eligibility_summary
Eligible: metastatic or unresectable solid tumors that are PRAME+, HLA-A02:01+, ECOG 0-1, after exhausting/intolerant of standard therapy, use effective contraception if of childbearing potential. Exclude: active/untreated CNS mets, recent GI obstruction/perforation/fistula, ongoing ascites/effusions needing drainage, significant toxicities, abnormal labs, lung/heart/autoimmune disease, need immunosuppression, second malignancy, drug hypersensitivity, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT07156136 tests IMC-P115C, a half-life–extended ImmTAC (TCR-based bispecific biologic) as monotherapy (with planned combinations). Mechanism: a soluble, high-affinity TCR specifically binds PRAME peptide presented by HLA‑A02:01 on tumor cells, fused to an anti‑CD3 effector that recruits and activates polyclonal T cells. This redirects cytotoxic T cells to PRAME+ cancer cells, forming an immune synapse and triggering TCR–CD3 signaling, cytokine release, and tumor cell lysis. Targets/pathways: PRAME antigen on HLA-A02:01 (tumor MHC I), CD3 on T cells, TCR signaling and cytotoxic effector pathways. Population: advanced PRAME+ solid tumors, HLA-A02:01-positive.