A Clinical Study of Intravenous T3011 Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors

Summary

Participation Requirements

Description

This is a Phase 1/2a, open-label, first-in-human study of T3011 given via intravenous (IV) infusion as a single agent and in combination with IV pembrolizumab in participants with advanced or metastatic solid tumors. The Phase 1 Part A portion of the study is a single agent dose escalation which wil...

This is a Phase 1/2a, open-label, first-in-human study of T3011 given via intravenous (IV) infusion as a single agent and in combination with IV pembrolizumab in participants with advanced or metastatic solid tumors. The Phase 1 Part A portion of the study is a single agent dose escalation which will use a 3+3 design to evaluate escalating doses of T3011. Total enrollment will depend on the toxicities and/or activity observed, with approximately 24 evaluable participants enrolled. Once the IV T3011 RP is established, the Phase 1 Part B part of the study will begin. Phase 1 Part B is IV T3011 in combination with IV pembrolizumab dose escalation which will use a 3+3 design to evaluate escalating doses of IV T3011 in combination with IV pembrolizumab. Total enrollment will depend on the toxicities and/or activity observed, with approximately 18 evaluable participants enrolled. Upon completion of Phase 1 Part B, Phase 2a will begin. The safety, tolerability, and preliminary efficacy of IV T3011 given in combination with IV pembrolizumab will be evaluated in 15 participants with histologically or pathologically confirmed metastatic NSCLC (Arm A) and 15 participants with advanced solid tumors with metastasis in either the liver and/or lung (Arm B).

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