Clinical trial details

A Phase I/Ib, Open-label, Multicentre, Multiple Ascending Doses Study Evaluating the Safety/Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral ITF3756 as Monotherapy and in Combination with an Anti-Cytotoxic T-Lymphocyte-Associated Protein 4 Agent in Patients with Advanced Solid Tumors

Identifier

ITF/3756/01

Sponsor

ITALFARMACO SPA

Principal Investigator

IRENE BRAÑA GARCIA

Service

Oncology

Study details

Tumor type: ALL SOLID TUMORS
Stage: Advanced
Main Investigational Agent : Epigenetics
Phase: I
Randomization: Non-randomized

Molecular details

Biomarker: Not applicable
Biomarker criteria: Not applicable
Prescreening: Not applicable
Additional study population requirements: Inclusion criteria: Must be willing to undergo tumor biopsies (Part 1B and Part 2B [dose expansion cohorts] only). For Part 1A and 2A, tumor biopsies will be voluntary.

Drug details

Arm A: ITF3756
Arm B: ITF3756 AND Ipilimumab

Links

Clinical Trials GOV (NCT identifier): NL
EU Clinical Trials Register (eudraCT Identifier): Not applicable