TerminatedPhase 2

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

Stopped: The study was halted prematurely to allow analysis of the results.

United States66 participantsStarted 2023-05-13

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 tran…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial was terminated early — can you find out why it was stopped, and what that might mean for the safety or usefulness of LSTA1 as a treatment option for my type of bile duct or gallbladder cancer?
2Since the trial was in Phase 2 and was measuring how many patients experienced adverse events as its primary outcome, does that mean there's still a lot we don't know about whether LSTA1 is safe or effective, and how should that uncertainty affect my decision-making right now?
3Because this study has been terminated, are there any other active clinical trials testing LSTA1 or similar approaches for cholangiocarcinoma or gallbladder cancer that might be worth looking into instead?
4Given that this trial was comparing LSTA1 added to standard of care versus standard of care alone, would standard of care on its own still be a strong first option for me, and what does that treatment typically look like for my specific diagnosis?
5Is there any published or preliminary data from this trial — even partial results — that you could review to help us understand whether LSTA1 showed any early signals of benefit or harm before the study was stopped?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Subjects Experiencing Any Adverse Event

Timeframe: From time of consent until 30 days after treatment discontinuation, up to 18 months

Trial details

NCT IDNCT05712356

SponsorLisata Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-05

Results submitted2026-04-09

View on ClinicalTrials.gov More Cholangiocarcinoma trials