All Solid Tumors Clinical Trial
Official title:
A Non-randomized, Open-label, Multi-centric Dose-finding Adaptive Phase I/IIa Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Repeated Intravenous IPP-204106N Administrations in Adult Patients With Advanced Solid Tumors
The experimental plan will consist in:
The dose-finding Bayesian adaptive phase I portion of the study is designed to determine the
optimal and recommended dose of IPP-204106N using a Bayesian "with memory" design with
combined toxicity and pharmacokinetic endpoints to determine doses for successive cohorts of
three patients. The Bayesian methodology allows updating information as the trial progresses
and stopping the trial as soon as the information obtained is deemed to be sufficient.
Preclinical toxicokinetic studies of N6L and IPP-204106N in dogs and the first phase I
clinical trial with N6L will be used to inform the prior distribution in the present study.
The decisional part, according to the results of the phase I portion of the study, will
define the optimal dose recommended for the phase IIa portion of the study.
The phase IIa portion of the study will confirm the optimal dose, and is designed to
evaluate the safety and the preliminary efficacy of IPP-204106N in an expanded patient
population treated at the recommended dose of IPP-204106N.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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