Study on Adding LSTA1 to Standard Treatment Versus Standard Treatment Alone for Advanced Solid Tumors

Sponsor: Lisata Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05712356

Provider View

This clinical trial is testing whether adding a new drug, LSTA1, to the usual treatment is safe and more effective than the usual treatment alone for patients with advanced solid tumors, specifically cholangiocarcinoma.

Patient Parameters

Program Overview

The purpose of this study is to find out if a new drug, LSTA1, when combined with the standard treatment, is safe and works better than the standard treatment alone for patients with advanced solid tumors, particularly those with cholangiocarcinoma. The study will include patients who have not been treated before or whose cancer has worsened after initial treatment.

Description

This is a Phase 2a study where neither the participants nor the researchers know who is receiving the new drug or a placebo. It involves multiple centers and is randomized, meaning participants are randomly assigned to receive either the standard treatment with LSTA1 or the standard treatment with a placebo. The study includes patients with advanced solid tumors, focusing on those with cholangiocarcinoma who have not been treated before or whose cancer has progressed after initial treatment.

The study has several stages: a screening period to check eligibility, a short run-in period to start the treatment, a treatment period, a follow-up visit after treatment ends, and a long-term follow-up period.

Participants will be screened for eligibility within 28 days before starting the treatment. Once eligible, they will be randomly assigned to one of two groups: one receiving the standard treatment with LSTA1 and the other receiving the standard treatment with a placebo. During the initial 3-day run-in period, participants will receive only LSTA1 or the placebo. After this, the first cycle of treatment will begin. Tumor scans will be done every 8 weeks to monitor progress.

Eligibility Criteria

Inclusion Criteria

  • Good overall health with an ECOG performance status of 0 or 1.
  • Expected to live at least 3 more months.
  • Have at least one tumor that can be measured.
  • Good organ and bone marrow function.
  • Use effective birth control.
  • Have either:
    • Metastatic or inoperable cholangiocarcinoma or gallbladder cancer with no prior chemotherapy or targeted therapy, or have had a recurrence more than 6 months after completing chemotherapy.
    • Metastatic or inoperable cholangiocarcinoma or gallbladder cancer that has worsened after first-line chemotherapy and immunotherapy.

Exclusion Criteria

  • Any condition that might interfere with the study or affect safety, including:
    • Major surgery or radiation less than 4 weeks before starting the study.
    • Active infection needing treatment.
    • Active hepatitis B, hepatitis C, or HIV infection.
    • Active tuberculosis.
    • History of organ transplant.
    • Another cancer needing treatment in the last 3 years, except for certain skin or localized cancers.
    • Pregnant or breastfeeding.
    • Serious heart or blood vessel problems in the last 6 months.
  • History of cancer spread to the brain causing symptoms.
  • For first-line cholangiocarcinoma, active autoimmune disease that could worsen with immune-stimulatory treatment, except for certain stable conditions like Type 1 diabetes or thyroid disorders.

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