^
    19h
    KYANITE-1: A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs (clinicaltrials.gov)
    P1/2, N=140, Recruiting, Krystal Biotech, Inc. | Phase classification: P1 --> P1/2 | N=80 --> 140
    Phase classification • Enrollment change
    |
    Keytruda (pembrolizumab)
    20h
    OPAL-1: A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=140, Recruiting, Krystal Biotech, Inc. | Phase classification: P1 --> P1/2 | N=80 --> 140
    Phase classification • Enrollment change
    |
    Opdualag (nivolumab/relatlimab-rmbw)
    3d
    Descartes-25 in Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=9, Terminated, Cartesian Therapeutics | Active, not recruiting --> Terminated; Phase 1 enrollment completed. Further clinical development terminated.
    Trial termination
    14d
    XTX301-01: XTX301 in Patients with Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=358, Recruiting, Xilio Development, Inc. | Phase classification: P1 --> P1/2 | N=174 --> 358
    Phase classification • Enrollment change • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    XTX301
    18d
    CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2) (clinicaltrials.gov)
    P1, N=16, Terminated, Providence Health & Services | Completed --> Terminated; Study was ended prematurely due to lack of efficacy. As per FDA guidance, our site continued to follow enrolled subjects through the 180 day safety visit.
    Trial termination
    |
    Tavo (tavokinogene telsaplasmid)
    28d
    Neoadjuvant intratumoral plasmid interleukin-12 electro-gene-transfer and nivolumab in patients with operable locoregionally advanced melanoma. (PubMed, Clin Cancer Res)
    The clinical efficacy of neoadjuvant IT TAVO-EP + nivolumab is promising with 80% of patients achieving an MPR. Evidence of potent immune activation both systemically and within the TME along with a favorable safety profile supports the activity of local IL-12 and anti-PD1 based regimens.
    Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
    |
    PD-L1 expression • CD8 expression • IFNG expression
    |
    Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    1m
    Phase 1/2 Clinical Study of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=258, Not yet recruiting, Sichuan Huiyu Pharmaceutical Co., Ltd
    New P1/2 trial • Metastases
    1m
    INO 5401 Vaccination in BRCA1/2 Mutation Carriers (clinicaltrials.gov)
    P1, N=44, Recruiting, University of Pennsylvania | Phase classification: P1b --> P1
    Phase classification
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation
    |
    INO-5401 • rocakinogene sifuplasmid (INO-9012)
    1m
    Study of VG2025 Delivered Intraperitoneally in Patients with Advanced Solid Tumors with Carcinomatosis (clinicaltrials.gov)
    P1, N=0, Withdrawn, M.D. Anderson Cancer Center | N=21 --> 0 | Trial completion date: Mar 2030 --> Oct 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Mar 2028 --> Oct 2024
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • Metastases
    |
    VG201
    1m
    M032-HSV-1: Genetically Engineered HSV-1 Phase 1 Study for the Treatment of Recurrent Malignant Glioma (clinicaltrials.gov)
    P1, N=29, Active, not recruiting, University of Alabama at Birmingham | Trial completion date: Sep 2024 --> Sep 2025
    Trial completion date
    2ms
    STEALTH-001: A Study of VET3-TGI in Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=60, Recruiting, KaliVir Immunotherapeutics | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab)
    2ms
    Study of IMNN-001 (also Known As GEN-1) with NACT for Treatment of Ovarian Cancer (OVATION 2) (clinicaltrials.gov)
    P1/2, N=130, Active, not recruiting, Imunon | Trial completion date: Dec 2024 --> Nov 2025
    Trial completion date • Combination therapy • Metastases
    |
    carboplatin • paclitaxel • IMNN-001
    2ms
    Clinical Study of VG161 in Subjects with Advanced Primary Liver Cancer (clinicaltrials.gov)
    P1, N=44, Recruiting, CNBG-Virogin Biotech (Shanghai) Ltd. | Trial completion date: Dec 2022 --> Dec 2024
    Trial completion date • Metastases
    |
    VG161
    3ms
    A Study of XmAb®662 as Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=7, Terminated, Xencor, Inc. | N=210 --> 7 | Trial completion date: Sep 2030 --> May 2024 | Recruiting --> Terminated | Trial primary completion date: Sep 2028 --> May 2024; The Sponsor made a business decision to end the study.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab)
    3ms
    T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination With the Immunocytokine M9241 in Localized High- and Intermediate-Risk Prostate Cancer Treated With Androgen Deprivation Therapy (clinicaltrials.gov)
    P2, N=65, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Aug 2025 --> Aug 2026
    Trial completion date • Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    PDS01ADC
    3ms
    T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination With the Immunocytokine M9241 in Localized High- and Intermediate-Risk Prostate Cancer Treated With Androgen Deprivation Therapy (clinicaltrials.gov)
    P2, N=65, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Aug 2024 --> Aug 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    PDS01ADC
    4ms
    TG6050, an oncolytic vaccinia virus encoding interleukin-12 and anti-CTLA-4 antibody, favors tumor regression via profound immune remodeling of the tumor microenvironment. (PubMed, J Immunother Cancer)
    TG6050 effectively delivers functional IL-12 and @CTLA-4 into the tumor, resulting in strong antitumor activity. The shift towards an inflamed TME correlated with a boost in systemic antitumor T cells. The solid preclinical data and favorable benefit/risk ratio paved the way for the clinical evaluation of TG6050 in metastatic non-small cell lung cancer (NCT05788926 trial in progress).
