | Trial completion date: Feb 2025 --> Mar 2027 | Trial primary completion date: Feb 2025 --> Mar 2027
    Trial completion date • Trial primary completion date
    |
    CCR8 (C-C Motif Chemokine Receptor 8)
    |
    Tevimbra (tislelizumab-jsgr) • BGB-A3055
    18d
    Phase1/2a Study for IPG7236 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=196, Recruiting, Nanjing Immunophage Biotech Co., Ltd | Phase classification: P1 --> P1/2
    Phase classification
    |
    IPG7236
    22d
    A Study of LM-108 in Combination With Toripalimab in Subjects With Advanced Solid Tumours (clinicaltrials.gov)
    P2, N=84, Not yet recruiting, LaNova Medicines Limited
    New P2 trial • Mismatch repair • IO biomarker
    |
    Loqtorzi (toripalimab-tpzi) • cafelkibart (LM-108)
    1m
    A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=450, Recruiting, Genentech, Inc. | Trial primary completion date: Apr 2026 --> Aug 2026
    Trial primary completion date • Checkpoint inhibition
    |
    Keytruda (pembrolizumab) • Tecentriq (atezolizumab)
    2ms
    Study of DT-7012 As a Single Agent and in Combination with an Immune Checkpoint Inhibitor in Participants with Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=60, Not yet recruiting, Domain Therapeutics SA
    New P1/2 trial
    3ms
    KEYNOTE-F22: A Phase 1 Study of ZL-1218 in Subjects With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=60, Recruiting, Zai Lab (Hong Kong), Ltd. | Active, not recruiting --> Recruiting | Trial completion date: Nov 2025 --> Mar 2027 | Trial primary completion date: Nov 2024 --> Mar 2026
    Enrollment open • Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • ZL-1218
    3ms
    Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CM369 in Advanced Solid Tumors & Hematologic Malignancies (clinicaltrials.gov)
    P1, N=146, Recruiting, Beijing InnoCare Pharma Tech Co., Ltd. | Trial completion date: Apr 2025 --> Feb 2026 | Trial primary completion date: Jun 2024 --> Oct 2025
    Trial completion date • Trial primary completion date
    4ms
    A First-in-human Study to Learn How Safe the Study Drug BAY3375968, an Anti-CCR8 Antibody, is, When Given Alone or in Combination With Pembrolizumab, How it Affects the Body, How it Moves Into, Through, and Out of the Body, and to Find the Best Dose in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=354, Recruiting, Bayer | N=270 --> 354
    Enrollment change • Metastases
    |
    Keytruda (pembrolizumab)
    4ms
    Phase1/2a Study for IPG7236 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=196, Recruiting, Nanjing Immunophage Biotech Co., Ltd | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Sep 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    IPG7236
    5ms
    A Study of CHS-114 in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=40, Not yet recruiting, Coherus Biosciences, Inc.
    New P1 trial
    |
    Loqtorzi (toripalimab-tpzi) • CHS-114
    5ms
    KEYNOTE-F22: A Phase 1 Study of ZL-1218 in Subjects With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=60, Active, not recruiting, Zai Lab (Hong Kong), Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • ZL-1218
    6ms
    Study of LM-108 as a Single Agent or in Combination With Anti-PD-1 Antibody in Subjects With Advanced Solid Tumours (clinicaltrials.gov)
    P1/2, N=60, Recruiting, LaNova Australia Pty Limited | Trial completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Mar 2024 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    cafelkibart (LM-108)
    6ms
    Study of LM-108 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours (clinicaltrials.gov)
    P1/2, N=392, Enrolling by invitation, LaNova Medicines Limited | Recruiting --> Enrolling by invitation
    Enrollment status • Combination therapy • Metastases
    |
    Loqtorzi (toripalimab-tpzi) • cafelkibart (LM-108)
    8ms
    Preclinical development of a novel CCR8/CTLA-4 bispecific antibody for cancer treatment by disrupting CTLA-4 signaling on CD8 T cells and specifically depleting tumor-resident Tregs. (PubMed, Cancer Immunol Immunother)
    In cynomolgus monkeys, 2MW4691 was well-tolerated, exhibited the anticipated pharmacokinetic profile, and had a minimal impact on the peripheral T cell population. The promising preclinical results supported the further evaluation of 2MW4691 as a next-generation Treg-based therapeutics in clinical trials.
    Preclinical • Journal • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CCR8 (C-C Motif Chemokine Receptor 8)
    8ms
    A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=905, Recruiting, Bristol-Myers Squibb | N=665 --> 905 | Trial completion date: Sep 2026 --> Dec 2026 | Trial primary completion date: Apr 2025 --> Dec 2025
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • docetaxel
    10ms
    Selective depletion of tumor-infiltrating regulatory T cells with BAY 3375968, a novel Fc-optimized anti-CCR8 antibody. (PubMed, Clin Exp Med)
    Collectively, these findings suggest that CCR8 targeting represents a promising strategy for Treg depletion in cancer therapies. BAY 3375968 is currently under investigation in a Phase I clinical trial (NCT05537740).
