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TransCon TLR7/8 Agonist

DRUG6 trials

Sponsors

Ascendis Pharma Oncology Division A/S, Ascendis Pharma A/S

Conditions

2L+ Cervical CancerAdvanced Solid TumorCancerHPV-associated CancersHead and Neck NeoplasmsHead and Neck Squamous Cell Carcinoma HNSCCLocally Advanced Solid TumorLocally advanced or metastatic solid tumor malignancies

Phase 1

A Study of TransCon TLR7/8 Agonist With or Without Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors
TerminatedNCT04799054
Ascendis Pharma Oncology Division A/SAdvanced Solid Tumor, Head and Neck Squamous Cell Carcinoma HNSCC, HPV-associated Cancers +4
Start: 2021-03-18End: 2025-12-02Updated: 2026-01-20
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
Active, not recruitingNCT05081609
Ascendis Pharma Oncology Division A/S2L+ Cervical Cancer, Advanced Solid Tumor, Locally Advanced Solid Tumor +10
Start: 2022-01-11End: 2029-08-01Updated: 2026-02-24
IL Believe: A Phase 1/2, Open-Label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination with Pembrolizumab, TransCon TLR7/8 Agonist, or Other Anticancer Therapies, in Adult Participants with Locally Advanced or Metastatic Solid Tumor Malignancies
RecruitingCTIS2023-509143-27-00
Ascendis Pharma Oncology Division A/SLocally advanced or metastatic solid tumor malignancies, neoadjuvant melanoma and neoadjuvant non-small cell lung cancer, platinum resistant ovarian cancer +5
Start: 2023-11-27Target: 120Updated: 2025-12-26
Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study of TransCon TLR7/8 Agonist Alone or in Combination with Pembrolizumab in Participants with Locally Advanced or Metastatic Solid Tumor Malignancies
CompletedCTIS2024-517150-10-00
Ascendis Pharma Oncology Division A/SCancer
Start: 2023-06-29End: 2025-12-02Target: 53Updated: 2025-09-23

Phase 2

TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma
TerminatedNCT05980598
Ascendis Pharma A/SHead and Neck Neoplasms
Start: 2023-09-29End: 2025-03-28Updated: 2025-08-01
BelieveIT-201: A Randomized, Phase 2, Open-label Trial of TransCon TLR7/8 Agonist in Combination with Pembrolizumab, TransCon TLR7/8 Agonist in Combination with TransCon IL-2 β/γ, or Pembrolizumab Monotherapy as Neoadjuvant Therapy in Participants with Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)
CompletedCTIS2023-506092-10-00
Ascendis Pharma Oncology Division A/SStage III-IVA Resectable Locoregionall Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)
Start: 2024-03-11End: 2025-03-28Target: 43Updated: 2025-05-07

Related Papers

TransCon IL-2 β/γ alone or in combination with pembrolizumab, standard of care chemotherapy or TransCon TLR7/8 agonist in advanced/metastatic solid tumors: Updated results of the phase 1/2 IL Believe study.
Journal of Clinical Oncology2024-06-011 citations
Degradable Hydrogel for Sustained Localized Delivery of Anti-Tumor Drugs.
2023-06-046 citations
Phase 1/2 dose escalation and dose expansion study of TransCon IL-2 β/γ alone or in combination with pembrolizumab: Initial results from dose escalation.
Journal of Clinical Oncology2023-06-01
763 Phase 1/2 dose escalation and dose expansion study of transCon TLR7/8 agonist alone or in combination with pembrolizumab in patients with locally advanced or metastatic solid tumor malignancies: initial results from dose escalation
Regular and Young Investigator Award Abstracts2022-11-012 citations
Intratumoral delivery of TransCon<sup>™</sup> TLR7/8 Agonist promotes sustained anti-tumor activity and local immune cell activation while minimizing systemic cytokine induction.
2022-09-1927 citations
TransCon IL-2 β/γ: a novel long-acting prodrug with sustained release of an IL-2Rβ/γ-selective IL-2 variant with improved pharmacokinetics and potent activation of cytotoxic immune cells for the treatment of cancer
Journal for ImmunoTherapy of Cancer2022-07-0134 citations
Abstract CT252: transcendIT-101: A phase 1/2, open-label, dose escalation and dose expansion study of TransCon TLR7/8 Agonist alone or in combination with pembrolizumab in patients with locally advanced or metastatic solid tumors
Cancer Research2022-06-151 citations
IL believe: A phase 1/2, open-label, dose escalation and dose expansion study of TransCon IL-2 β/γ alone or in combination with pembrolizumab or standard-of-care chemotherapy in patients with locally advanced or metastatic solid tumors.
Journal of Clinical Oncology2022-06-01
TransCon IL-2 β/γ, a novel long-acting prodrug with sustained release of an IL-2Rβ/γ-selective IL-2 analog, demonstrates improved pharmacokinetics and profound expansion of cytotoxic immune cells in non-human primates.
Journal of Clinical Oncology2022-06-01
16 Tumor growth inhibition mediated by a single dose of intratumoral TransCon™ TLR7/8 agonist was associated with activated circulating T and B cells and sustained low levels of systemic cytokines
Regular and Young Investigator Award Abstracts2021-11-015 citations
769 A single dose of intratumoral TransCon™ TLR7/8 agonist monotherapy promoted sustained activation of antigen presenting cells resulting in CD4+ and CD8+ T cell activation and tumor growth inhibition
Regular and Young Investigator Award Abstracts2021-11-011 citations