eligibility_summary
Inclusion: Adults ≥18 with relapsed/refractory MM after ≥3 prior agents (PI, IMiD, anti‑CD38), measurable disease, ECOG 0–2, WOCBP negative test and contraception. Exclusion: allergy, plasma cell leukemia, amyloidosis, CNS MM, POEMS, strong CYP3A4 drugs, recent anti‑MM therapy, transplant, or major surgery, significant eye disease, ≥G3 neuropathy, unresolved AEs, cytopenias, CrCl<30, hepatic dysfunction, serious CV disease, COPD/asthma/ILD, active infection or HBV/HCV/HIV, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT05565807 tests STI-6129, an anti-CD38 antibody–drug conjugate (biologic). The human anti-CD38 (A2) monoclonal antibody is covalently linked to a duostatin payload (a dolastatin/auristatin-like tubulin inhibitor). Mechanism: STI-6129 binds CD38 on multiple myeloma plasma cells, is internalized, and releases duostatin to disrupt microtubules, causing mitotic arrest and apoptosis, the antibody may also mediate immune effector functions (ADCC/CDC). Targets: CD38-expressing malignant plasma cells, pathways affected include microtubule dynamics and cell-cycle (mitosis). Design: Phase Ib/IIa open-label dose escalation/expansion (IV every 4 weeks, 0.25–3.68 mg/kg) in relapsed/refractory multiple myeloma previously treated with a PI, IMiD, and an anti‑CD38 antibody, to determine RP2D and assess preliminary efficacy.