^
    4ms
    BelieveIT-201: TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=27, Terminated, Ascendis Pharma A/S | Trial primary completion date: Dec 2024 --> Mar 2025
    Trial primary completion date
    |
    Keytruda (pembrolizumab) • onvapegleukin alfa (TransCon IL-2 β/γ) • resiquimod SR (TransCon TLR7/8 Agonist)
    5ms
    BelieveIT-201: TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=27, Terminated, Ascendis Pharma A/S | Completed --> Terminated; The Sponsor made the decision to close enrollment as part of a strategic portfolio review.
    Trial termination
    |
    Keytruda (pembrolizumab) • onvapegleukin alfa (TransCon IL-2 β/γ) • resiquimod SR (TransCon TLR7/8 Agonist)
    6ms
    transcendIT-101: A Study of TransCon TLR7/8 Agonist With or Without Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=188, Active, not recruiting, Ascendis Pharma Oncology Division A/S | Trial primary completion date: May 2025 --> Jan 2026
    Trial primary completion date
    |
    Keytruda (pembrolizumab) • resiquimod SR (TransCon TLR7/8 Agonist)
    7ms
    BelieveIT-201: TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=27, Completed, Ascendis Pharma A/S | Active, not recruiting --> Completed | Trial completion date: Jul 2027 --> Mar 2025 | Trial primary completion date: Apr 2025 --> Dec 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • onvapegleukin alfa (TransCon IL-2 β/γ) • resiquimod SR (TransCon TLR7/8 Agonist)
    1year
    BelieveIT-201: TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=27, Active, not recruiting, Ascendis Pharma A/S | Recruiting --> Active, not recruiting | N=92 --> 27
    Enrollment closed • Enrollment change • Combination therapy • Surgery • Metastases
    |
    Keytruda (pembrolizumab) • onvapegleukin alfa (TransCon IL-2 β/γ) • resiquimod SR (TransCon TLR7/8 Agonist)
    1year
    transcendIT-101: A Study of TransCon TLR7/8 Agonist With or Without Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=188, Active, not recruiting, Ascendis Pharma Oncology Division A/S | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • resiquimod SR (TransCon TLR7/8 Agonist)
    1year
    IL Believe: A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies (clinicaltrials.gov)
    P1/2, N=473, Recruiting, Ascendis Pharma Oncology Division A/S | Trial completion date: Aug 2027 --> Aug 2029 | Trial primary completion date: May 2026 --> Aug 2027
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    IL2 (Interleukin 2)
    |
    Keytruda (pembrolizumab) • Kadcyla (ado-trastuzumab emtansine) • onvapegleukin alfa (TransCon IL-2 β/γ) • resiquimod SR (TransCon TLR7/8 Agonist)
    almost2years
    IL Believe: A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or Chemotherapy or TransCon TLR7/8 Agonist in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies (clinicaltrials.gov)
    P1/2, N=393, Recruiting, Ascendis Pharma Oncology Division A/S | Trial completion date: May 2025 --> Aug 2027 | Trial primary completion date: Jan 2025 --> May 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    IL2 (Interleukin 2)
    |
    Keytruda (pembrolizumab) • onvapegleukin alfa (TransCon IL-2 β/γ) • resiquimod SR (TransCon TLR7/8 Agonist)
    2years
    transcendIT-101: A Study of TransCon TLR7/8 Agonist With or Without Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=220, Recruiting, Ascendis Pharma Oncology Division A/S
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • resiquimod SR (TransCon TLR7/8 Agonist)
    2years
    BelieveIT-201: TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=92, Recruiting, Ascendis Pharma Oncology Division A/S | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Surgery • Metastases
    |
    Keytruda (pembrolizumab) • resiquimod SR (TransCon TLR7/8 Agonist)
    over2years
    Degradable hydrogel for sustained localized delivery of anti-tumor drugs. (PubMed, J Pharm Sci)
    Resiquimod, a TLR7/8 agonist, and axitinib, a vascular endothelial growth factor tyrosine kinase inhibitor, were chosen as anti-cancer drugs. In summary, TransCon Hydrogel technology allows localized sustained-release drug delivery for cancer therapy enabling high local drug concentrations while at the same time ensuring low systemic drug exposure over weeks with a single injection, which may improve the therapeutic index and improve efficacy, while minimizing systemic adverse events. A hydrogel prodrug of resiquimod, TransCon TLR7/8 agonist, is currently being investigated in clinical trials of patients with solid tumors (NCT04799054).
    Journal
    |
    Inlyta (axitinib) • resiquimod (STM-416) • resiquimod SR (TransCon TLR7/8 Agonist)
    3years
    IL Believe: A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or Chemotherapy or TransCon TLR7/8 Agonist in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies (clinicaltrials.gov)
    P1/2, N=317, Recruiting, Ascendis Pharma Oncology Division A/S | N=86 --> 317
    Enrollment change • Combination therapy • Metastases
    |
    IL2 (Interleukin 2)
    |
    Keytruda (pembrolizumab) • resiquimod SR (TransCon TLR7/8 Agonist)