eligibility_summary
Eligibility: adults (≥18) with path-confirmed advanced/metastatic solid tumor, after or ineligible for all standard therapies, measurable disease (RECIST 1.1), confirmed HLA, ECOG 0–1, adequate blood, liver, kidney, and coagulation function. Exclude: other active cancers needing therapy or interfering (adjuvant anti-hormonal allowed), pregnancy/breastfeeding, hypersensitivity to IMA402/rescue meds, severe/uncontrolled disease or safety/compliance concerns, active brain metastases.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: IMA402 monotherapy. Type/mechanism: IMA402 is a bispecific, TCR-based biological (TCER) that uses a high-affinity soluble TCR to recognize a PRAME-derived peptide presented by HLA class I on tumor cells while an anti-CD3 moiety engages T cells. This redirects and activates polyclonal T cells to mediate tumor cell lysis. Targets: PRAME (a tumor-associated/cancer-testis antigen) on solid tumors via its peptide–HLA complex, CD3 on T cells. Pathways engaged: TCR/CD3 signaling, immune synapse formation, with downstream perforin/granzyme-mediated cytotoxicity and cytokine release. Trial: Phase I/II dose escalation/extension assessing MTD/RDE, safety, PK, and anti-tumor activity in recurrent/refractory solid tumors, HLA status required.