NCT04799054

A Study of TransCon TLR7/8 Agonist With or Without Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Ascendis Pharma Oncology Division A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

TransCon TLR7/8 Agonist is an investigational drug being developed for treatment of locally advanced or metastatic solid tumors. This Phase 1/2 study will evaluate TransCon TLR7/8 Agonist as monotherapy or in combination with pembrolizumab in dose escalation and dose expansion. Participants will receive intratumoral (IT) injection of TransCon TLR7/8 Agonist every cycle. The primary objectives are to evaluate safety and tolerability, and define the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TransCon TLR7/8 Agonist alone or in combination with pembrolizumab.

Detailed description

Toll-like receptors (TLRs) are a class of proteins that play a key role in innate immune cell recognition of foreign pathogens, stimulating innate and adaptive immune responses. TransCon TLR7/8 Agonist is designed as a long-acting localized delivery prodrug of resiquimod, a potent toll-like receptor (TLR) 7/8 agonist, with the potential to prolong high local concentrations of resiquimod and promote potent anti-tumoral responses while reducing systemic drug exposure and related adverse events. TransCon TLR7/8 Agonist is expected to stimulate innate and adaptive immune response in the tumor microenvironment and enhance the activity of checkpoint inhibitors like pembrolizumab.

Conditions

• Advanced Solid Tumor
• Locally Advanced Solid Tumor
• Metastatic Solid Tumor
• Head and Neck Squamous Cell Carcinoma HNSCC
• HPV-associated Cancers
• Neoadjuvant Melanoma
• Neoadjuvant Cutaneous Squamous Cell Carcinoma (cSCC)

Interventions

Type	Name	Description
DRUG	TransCon TLR7/8 Agonist	TransCon TLR7/8 Agonist will be administered as an IT injection
DRUG	Pembrolizumab	Pembrolizumab will be administered IV

Timeline

• Start date: 2021-03-18
• Primary completion: 2025-12-02
• Completion: 2025-12-02
• First posted: 2021-03-16
• Last updated: 2026-04-13

Locations

49 sites across 6 countries: United States, Australia, Netherlands, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study