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

NCT05712356 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-06-06

No results posted yet for this study

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

Conditions

  • Cholangiocarcinoma
  • Gallbladder Cancer
  • Gallbladder Carcinoma
  • Intrahepatic Cholangiocarcinoma
  • Extrahepatic Cholangiocarcinoma
  • Bile Duct Cancer
  • Gall Bladder Cancer
  • Gall Bladder Carcinoma

Interventions

DRUG

certepetide

LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given

DRUG

Durvalumab

1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles

DRUG

Cisplatin

cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles

DRUG

Gemcitabine

gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles

DRUG

FOLFOX regimen

The following will be given every 14 days: * oxaliplatin 85 mg/m² and l-folinic acid 200 mg/m² or d,l-folinic acid 400 mg/m² concurrently, as a 2-hour IV infusion * fluorouracil (5-FU) 400 mg/m² will be given as an IV bolus over 5 minutes * fluorouracil (5-FU) 2400 mg/m² will be administered over 46 hours (via home-infusion pump)

DRUG

Placebo

Placebo given as a slow IV push over 1 minute when standard treatment(s) are given

Sponsors & Collaborators

  • Lisata Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Kristen K Buck, MD · Lisata Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-24
Primary Completion
2026-04-18
Completion
2030-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT05712356 on ClinicalTrials.gov