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A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer

Published: July 22, 2022

Primary Outcome Measures

  1. Phase 1 – Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events. [ Time Frame: DLTs within 28 days post-treatment ]
    Phase 1 -The number and percent of patients in the DLT evaluable set who experienced DLTs from the first administration of study drug up to 28 days post study drug treatment will be summarized by dosing group
  2. Phase 2 – Overall Response Rate (ORR) [ Time Frame: Up to 2 years post-treatment ]
    ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1
  3. Phase 2 – Disease Control Rate (DCR) [ Time Frame: Up to 2 years post-treatment ]
    DCR defined as a composite of ORR and stable disease (SD) lasting at least 8 weeks.

Inclusion Criteria

  • Patient is > 18 years of age at the time the Informed Consent is signed.
  • Patient has a pathologically confirmed diagnosis of either MPM, Serous Ovarian Adenocarcinoma, Pancreatic Adenocarcinoma, TNBC, and Colorectal Cancer
  • Patient’s tumor has been reviewed with confirmed positive MSLN expression on >/= 50% of tumor cells that are 1+, 2+ and/or 3+ by immunohistochemistry.
  • Prior to TC-510 infusion, patients must have received at least 1 but no more than 5 systemic therapies for metastatic or unresectable disease with more details provided in the protocol
  • Patients has an ECOG performance status 0 or 1
  • Patient is fit for leukapheresis and has adequate venous access for the cell collection.
  • Patient must have adequate organ function as indicated by the laboratory values in the clinical protocol

Exclusion Criteria

  • Inability to follow the procedures of the study
  • Known or suspected non-compliance, drug, or alcohol use
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