    Journal
    |
    CCR8 (C-C Motif Chemokine Receptor 8)
    12ms
    IPG7236 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=196, Recruiting, Nanjing Immunophage Biotech Co., Ltd | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    IPG7236
    1year
    Study of GS-1811 Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=376, Recruiting, Gilead Sciences | N=216 --> 376 | Trial completion date: Feb 2027 --> Dec 2027 | Trial primary completion date: Jun 2026 --> Dec 2027
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Yutuo (zimberelimab) • denikitug (GS-1811)
    1year
    aCCeleR8-001: S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=274, Recruiting, Shionogi | Phase classification: P1b/2 --> P1/2
    Phase classification • Combination therapy • Checkpoint inhibition • Metastases
    |
    Keytruda (pembrolizumab) • S-531011
    1year
    A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=515, Recruiting, Amgen | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab)
    1year
    Study of CHS-114 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=47, Recruiting, Coherus Biosciences, Inc. | Phase classification: P1/2 --> P1 | N=70 --> 47
    Phase classification • Enrollment change • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    CHS-114
    over1year
    A Study of BGB-A3055, Alone and in Combination With Tislelizumab in Participants With Selected Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=318, Recruiting, BeiGene
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    CCR8 (C-C Motif Chemokine Receptor 8)
    |
    Tevimbra (tislelizumab-jsgr) • BGB-A3055
    over1year
    A Study of BGB-A3055, Alone and in Combination With Tislelizumab in Participants With Selected Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=318, Recruiting, BeiGene | Phase classification: P1a/1b --> P1
    Phase classification • Combination therapy • Metastases
    |
    CCR8 (C-C Motif Chemokine Receptor 8)
    |
    Tevimbra (tislelizumab-jsgr) • BGB-A3055
    over1year
    Study of LM-108 as a Single Agent or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumours (clinicaltrials.gov)
    P1/2, N=24, Terminated, LaNova Medicines Limited | N=54 --> 24 | Trial completion date: Dec 2023 --> Aug 2023 | Recruiting --> Terminated | Trial primary completion date: Nov 2023 --> Aug 2023; Completed primary objective.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • cafelkibart (LM-108)
    over1year
    Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CM369 in Advanced Solid Tumors & Hematologic Malignancies (clinicaltrials.gov)
    P1, N=146, Recruiting, Beijing InnoCare Pharma Tech Co., Ltd. | N=82 --> 146
    Enrollment change • Metastases
    over1year
    Study of LM-108 as a Single Agent or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumours (clinicaltrials.gov)
    P1/2, N=54, Recruiting, LaNova Medicines Limited | Trial completion date: Sep 2024 --> Dec 2023 | Trial primary completion date: Jul 2024 --> Nov 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • cafelkibart (LM-108)
    over1year
    Anti-CCR8 antibody CHS-114 (SRF114) depletes tumor-infiltrating regulatory T cells in dissociated tumors from patients with head and neck squamous cell carcinoma (SITC 2023)
    Molecular epidemiology studies highlight HNSCC as a tumor type with a high prevalence of CCR8+ itTregs to evaluate the anti-tumor activity of an anti-CCR8 antibody. CHS-114 (SRF114) is currently being evaluated in a Phase 1 clinical trial (NCT05635643).
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • FOXP3 (Forkhead Box P3) • CCR8 (C-C Motif Chemokine Receptor 8)
    |
    CCR8 expression • FOXP3 expression
    |
    CHS-114
    over1year
    A Study of BGB-A3055, Alone and in Combination With Tislelizumab in Participants With Selected Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1a/1b, N=318, Recruiting, BeiGene | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • IO biomarker • Metastases
    |
    CCR8 (C-C Motif Chemokine Receptor 8)
    |
    PD-L1 expression • CCR8 expression
    |
    Tevimbra (tislelizumab-jsgr) • BGB-A3055
    over1year
    First-in-human study of ABBV-514 as monotherapy and in combination with budigalimab in patients with advanced solid tumors (ESMO 2023)
    In dose expansion, patients with R/R non-small cell lung cancer will be enrolled in ABBV-514 monotherapy (N=12) and ABBV-514 + BDG (N=12) cohorts, and patients with R/R head and neck squamous cell carcinoma in an ABBV-514 + BDG (N=12) cohort. Enrollment initiated in November 2021, with 30 patients enrolled as of April 2023.
