A First-in-human, Open-label Trial to Evaluate the Combination of ACTengine® IMA203 With mRNA-4203 in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma or Synovial Sarcoma Patients (ACTengine® IMA203-102)
This purpose of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA203 in combination with different doses of mRNA-4203. The trial includes participants with previously treated unresectable or metastatic cutaneous melanoma (CM) or synovial sarcoma (SS).
• Pathologically confirmed and documented cutaneous melanoma (CM) or synovial sarcoma (SS) with unresectable or metastatic disease
• HLA-A\*02:01 positive
• Adequate selected organ function per protocol
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
• Life expectancy more than 5 months
• CM participants who must have disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor
• SS participants must have received (or declined) at least one line of treatment (including SoC) and are still in need of further systemic therapy.
• Female participants of childbearing potential must use adequate contraception prior to trial entry until 12 months after the infusion of IMA203 and 15 days after the last mRNA 4203 dose administration
⁃ Other protocol defined inclusion criteria could apply