^
    2d
    Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer (clinicaltrials.gov)
    P1, N=300, Enrolling by invitation, M.D. Anderson Cancer Center | Recruiting --> Enrolling by invitation
    Enrollment status
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    Keytruda (pembrolizumab) • Zyclara (imiquimod) • sotigalimab (PYX-107)
    2d
    STU-2021-0657: CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer (clinicaltrials.gov)
    P1, N=30, Recruiting, University of Texas Southwestern Medical Center | Trial completion date: Apr 2026 --> Apr 2029 | Trial primary completion date: Apr 2026 --> Apr 2028
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HR positive • HER-2 negative • PD-L1 negative
    |
    PD-L1 IHC 22C3 pharmDx • HercepTest
    |
    pegylated liposomal doxorubicin • CDX-1140 • Mobista (CDX-301)
    8d
    A Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma (RCC) (clinicaltrials.gov)
    P1, N=26, Completed, Yale University | Active, not recruiting --> Completed | Trial completion date: Aug 2026 --> Mar 2026
    Trial completion • Trial completion date
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • sotigalimab (PYX-107)
    16d
    A Study of FG-B901 Monotherapy or Combination With Chemotherapy in Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=264, Not yet recruiting, FutureGen Biopharmaceutical (Beijing) Co., Ltd
    New P1/2 trial
    1m
    Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy (clinicaltrials.gov)
    P1, N=66, Completed, Lyvgen Biopharma Holdings Limited | Active, not recruiting --> Completed | N=126 --> 66
    Trial completion • Enrollment change • First-in-human
    |
    dalnicastobart (LVGN7409) • exlinkibart (LVGN6051) • pradusinstobart (LVGN3616)
    1m
    Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment (clinicaltrials.gov)
    P1, N=55, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Nov 2026 --> Nov 2027 | Trial primary completion date: Nov 2026 --> Nov 2027
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • 2141-V11
    1m
    Window Study of Intratumoral Mitazalimab in Breast Cancer (WINIT-BC) (clinicaltrials.gov)
    P1, N=32, Recruiting, Jennifer Zhang | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    Opdivo (nivolumab) • mitazalimab (ADC-1013)
    1m
    INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer (clinicaltrials.gov)
    P2, N=58, Completed, University of Texas Southwestern Medical Center | Active, not recruiting --> Completed
    Trial completion
    |
    oxaliplatin • sotigalimab (PYX-107)
    2ms
    Tumor-localized CD40 agonism with MP0317, a FAP x CD40 DARPin, reprograms the tumor microenvironment in patients with advanced solid tumors: an open-label, nonrandomized, dose-escalation phase 1 study. (PubMed, Nat Cancer)
    Collectively, these data confirm a favorable safety profile for MP0317 and support further clinical evaluation in combination with complementary immunotherapies. ClinicalTrials.gov registration: NCT05098405 .
    P1 data • Journal • IO biomarker
    |
    IFNG (Interferon, gamma) • CD40 (CD40 Molecule)
    |
    MP0317
    2ms
    Safety and activity of RO7300490, a bispecific CD40 agonist targeted to fibroblast activation protein, in patients with advanced solid tumors: a single-arm, multicenter, first-in-human, phase 1 trial. (PubMed, Nat Cancer)
    In summary, treatment with a tumor-targeted CD40 agonist antibody is feasible, clinically manageable and induces immunomodulation of the tumor microenvironment. ClinicalTrials.gov registration: NCT04857138 .
    P1 data • Journal • First-in-human
    |
    LAMP3 (Lysosomal Associated Membrane Protein 3) • CD40 (CD40 Molecule)
    2ms
    Personalized TCR-T: Study of Adoptively Transferred T-cell Receptor Gene-engineered T Cells (TCR-T) (clinicaltrials.gov)
    P1, N=1, Active, not recruiting, Providence Health & Services | Trial primary completion date: Apr 2026 --> Apr 2027
    Trial primary completion date
    |
    CD4 (CD4 Molecule)
    |
    Keytruda (pembrolizumab) • CDX-1140
    2ms
    Intratumoral sotigalimab with pembrolizumab induces rapid activation of antigen presenting cells and drives anti-tumor responses in non-injected tumors in metastatic melanoma: A phase I/II study. (PubMed, Cancer Discov)
    TCR sequencing showed increased T-cell clonality with expanded new clones shared across tumors. Clinical responses correlated with these immunologic changes, but not with baseline features associated with response to anti-PD1 monotherapy.
    P1/2 data • Journal
    |
    LAMP3 (Lysosomal Associated Membrane Protein 3) • ITGAX (Integrin Subunit Alpha X)
    |
    Keytruda (pembrolizumab) • sotigalimab (PYX-107)