^
    4d
    Phase I/II clinical trial of a melanoma vaccine targeting shared non-mutated antigens and a shared mutated BRAF neoantigen with an agonistic CD40 antibody (CDX-1140) plus TLR3 agonist (poly-ICLC). (PubMed, J Immunother Cancer)
    The vaccine was safe, well-tolerated, and immunogenic. Optimization of vaccines that include agonistic CD40 antibody is needed to enhance immunogenicity. Induction of a multifunctional CD4+ T cell response to mBRAF supports targeting shared mutated neoantigens with melanoma vaccines.
    P1/2 data • Journal • IO biomarker • First-in-human
    |
    BRAF (B-raf proto-oncogene) • CD8 (cluster of differentiation 8) • LAMP3 (Lysosomal Associated Membrane Protein 3) • CD40 (CD40 Molecule)
    |
    BRAF V600E • BRAF mutation • BRAF V600
    |
    CDX-1140 • Hiltonol (poly-ICLC)
    2ms
    1B-22-2: In Situ Immunomodulation With CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients w/ Unresectable and Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=14, Active, not recruiting, University of Southern California | Recruiting --> Active, not recruiting | Trial completion date: Jan 2027 --> Jan 2028 | Trial primary completion date: Jan 2026 --> Jan 2027
    Enrollment closed • Trial completion date • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • CDX-1140 • Hiltonol (poly-ICLC) • Mobista (CDX-301)
    3ms
    Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer (clinicaltrials.gov)
    P2, N=44, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Initiation date: Nov 2025 --> Aug 2026
    Enrollment open • Trial initiation date • IO biomarker
    |
    Libtayo (cemiplimab-rwlc) • CDX-1140
    3ms
    Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer (clinicaltrials.gov)
    P2, N=44, Not yet recruiting, National Cancer Institute (NCI) | Trial completion date: May 2027 --> Nov 2027 | Trial primary completion date: May 2027 --> Nov 2027
    Trial completion date • Trial primary completion date • IO biomarker
    |
    Libtayo (cemiplimab-rwlc) • CDX-1140
    4ms
    Hotspot TCR-T: A Phase I/Ib Study of Adoptively Transferred T-cell Receptor Gene-engineered T Cells (TCR-T) (clinicaltrials.gov)
    P1, N=24, Active, not recruiting, Providence Health & Services | Trial primary completion date: Aug 2025 --> Dec 2025
    Trial primary completion date
    |
    CD4 (CD4 Molecule)
    |
    Keytruda (pembrolizumab) • CDX-1140
    8ms
    Hotspot TCR-T: A Phase I/Ib Study of Adoptively Transferred T-cell Receptor Gene-engineered T Cells (TCR-T) (clinicaltrials.gov)
    P1, N=24, Active, not recruiting, Providence Health & Services | Trial primary completion date: Feb 2025 --> Aug 2025
    Trial primary completion date
    |
    CD4 (CD4 Molecule)
    |
    Keytruda (pembrolizumab) • CDX-1140
    10ms
    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 2025 --> Apr 2026 | Trial primary completion date: Apr 2025 --> Apr 2026
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 negative
    |
    PD-L1 IHC 22C3 pharmDx
    |
    pegylated liposomal doxorubicin • CDX-1140 • Mobista (CDX-301)
    1year
    1B-22-2: In Situ Immunomodulation with CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients W/ Unresectable and Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=18, Recruiting, University of Southern California | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Jan 2025 --> Jan 2026
    Trial completion date • Trial primary completion date • Immunomodulating • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Keytruda (pembrolizumab) • CDX-1140 • Hiltonol (poly-ICLC) • Mobista (CDX-301)
    over1year
    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 | Enrolling by invitation --> Active, not recruiting | N=24 --> 1
    Enrollment closed • Enrollment change
    |
    CD4 (CD4 Molecule)
    |
    Keytruda (pembrolizumab) • CDX-1140
    over1year
    Mel66: Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma (Including Ocular Melanoma) (clinicaltrials.gov)
    P1/2, N=22, Completed, Craig L Slingluff, Jr | Active, not recruiting --> Completed | Trial completion date: May 2025 --> Mar 2024 | Trial primary completion date: Sep 2024 --> Mar 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene) • CD4 (CD4 Molecule)
    |
    CDX-1140 • Hiltonol (poly-ICLC)
    over1year
    CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer (clinicaltrials.gov)
    P1; N=45 --> 30
    Combination therapy • Enrollment change • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx
    |
    pegylated liposomal doxorubicin • CDX-1140 • Mobista (CDX-301)
    almost2years
    A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC) (clinicaltrials.gov)
    P1/2, N=60, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    Keytruda (pembrolizumab) • capecitabine • oxaliplatin • CDX-1140