IMA401 TCER® in Recurrent and/or Refractory Solid Tumors, Alone or in Combination With a Checkpoint Inhibitor
Trial Parameters
Brief Summary
The goal of this clinical trial is to evaluate the safety, tolerability and initial anti-tumor activity of IMA401 as monotherapy or in combination with checkpoint inhibitor in patients with recurrent and/or refractory solid tumors. Patients' HLA status and expression of the MAGE-A4 and/or MAGE-A8 target in the tumor must be confirmed. Primary objective: * To determine the maximum tolerated dose and/or recommended dose for extension for IMA401 as monotherapy and in combination with pembrolizumab Secondary objectives: * To characterize the safety and tolerability of IMA401 as monotherapy and in combination with pembrolizumab * To evaluate initial anti-tumor activity of IMA401 as monotherapy and in combination with pembrolizumab * To describe the pharmacokinetics of IMA401 as monotherapy and in combination with pembrolizumab
Eligibility Criteria
Inclusion Criteria: * Patients must have voluntarily signed a written ICF, be able to understand and comply with clinical trial procedures * Patients ≥ 18 years old * Patients must have pathologically confirmed and documented advanced and/or metastatic NSCLC or HNSCC, other solid tumor may be considered * Confirmed HLA status and IMA401 tumor target MAGE-A4 and/or MAGE-A8 expression * Life expectancy \> 2 months * ECOG Performance Status of 0 to 1 * Measurable disease according to RECIST 1.1 * Adequate baseline hematologic, renal and hepatic function; acceptable coagulation status * Patients must have recurrent and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatments * The patient must have recovered from any side effects of prior therapy to Grade 1 or lower (except for non-clinically significant toxicities; e.g., alopecia, vitiligo) prior to treatment start. As determined by the investigator, the patient may still