New drug FXB0871 takes on advanced cancers in first human trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Signed informed consent. * Age ≥18 years. * Histologically confirmed selected locally advanced or metastatic solid tumor with progression on, intolerance to, or no suitable standard therapy. * ECOG performance status 0 or 1. * At least one measurable lesion per RECIST v1.1. * Pretreatment tumor tissue available (archival or fresh biopsy). * Life expectancy ≥12 weeks. * Oxygen saturation ≥92% on room air. * Left ventricular ejection fraction \>50%. * Adequate hematologic, coagulation, renal, hepatic, and cardiac function. * Women of childbearing potential and sexually active men must use highly effective contraception. * Tumor-specific eligibility applies, including prior anti-PD-(L)1 treatment failure for the selected cohorts. Key Exclusion Criteria: * Systemic anti-cancer therapy, major surgery, or radical radiotherapy within 4 weeks before first dose. * Prior treatment with IL-2, IL-15, or IL-7. * Active autoimmune disease requiring systemic treatment or immunodeficiency. * Systemic corticosteroids (≥10 mg/day prednisone equivalent) or other immunosuppressive therapy within 28 days before first dose, with limited protocol-defined exceptions. * Active or untreated central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease. * Uncontrolled infection or clinically significant unresolved toxicities from prior therapy. * Clinically significant cardiovascular/cerebrovascular disease, uncontrolled effusions/ascites, uncontrolled hypertension, or QTcF \>470 ms. * Active hepatitis B/C, syphilis, or HIV infection. * Clinically significant interstitial lung disease or active noninfectious pneumonitis. * Pregnancy or breastfeeding. * Any other serious medical or psychiatric condition that, in the investigator's judgment, would make participation inappropriate.