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

NCT ID: NCT05712356

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-24
• Study Completion Date: 2030-03-31

Brief 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

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

LSTA1 arm for Untreated Cholangiocarcinoma

Group Type: EXPERIMENTAL

certepetide

Intervention Type: DRUG

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

Durvalumab

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

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

Gemcitabine

Intervention Type: DRUG

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

LSTA1 arm for Second-Line Cholangiocarcinoma

Group Type: EXPERIMENTAL

certepetide

Intervention Type: DRUG

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

FOLFOX regimen

Intervention Type: DRUG

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)

Placebo arm for Untreated Cholangiocarcinoma

Group Type: PLACEBO_COMPARATOR

Durvalumab

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

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

Gemcitabine

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Placebo arm for Second-Line Cholangiocarcinoma

Group Type: PLACEBO_COMPARATOR

FOLFOX regimen

Intervention Type: DRUG

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)

Placebo

Intervention Type: DRUG

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

Interventions

certepetide

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

Intervention Type: DRUG

Durvalumab

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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)

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

CEND-1; LSTA1; Imfinzi; Oxaliplatin; Folinic acid; Fluorouracil

Eligibility Criteria

Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Life expectancy ≥ 3 months
• At least one measurable lesion as assessed by RECIST 1.1
• Adequate organ and marrow function
• Adequate contraception
• Patients with either of the following:

• Pathologically confirmed metastatic or unresectable cholangiocarcinoma or gallbladder carcinoma (GBC), with no prior systemic chemotherapy or targeted therapy or loco-regional therapy (including but not limited to transarterial chemoembolization, transarterial embolization, transarterial chemotherapy or transarterial radioembolization). Patients with recurrent disease more than 6 months after completion of adjuvant chemotherapy following curative resection are eligible.
• Pathologically confirmed metastatic or unresectable cholangiocarcinoma or GBC with progression of disease after first-line chemotherapy and immunotherapy.

Exclusion Criteria

• Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to:

• Any major surgery or irradiation less than 4 weeks prior to baseline disease assessment
• Active infection (viral, fungal, or bacterial) requiring systemic therapy
• Known active hepatitis B virus, hepatitis C virus, or HIV infection
• Active tuberculosis as defined per local guidance
• History of allogeneic tissue/solid organ transplant
• Prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
• Pregnant or breastfeeding
• Clinically significant or symptomatic cardiovascular/cerebrovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before randomization
• History or clinical evidence of symptomatic central nervous system (CNS) metastases

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lisata Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristen K Buck, MD

Role: STUDY_CHAIR

Lisata Therapeutics, Inc.

Locations

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Mayo Clinic Arizona

Phoenix, Arizona, United States

University of Arizona Cancer Center

Tucson, Arizona, United States

Moffitt Cancer Center

Tampa, Florida, United States

Alliance for Multispecialty Research

Merriam, Kansas, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

University of Kentucky Medical Center

Lexington, Kentucky, United States

Norton Cancer Institute, Downtown

Louisville, Kentucky, United States

Norton Cancer Institute, Audubon

Louisville, Kentucky, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Northwell Health - Zuckerberg Cancer Center

Lake Success, New York, United States

Stony Brook Cancer Center

Stony Brook, New York, United States

FirstHealth of the Carolinas, Inc.

Pinehurst, North Carolina, United States

Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center

Cincinnati, Ohio, United States

Spartanburg Medical Center

Spartanburg, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Countries

United States

Other Identifiers

2023-503740-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LSTA1-P02

Identifier Type: -

Identifier Source: org_study_id