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

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.

Timeline

Start

2021-03-18

Primary completion

2025-12-02

Completion

2025-12-02

Outcome

Outcome not reported

Stopped (Enrollment): “The Sponsor made the decision to close enrollment to prioritize our efforts on TransCon IL-2 ß/g.”

Publications

• Lessmann T, Jones SA, Voigt T, Weisbrod S, Kracker O, Winter S, Zuniga LA, Stark S, Bisek N, Sprogoe K. Degradable Hydrogel for Sustained Localized Delivery of Anti-Tumor Drugs. J Pharm Sci. 2023 Nov;112(11):2843-2852. doi: 10.1016/j.xphs.2023.05.018. Epub 2023 Jun 4.
• Zuniga LA, Lessmann T, Uppal K, Bisek N, Hong E, Rasmussen CE, Karlsson JJ, Zettler J, Holten-Andersen L, Bang K, Thakar D, Lee YC, Martinez S, Sabharwal SS, Stark S, Faltinger F, Kracker O, Weisbrod S, Muller R, Voigt T, Bigott K, Tabrizifard M, Breinholt VM, Mirza AM, Rosen DB, Sprogoe K, Punnonen J. Intratumoral delivery of TransCon TLR7/8 Agonist promotes sustained anti-tumor activity and local immune cell activation while minimizing systemic cytokine induction. Cancer Cell Int. 2022 Sep 19;22(1):286. doi: 10.1186/s12935-022-02708-6.

Drugs

Indications