Liver Cancer > NMS-01940153E

NMS-01940153E for Liver Cancer

Recruiting in Palo Alto (17 mi)

+8 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Nerviano Medical Sciences

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a Phase I/II, open-label, non-randomized, multicenter study to explore safety, tolerability and antitumor activity of NMS-01940153E as single agent in adult patients with unresectable hepatocellular carcinoma (HCC) previously treated with systemic therapy. The Phase I portion is designed as a dose-escalation study in sequential cohorts of patients aimed to obtain the maximum tolerated dose (MTD) that is defined based on the dose limiting toxicities (DLTs) observed in the first cycle of treatment. The Phase II portion is designed as a two-stage study with an interim analysis for futility and stopping criteria for unacceptable toxicity to assess the antitumor activity of NMS-01940153E in adult patients with unresectable HCC previously treated with systemic therapy measured as objective response rate.

Eligibility Criteria

Adults with advanced liver cancer (HCC) that can't be surgically removed and who have already tried systemic therapy. They should not have had more than three prior treatments, must be in relatively good health (Child-Pugh score ≤ 6, ECOG status of 0 or 1), and willing to use effective contraception.

Participant Groups

The trial is testing NMS-01940153E's safety and effectiveness for liver cancer patients who've had previous treatments. It starts by finding the highest dose patients can take without serious side effects, then checks how well it works at shrinking tumors.

Group I: NMS-01940153E Experimental Treatment 1 Intervention

Phase I: Patients will be allocated to sequential cohorts of progressively higher dose levels of NMS-01940153E based on the presence of Dose Limiting Toxicities (DLT). Phase II: Patients will be treated at the recommended Phase II dose (RP2D) defined in the Phase I portion.

Find A Clinic Near You

Research locations nearby Select from list below to view details:

Siteman Cancer Center - Washington University Medical Campus Saint Louis, MO

University of California Irvine Health Orange, CA

Who is running the clinical trial?

Nerviano Medical Sciences Lead Sponsor

References