At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed advanced solid tumor with measurable or evaluable disease
- ✓Metastatic cutaneous melanoma with measurable disease and progression on ≤2 prior lines including ≥1 PD-1/PD-L1 regimen
- ✓Relapsed/refractory lymphoma not amenable to standard care
- ✓Solid tumor single-agent Phase II: ≤3 prior lines for metastatic disease
- ✕Allergic reaction to any component of NUC-7738
- ✕CNS or leptomeningeal metastases (unless treated/stable with specific criteria)
- ✕Prior chemotherapy, radiotherapy, immunotherapy, or investigational agent within 28 days
- ✕Nitrosoureas or mitomycin C within 6 weeks
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II, Open-label, Dose-escalation and Expansion Study to Assess the Safety, Pharmacokinetics and Clinical Activity of NUC-7738, a Nucleotide Analogue, in Patients With Advanced Solid Tumours and Lymphoma
In Brief
A Phase 2 clinical trial evaluating NUC-7738 and Pembrolizumab for Advanced Cancer and 3 related conditions. Currently recruiting, targeting 135 participants across 9 sites.
Signals
Detailed Summary
This 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.
Study Details
Timeline
Interventions
NUC-7738
Pembrolizumab