    Journal • Oncolytic virus • IO biomarker
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    TG6050
    4ms
    Cyclophosphamide Followed by Intravenous and Intraperitoneal Infusion of Autologous T Cells Genetically Engineered to Secrete IL-12 and to Target the MUC16ecto Antigen in Patients With Recurrent MUC16ecto+ Solid Tumors (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Aug 2024 --> Aug 2025
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    cyclophosphamide • fludarabine IV • JCAR020
    4ms
    PuMP: Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of the Oncolytic HSV1 MVR-C5252 (clinicaltrials.gov)
    P1, N=51, Recruiting, Duke University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    MVR-C5252
    4ms
    Preliminary results from a phase I study of T3011, an oncolytic HSV expressing IL-12 and anti-PD-1 antibody, for BCG-failure non-muscle-invasive bladder cancer (NMIBC) (ESMO 2024)
    Intravesical T3011 demonstrates a promising anti-tumor efficacy and an excellent safety profile in patients with high risk BCG-failure NMIBC.
    P1 data
    |
    IFNG (Interferon, gamma)
    |
    UroVysion™ Bladder Cancer Kit (UroVysion Kit)
    |
    T3011
    4ms
    A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers (clinicaltrials.gov)
    P1/2, N=107, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Jun 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    Jingzhuda (entinostat) • bintrafusp alfa (M7824) • PDS01ADC
    4ms
    DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers (clinicaltrials.gov)
    P2, N=41, Terminated, M.D. Anderson Cancer Center | N=77 --> 41 | Active, not recruiting --> Terminated; Project delays
    Enrollment change • Trial termination • Metastases
    |
    CD4 (CD4 Molecule)
    |
    Imfinzi (durvalumab) • MEDI0457
    5ms
    20-C-0012: Bintrafusp Alfa (M7824) and NHS-IL12 (M9241) Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies (clinicaltrials.gov)
    P1, N=100, Recruiting, National Cancer Institute (NCI) | N=66 --> 100
    Enrollment change • Combination therapy • Metastases
    |
    CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • PDS01ADC
    5ms
    SERIL: A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 (SElf-Replicating RNA IL-12) Intratumoral Injection in Patients With Recurrent or Progressive High-Grade Glioma (clinicaltrials.gov)
    P1, N=21, Not yet recruiting, Duke University
    New P1 trial
    5ms
    Descartes-25 in Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=9, Active, not recruiting, Cartesian Therapeutics | Recruiting --> Active, not recruiting | Phase classification: P1/2 --> P1 | N=20 --> 9
    Enrollment closed • Phase classification • Enrollment change
    5ms
    A Study of MEDI9253 in Combination With Durvalumab in Select Solid Tumors (clinicaltrials.gov)
    P1, N=40, Completed, AstraZeneca | Active, not recruiting --> Completed | Trial completion date: Nov 2024 --> May 2024 | Trial primary completion date: Nov 2024 --> May 2024
    Trial completion • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Imfinzi (durvalumab) • MEDI9253
    5ms
    CLN-617 retains IL-2 and IL-12 in injected tumors to drive robust and systemic immune-mediated antitumor activity. (PubMed, Cancer Immunol Res)
    However, the only approved human IL-2 therapy, Proleukin, is rarely used in the clinic due to systemic toxicities, and no IL-12 product has been approved to date due to severe dose-limiting toxicities. We found that IT administration of a murine surrogate of CLN-617, mCLN-617, eradicated established treated and untreated tumors in syngeneic models, significantly improved response to anti-PD1 checkpoint therapy, and generated a robust abscopal response dependent on cellular immunity and antigen cross-presentation. CLN-617 is being evaluated in a clinical trial in patients with advanced solid tumors (NCT06035744).
