Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Carcinoma

Cholangiocarcinoma

Urinary Bladder Neoplasms

Disease Progression

Gallbladder Neoplasms

Bile Duct Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Gallbladder Diseases

Bile Duct Diseases

Bile Duct Cancer

Gallbladder Cancer

Intrahepatic Cholangiocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Gemcitabine

Oxaliplatin

Leucovorin

Fluorouracil

Levoleucovorin

Cisplatin

Immunomodulating Agents

Durvalumab

Folic Acid

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Immunological

Folinic Acid

Folate

Vitamin B9

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

LSTA1

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

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

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

The following will be given every 14 days:

* oxaliplatin 85 mg/m² and l-folinic acid 175 mg or d,l-folinic acid 350 mg 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)

FOLFOX regimen

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

Placebo

Kathryn Shantz

Madappa Kundranda, MD, PhD

Clinical Trials Referral Office

Bassam Sonbol, MD

Prisca Zimmerman

Rachna Shroff, MD

Linda Gozar

David Park, MD

Taylor Atkinson

Richard Kim, MD

Shannon Bradbury

Anup Kasi, MD, MPH

Sarah Howard

Susanne Arnold, MD

Michael Driscoll, MD

Nguyen Tran, MD

Jenna Battaglia

Anna Levy, DO

Sumbul Yousafi

Roger Keresztes, MD

Demetria Jacks, MD

Lindsey Ferry

Charles Kuzma, MD

Abby Reed, RN

Alexander Starodub, MD, PhD

Kristen Ford

Vikas Dembla, MD

VUMC Patient Recruitment Office

Thatcher Heumann, MD

Ellen Siglinsky

David Hsieh, MD

Ian Hu, MD, PhD

Stephanie Van Bebber

Raymond Wadlow, MD

Kristen K Buck, MD

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

This is a Phase 2a, double-blind, placebo-controlled, multi-center, randomized study of LSTA1 when added to standard of care (SoC) versus SoC alone in patients with advanced solid tumors. The study will include patients with previously untreated cholangiocarcinoma or those that have progressed after first-line treatment for cholangiocarcinoma.

The study will consist of a screening period, a run-in period, a treatment period, an end-of-treatment follow-up visit, and a long-term follow up period.

Participants who provide informed consent will be screened for eligibility within 28 days prior to beginning the study treatment run-in period. Once eligibility is confirmed, participants will be randomized to one of the two treatment groups (SoC + placebo vs. SoC + LSTA1).

During the 3-day run-in period, participants will only receive the LSTA1 or placebo components of their randomized treatment regimen. After the 3-day run-in, Cycle 1 of treatment will commence. Tumor scans will be performed every 8 weeks (56 days ± 7 days) while on treatment.

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

A Phase 2a, Double-blind, Placebo-controlled, Multi-center, Randomized Study Evaluating LSTA1 When Added to Standard of Care (SoC) Versus Standard of Care Alone in Subjects With Advanced Solid Tumors (BOLSTER)

The National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE) will be used to grade the intensity of adverse events throughout the study

Lisata Therapeutics, Inc.

Spots Global Cancer Trial Database for lsta1

Every month we try and update this database with for lsta1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lsta1

Every month we try and update this database with for lsta1 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lsta1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.