drugset
drugset / Trial / NCT05712356

A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors

NCT05712356 ↗

Phase 2 Terminated 66 enrolled Lisata Therapeutics, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in patients with previously untreated cholangiocarcinoma or those that have progressed after first-line treatment for cholangiocarcinoma. The main questions it aims to answer are: * is the new drug plus standard treatment safe and tolerable * is the new drug plus standard treatment more effective than standard treatment

Timeline

Start
2023-05-13
Primary completion
2026-04-05
Completion
2026-04-05

Drugs

EvaluationDrugModalityDoseRoute
Subject certepetide Peptide 3.2 mg/kg Intravenous
Background Cisplatin Other / unclassified 25 mg/m2 Intravenous
Background Durvalumab Monoclonal antibody 1500 mg Intravenous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous
Background Levoleucovorin Unknown 200 mg/m2 Intravenous
Background Levoleucovorin Unknown 400 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications

gallbladder carcinoma intrahepatic cholangiocarcinoma