    Journal
    |
    IL2 (Interleukin 2)
    |
    Proleukin (aldesleukin) • CLN-617
    5ms
    STEALTH-001: A Study of VET3-TGI in Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=60, Not yet recruiting, KaliVir Immunotherapeutics
    New P1 trial • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab)
    6ms
    Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Jul 2025 --> Jun 2028 | Trial primary completion date: Jul 2023 --> Jun 2028
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    6ms
    Clinical Study of T3011 Intravesical Instillation for Treatment of NMIBC Patients (clinicaltrials.gov)
    P1, N=20, Recruiting, Fudan University
    New P1 trial
    |
    T3011
    6ms
    KEYNOTE-B26: A Study of an Intratumoral Oncolytic Virus in Patients With Advanced Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=72, Completed, Astellas Pharma Global Development, Inc. | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Oncolytic virus • Metastases
    |
    Keytruda (pembrolizumab)
    6ms
    INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM) (clinicaltrials.gov)
    P1/2, N=52, Active, not recruiting, Inovio Pharmaceuticals | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    temozolomide • Libtayo (cemiplimab-rwlc) • INO-5401 • rocakinogene sifuplasmid (INO-9012)
    6ms
    ANCHOR: Phase I Study of ANK-101 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=92, Recruiting, Ankyra Therapeutics, Inc | N=46 --> 92
    Enrollment change • Metastases
    6ms
    STX-001-01: Study of IT STX-001 in Patients With Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab (clinicaltrials.gov)
    P1/2, N=108, Recruiting, Strand Therapeutics Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab)
    6ms
    Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Feb 2025 --> Jul 2025 | Trial primary completion date: Feb 2025 --> Jul 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    LDH elevation
    |
    Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    7ms
    Enhanced therapeutic efficacy for glioblastoma immunotherapy with an oncolytic herpes simplex virus armed with anti-PD-1 antibody and IL-12. (PubMed, Mol Ther Oncol)
    Moreover, syngeneic mouse models showed that the murine surrogate of C5252 has superior anti-tumor activity compared to the unarmed backbone virus, with enhanced immune activation. Taken together, our findings support C5252 as a promising therapeutic option for glioblastoma treatment, positioning it as a highly promising candidate for clinical translation.
    Journal
    |
    CASP3 (Caspase 3) • CASP7 (Caspase 7) • CNTFR (Ciliary Neurotrophic Factor Receptor)
    |
    MVR-C5252
    7ms
    INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma (clinicaltrials.gov)
    P1/2, N=35, Active, not recruiting, Inovio Pharmaceuticals | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Tecentriq (atezolizumab) • INO-5401 • rocakinogene sifuplasmid (INO-9012)
    7ms
    Enzalutamide and M9241 in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy (clinicaltrials.gov)
    P2, N=55, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Xtandi (enzalutamide capsule) • PDS01ADC
    7ms
    A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers (clinicaltrials.gov)
    P1/2, N=107, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Dec 2025
    Trial completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    PD-L1 negative
    |
    Jingzhuda (entinostat) • bintrafusp alfa (M7824) • PDS01ADC
    7ms
    Phase 1 Study of SON-1010 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=36, Recruiting, Sonnet BioTherapeutics | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial primary completion date • Metastases
    |
    SON-1010
    7ms
    Mediation of antitumor activity by AZD4820 oncolytic vaccinia virus encoding IL-12. (PubMed, Mol Ther Oncol)
    AZD4820 treatment combined with anti-PD-L1 blocking antibody augmented tumor-specific T cell immunity relative to monotherapies. These findings suggest that vaccinia virus delivery of IL-12, combined with immune checkpoint blockade, elicits antitumor immunity in tumors that respond poorly to immune checkpoint inhibitors.
    Journal • Oncolytic virus • PD(L)-1 Biomarker • IO biomarker
    |
    IFNG (Interferon, gamma)
    7ms
    DODEKA: Safety and Early Signs of Efficacy of IL12-L19L19. (clinicaltrials.gov)
    P1, N=94, Recruiting, Philogen S.p.A. | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    dodekin (F8-IL12)