NUC-7738

A Safety, Pharmacokinetic and Clinical Activity Study of NUC-7738 in Patients With Advanced Solid Tumours and Lymphoma

Ensayo de NuCana plc en Cancer avanzado · Linfoma · Tumor solido · Melanoma.

Más ensayos de: Cáncer avanzado · Linfoma · Tumor sólido · Melanoma.

Fase: Fase 1/2
Estado: Reclutando pacientes
Participantes: 135
Centros: 9
Fin del objetivo primario: ago 2026

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en jun 2019.

Qué mide

Number of patients with dose-limiting toxicities (From the date of consent until 30 days after the last dose of NUC-7738 administered) (del registro, en inglés)

Qué se prueba

Estudio de escalada y expansion de dosis de NUC-7738 administrado por infusion intravenosa como monoterapia y en combinacion con pembrolizumab en pacientes con tumores solidos avanzados.

Lo que dice el documentodose-escalation and expansion study of NUC-7738 administered by intravenous infusion as a monotherapy and in combination with pembrolizumab.

Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a Phase I/II, dose-escalation and expansion study of NUC-7738 administered by intravenous infusion as a monotherapy and in combination with pembrolizumab. In Phase I, NUC-7738 monotherapy is evaluated across two administration schedules (weekly or fortnightly) in a dose-escalation design in patients with advanced solid tumours. The main objectives are to assess the safety and tolerability of NUC-7738, in addition to establishing the Maximum Tolerated Dose (MTD) and dose administration schedule of NUC-7738 for further exploration in the Phase II part of the study. In Phase II, the selected dose and designated dosing schedule will be further evaluated in dose-confirmation expansion cohorts enrolling a total of approximately 40 additional patients with advanced solid tumours. Based on emerging data, approximately 6 patients with cutaneous melanoma will be enrolled to these expansion cohorts and will receive NUC-7738 monotherapy. A further cohort will assess NUC-7738 in combination with pembrolizumab in approximately 6-12 patients with cutaneous melanoma. Based on efficacy signals observed in the initial melanoma combination cohort, a further expansion cohort will be initiated to expand to a total of 40 patients to allow a powered analysis. In addition, 12 patients with lymphoma (with potential expansion to a total of 25 patients) may be enrolled to receive NUC-7738 monotherapy.

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Todos los de NCNA, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03829254), actualizada en ene 2026.