A Phase 1/2, first-in-human, two-part, open-label clinical trial of intravenous administration of CTL-002 given as monotherapy and/or in combination with an anti-PD-1 checkpoint inhibitor in subjects with advanced-stage, relapsed/refractory solid tumors.

ADVANCED-STAGE, RELAPSED/REFRACTORY SOLID TUMORS

Evaluation of the clinical efficacy according to RECIST V1.1 of CTL-002 in combination with an anti-PD-1 checkpoint inhibitor by assessment of: o The proportion of participants with tumor shrinkage (defined as reduction in sum of diameters of target lesions ≥ -5%), a confirmed PR and/or CR, and ORR. o The interval between the date of first CTL-002 administration and first documented evidence of a PR or CR (TTR). See protocol, Evaluation of the number of participants with AEs, including SAEs, clinical laboratory data, vital signs, ECGs, physical examination (including neurological assessment), and ECOG performance status.

Evaluation of PK parameters of CTL-002 (e.g., Cmax, AUC, and t1/2)., Evaluation of treatment-emergent cytokine and chemokine profiles in peripheral blood., Evaluation of treatment-induced ADA., Evaluation of GDF-15 serum levels and their correlation with pharmacodynamics and clinical response., To assess muscle mass (e.g., L3 skeletal muscle index [L3SMI]).

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Germany, Spain