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NMS-01940153E for Liver Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Nerviano Medical Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within two years
Awards & highlights
Study Summary
This trial will study safety, tolerability and anti-tumor activity of a drug in people with advanced liver cancer who have already had treatment.
Who is the study for?
Adults with advanced liver cancer (HCC) that can't be surgically removed and who have already tried systemic therapy. They should not have had more than three prior treatments, must be in relatively good health (Child-Pugh score ≤ 6, ECOG status of 0 or 1), and willing to use effective contraception.Check my eligibility
What is being tested?
The trial is testing NMS-01940153E's safety and effectiveness for liver cancer patients who've had previous treatments. It starts by finding the highest dose patients can take without serious side effects, then checks how well it works at shrinking tumors.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical ones may include reactions at the infusion site, fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding tendencies, and potential harm to organs like the liver.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within two years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Drug related dose limiting toxicities (DLT) (Phase I)
Objective Response Rate (ORR) (Phase II)
Secondary outcome measures
Duration of response (DoR) as measured by investigator-assessed RECIST 1.1. and investigator-assessed mRECIST
Objective Tumor Response (Partial and Complete Response) as measured by investigator assessed RECIST 1.1 (Phase I)
Objective response rate as measured by investigator-assessed mRECIST (Phase II)
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: NMS-01940153EExperimental Treatment1 Intervention
Phase I: Patients will be allocated to sequential cohorts of progressively higher dose levels of NMS-01940153E based on the presence of Dose Limiting Toxicities (DLT).
Phase II: Patients will be treated at the recommended Phase II dose (RP2D) defined in the Phase I portion.
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Who is running the clinical trial?
Nerviano Medical SciencesLead Sponsor
12 Previous Clinical Trials
909 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have moderate to severe fluid buildup in my abdomen.My high blood pressure is not under control.My diabetes is not well-managed.I have not had major surgery in the last 4 weeks.I have cancer that has spread to my brain or its coverings.My liver cancer is a specific type called fibrolamellar or mixed hepato-cholangiocarcinoma.My liver cancer diagnosis follows specific guidelines and I can't have standard treatments.I have an infection that hasn't been treated.My condition cannot be cured and does not respond to local treatments.I have not taken strong FMO1/FMO3 inducers in the last week.My side effects from previous treatments are mild or gone.My liver is functioning well.I am currently being treated for another type of cancer.My heart's electrical cycle is longer than normal or I'm at risk for a specific heart rhythm problem.I am starting treatment with direct-acting antivirals.I am on antiviral treatment for my hepatitis B or HIV.My breathing or metabolic condition is not controlled by medication.I have not recently had cancer treatment or radiation.I do not have any health issues that could affect my participation in the study.I am taking medication that is sensitive to changes in my body's enzyme levels.I have a tumor that can be measured by a scan.I have varices at risk of bleeding that haven't been fully treated.I have symptoms of brain function problems due to liver disease.I am 18 years old or older.I am taking medication to prevent blood clots.I have had heart problems or events recently.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: NMS-01940153E
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any new participants being accepted for the trial?
"Affirmative, clinicaltrials.gov has data confirming that this research study is actively enrolling patients. It was initially advertised on November 13th 2020 and the listing was most recently updated on June 21st 2023. The trial seeks to recruit 57 participants from 9 different sites."
Answered by AI
How many healthcare settings are currently executing this trial?
"Participants are being recruited from Siteman Cancer Center - Washington University Medical Campus in Saint Louis, Azienda Sanitaria Locale Napoli 1 Centro - Ospedale del Mare in Naples, Istituto Oncologico Veneto - IRCCS in Padova and 6 other sites."
Answered by AI
How many individuals are being studied in this medical research?
"Affirmative. According to clinicaltrials.gov, this research project is actively searching for participants after being initially posted on November 13th 2020 and updated as recently as June 21st 2023. In total, 57 individuals need to be enrolled from 9 different medical sites."
Answered by AI
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