Stopped: The Sponsor made the decision to close enrollment to prioritize our efforts on TransCon IL-2 ß/g.
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.
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Safety and Tolerability
Timeframe: Through study completion, expected average of 2 years
Maximum Tolerated Dose (MTD)
Timeframe: Cycle 1 (each cycle is 21 days) in Part 1 (monotherapy dose escalation) and Cycle 1 (the first cycle is 28 days and 21 days thereafter) in Part 2 (combination therapy dose escalation)
Recommended Phase 2 Dose (RP2D)
Timeframe: 12 months
Response
Timeframe: 9 weeks