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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
Ascendis Pharma Oncology Division A/S
This is a non-randomised, open-label trial deigned to evaluate a new investigational drug (TransCon TLR7/8 Agonist) as monotherapy or in combination with pembrolizumab in dose escalation and dose expansion. Participants will receive an intratumoral (IT) injection of TransCon TLR7/8 Agonist every cycle. In Part 1 (Dose Escalation), participants will receive TransCon TLR7/8 Agonist monotherapy in escalating doses to evaluate safety and tolerability and to determine the MTD and RP2D. In Part 2 (dose escalation), participants will receive TransCon TLR7/8 Agonist in combination with pembrolizumab (administered intravenously [IV]) to evaluate safety/tolerability and determine the MTD and RP2D. In Part 3 (Dose Expansion), participants will receive TransCon TLR7/8 Agonist in combination with pembrolizumab using the RP2D from part 2 to evaluate the safety/tolerability and anti-tumour activity of the combined treatment.