Vanderbilt Clinical Trials

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

Purpose

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

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental LSTA1 arm for Untreated Cholangiocarcinoma		Drug: LSTA1 LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given Other names: certepetide CEND-1 Drug: Durvalumab 1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles Other names: Imfinzi 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
Experimental LSTA1 arm for Second-Line Cholangiocarcinoma		Drug: LSTA1 LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given Other names: certepetide CEND-1 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) Other names: Oxaliplatin Folinic acid Fluorouracil
Placebo Comparator Placebo arm for Untreated Cholangiocarcinoma		Drug: Durvalumab 1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles Other names: Imfinzi 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: Placebo Placebo given as a slow IV push over 1 minute when standard treatment(s) are given
Placebo Comparator Placebo arm for Second-Line Cholangiocarcinoma		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) Other names: Oxaliplatin Folinic acid Fluorouracil Drug: Placebo Placebo given as a slow IV push over 1 minute when standard treatment(s) are given

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Lisata Therapeutics, Inc.

Study Contact

Kathryn Shantz
484-437-6500
kshantz@lisata.com

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.