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RECRUITING
NCT06589401
PHASE1

Oral Paclitaxel for Patients with Advanced Solid Tumors

Sponsor: InnoUp Farma S.L.

View on ClinicalTrials.gov

Summary

Phase I trial evaluating the safety, tolerability, and pharmacokinetic profile of INP12, a nanoparticles-based oral paclitaxel, in patients with advanced solid tumors The aim in Part A (Escalation phase) is to determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (in the absence of exceeding the MTD)and the recommended phase II dose (RP2D) of INP12 administered orally once a week during three consecutive weeks under a 28-day cycle in patients with advanced solid tumors. The aim in Part B (Expansion phase) is to assess the safety and tolerability of INP12 as monotherapy at the RP2D or highest protocol-defined dose in patients with selected advanced solid tumors.

Official title: A Phase I Trial Evaluating the Safety, Tolerability, and Pharmacokinetic Profile of INP12 in Patients with Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2022-09-01

Completion Date

2026-04

Last Updated

2024-09-19

Healthy Volunteers

No

Conditions

Interventions

DRUG

INP12

Oral paclitaxel

Locations (1)

VHIO

Barcelona, Catalonia, Spain