    Clinical • P1 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    CCR8 (C-C Motif Chemokine Receptor 8)
    |
    budigalimab (ABBV-181) • ABBV-514
    almost2years
    Study of GS-1811 Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=216, Recruiting, Gilead Sciences | N=158 --> 216 | Trial completion date: Feb 2025 --> Feb 2027 | Trial primary completion date: Feb 2024 --> Jun 2026
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Yutuo (zimberelimab) • denikitug (GS-1811)
    almost2years
    A Phase 1 Study of ZL-1218 in Subjects With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=60, Recruiting, Zai Lab (Hong Kong), Ltd.
    New P1 trial • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • ZL-1218
    almost2years
    Discovery of a Potent and Selective CCR8 Small Molecular Antagonist IPG7236 for the Treatment of Cancer. (PubMed, J Med Chem)
    IPG7236 alone or in combination with PD-1 antibody exhibited significant tumor suppression effects in the mouse xenograft model of human breast cancer. IPG7236 is a promising clinical candidate that targets CCR8 with excellent in vitro ADMET properties, pharmacokinetics, safety profiles, and in vivo efficacy.
    Journal
    |
    CCR8 (C-C Motif Chemokine Receptor 8)
    |
    IPG7236
    2years
    Study of SRF114 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=70, Recruiting, Surface Oncology | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    CHS-114
    over2years
    Study of SRF114 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=70, Not yet recruiting, Surface Oncology
    New P1/2 trial • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    CHS-114
    over2years
    HBM1022: an afucosylated anti-CCR8 antibody, depletes specifically tumor infiltrating Tregs and inhibits tumor growth with excellent safety profile in preclinical studies (SITC 2022)
    HBM1022 exhibits a potent antitumor activity as monotherapy and in combination with anti-PD (L)1 antibodies. HBM1022 has favorable pharmacokinetic properties and an excellent safety profile in cynomolgus monkey, which suggests a potential good safety profile in human.
    Preclinical • IO biomarker
    |
    CCR8 (C-C Motif Chemokine Receptor 8)
    |
    HBM1022
    3years
    Effective depletion of tumor-infiltrating Tregs by a novel anti-CCR8 antibody (LM-108): Addressing resistance associated with immune checkpoint inhibitors (AACR 2022)
    To conclude, LM-108 is a novel Fc-optimized CCR8 antibody that selectively depletes tumor infiltrating Tregs thereby improving anti-tumor immune response either as monotherapy or combination therapy. Thus, LM-108 can be a promising therapeutic approach to overcome ICI resistance in cancer patients.
    Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CCR4 (C-C Motif Chemokine Receptor 4) • FOXP3 (Forkhead Box P3) • CCR8 (C-C Motif Chemokine Receptor 8)
    |
    CCR8 expression • FOXP3 expression
    |
    cafelkibart (LM-108)
    3years
    ZL-1218, a novel anti-CCR8 antibody, exerts potent antitumor effect by depleting intratumoral regulatory T cells (AACR 2022)
    We are currently exploring the significance of these distinct populations and the impact of ZL-1218-mediated depletion of both CCR8 high- and CCR8 low-expressing subsets in multiple indications. Together, these data support the advancement of ZL-1218 into clinical evaluation as a novel therapeutic candidate to treat human solid tumors.
    PD(L)-1 Biomarker • IO biomarker
    |
    CD4 (CD4 Molecule) • FOXP3 (Forkhead Box P3) • CCR8 (C-C Motif Chemokine Receptor 8)
    |
    CCR8 expression
    |
    ZL-1218
    over3years
    Chemokines in the Landscape of Cancer Immunotherapy: How They and Their Receptors Can Be Used to Turn Cold Tumors into Hot Ones? (PubMed, Cancers (Basel))
    We also discuss the possibility of targeting the function or deleting a key subset of T that are CCR8 by monoclonal antibodies to CCR8. These cells are preferentially abundant in several tumors and are likely to be the key drivers in suppressing anti-cancer immune reactivity.
    Review • Journal
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • CCR8 (C-C Motif Chemokine Receptor 8) • CXCR3 (C-X-C Motif Chemokine Receptor 3)
    over3years
    Single-cell profiling defines the prognostic benefit of CD39 tissue resident memory CD8+ T cells in luminal-like breast cancer. (PubMed, Commun Biol)
    Nevertheless, such prognostic benefit is lost in the presence of highly-suppressive CCR8 ICOS IRF4+ effector Tregs. Thus, combinatorial strategies aiming at boosting Trm function and infiltration while relieving from Treg-mediated immunosuppression should be investigated to achieve proper tumor control in luminal-like BCs.
    Journal
    |
    CD8 (cluster of differentiation 8) • IL7R (Interleukin 7 Receptor) • ICOS (Inducible T Cell Costimulator) • CCR8 (C-C Motif Chemokine Receptor 8) • ENTPD1 (Ectonucleoside Triphosphate Diphosphohydrolase 1)