CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Carotuximab (TRC105) +1 moredrug
Likely dose
Carotuximab (TRC105) 15 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02560779
NCT02560779Phase 2Completed
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An Open Label Phase 1B/2 Trial of TRC105 and Sorafenib in Patients With Hepatocellular Carcinoma (HCC)

Tracon Pharmaceuticals Inc.·interventional·Posted Sep 25, 2015·Updated Jul 17, 2020

In Brief

A Phase 2 clinical trial evaluating Carotuximab (TRC105) and Sorafenib for Hepatocellular Carcinoma. Completed, enrolled 27 participants across 3 sites.

Detailed Summary

The purpose of the phase 1b portion is to evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose sorafenib in patients with hepatocellular carcinoma. Up to 18 patients will be treated. The purpose of the phase 2 portion is to estimate the ORR of patients with hepatocellular carcinoma by RECIST 1.1. Up to 21 patients will be treated in phase 2.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 25, 2015
Enrollment StartNov 1, 2016
Primary CompletionAug 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.8 years ago

Interventions

Carotuximab (TRC105)drug

Bi-weekly iv TRC105 (15 mg/kg) will be given with 400mg sorafenib twice daily in the phase 1B portion of the study. Weekly iv TRC105 (10 mg/kg) will be given with 400mg sorafenib twice daily in the phase 2 portion of the study.

Sorafenibdrug

400 mg of sorafenib will be given twice daily.