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FGF401 in HCC and Solid Tumors Characterized by Positive FGFR4 and KLB Expression

NCT02325739 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2024-10-21

Study results available
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Summary

Estimate the maximum tolerated dose and/or recommended phase II dose and efficacy of FGF401 as single agent and in combination with PDR001 in patients with hepatocellular carcinoma and as single agent in patients with other solid malignancies based on RECIST 1.1.

Conditions

  • Hepatocellular Carcinoma (HCC)
  • Solid Malignancies

Interventions

DRUG

FGF401

FGF401 is a FGFR4 inhibitor.

BIOLOGICAL

PDR001

PDR001 is a humanized anti-PD1 IgG4 antibody that blocks the binding of PD-L1 and PD-L2

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-29
Primary Completion
2019-05-30
Completion
2019-05-30
FDA Drug
Yes

Countries

  • United States
  • China
  • France
  • Germany
  • Hong Kong
  • Italy
  • Japan
  • Singapore
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02325739 on ClinicalTrials.gov