Malignant Solid Tumours Clinical Trial
Official title:
Phase I Study, Open, Dose Escalation, in Adult Patients With Advanced Solid Tumours, to Evaluate Tolerability, Pharmacokinetics and Pharmacodynamics of PDM08 Administered Twice a Week Cycles of 4 Weeks.
This phase I study in adult patients with advanced solid tumours is designed to evaluate toxicity, drug exposure (pharmacokinetics) and drug action (pharmacodynamics) of a new molecule, PDM08, administered twice a week cycles of 4 weeks. This drug has shown antitumoral activity in several murine cancer models.
Phase I study, open, dose escalation, in adult patients with advanced solid tumours, to
evaluate tolerability, pharmacokinetics and pharmacodynamics of ascending PDM08 doses
administered twice a week cycles of 4 weeks.
After checking the safety of the first drug doses, a new dose escalation was proposed and
approved by the Ethic Committee and the Medicines Agency.
This clinical trial is carried out in adult patients with advanced solid tumours whose
disease has progressed despite standard therapy, or for which there is no standard
antineoplastic therapy, or are refractory to it.
In pharmacodynamic non clinical studies, PDM08 presented antitumour activity against
different tumour models including, renal, colon, lung, prostate and breast cancer models.
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Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04765462 -
Allogeneic γδ T Cell Therapy for the Treatment of Solid Tumors
|
Phase 1/Phase 2 |