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TU2218 + Checkpoint Inhibitors for Solid Tumors
Study Summary
This trial is testing a new cancer drug, TU2218, to see if it is safe and effective. Part A is testing it by itself and Part B is testing it in combination with another cancer drug.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 22 Patients • NCT03019640Trial Design
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- I do not have any serious infections, including active hepatitis B or C, or HIV/AIDS.I had heart or aortic surgery less than 6 months ago.I haven't taken high-dose aspirin or certain blood thinners in the last 10 days.My tumor is pressing on or invading major blood vessels, or it's at risk of bleeding.I have not had a heart attack or fluid around my heart in the last 6 months.I have waited long enough after my last cancer treatment and any side effects are mild.My liver and kidney functions meet the required levels.I cannot stop taking my chronic steroids or other immune-suppressing drugs.I have a moderate or severe heart valve problem.I finished radiotherapy at least 2 weeks ago with minimal side effects.I am a woman who can have children and have a recent negative pregnancy test.I cannot or will not stop taking certain strong medications at least 8 days before the study starts.I've been on a stable dose of corticosteroids higher than 10mg/day for over 4 weeks.I am not pregnant or at risk of becoming pregnant and agree to use effective birth control or practice abstinence.I haven't had heart attacks, strokes, blood clots in my lungs or legs, or blocked arteries in the last year.I am currently on antibiotics for an infection.My advanced cancer has not responded to standard treatments, including anti-PD-(L)1 therapy.My blood counts and clotting factors are within a healthy range.I do not have uncontrolled cancer spread to my brain, severe fluid buildup, or major liver involvement.I cannot stop my blood thinning medication for the duration of the study and 28 days after.I have an autoimmune disease, but it's not vitiligo, hypothyroidism, or resolved childhood asthma.I am fully active or can carry out light work.I have severe heart failure.My heart tests show high troponin or BNP levels.I have not received a live vaccine in the last 30 days.I can swallow pills.I am not willing to stop taking herbal supplements or traditional medicines.My cancer can be measured by standard criteria.I have or had lung inflammation not caused by an infection.I have been treated before for my condition with drugs targeting TGF-β.I have conditions that affect my ability to swallow or absorb medications.I have a history of aneurysm in my heart or major blood vessels.I have not had major surgery in the last 28 days and do not plan any during the study.I am currently breastfeeding.I am at least 18 years old or meet the legal age for study consent in my area.I am not currently using any non-permitted drugs or substances.I cannot or will not stop taking stomach acid-reducing drugs for 8 days before the study starts.I have previously taken anti-PD(L)1 drugs without severe side effects.My advanced cancer has no effective standard treatment or treatments have failed.
- Group 1: TU2218 Phase 1a
- Group 2: TU2218 Food Effect
- Group 3: TU2218 + Anti-PD-1 antibody Phase 1b
- Group 4: TU2218 Phase 2a
- Group 5: TU2218 + Anti-PD-1 antibody Phase 2b
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many participants are involved in this experiment?
"Affirmative. Clinicaltrials.gov provides evidence that, as of August 22nd 2022, this research trial is still actively recruiting volunteers - 240 in total from a sole medical centre since its inception on December 2nd 2021."
What primary goals is this research attempting to achieve?
"This trial's primary purpose is to determine the Maximum Tolerable Dose (MTD) of TU2218 when administered either alone or in tandem with an anti-PD-1 antibody. Secondary objectives include estimating its terminal half-life, ascertaining the incidence of treatment emergent adverse events, and measuring duration of response over a 24 week period."
Is this trial actively seeking enrollees?
"Clinicaltrials.gov has reported that this clinical trial is currently enrolling participants with the original posting on December 2nd 2021 and most recent update on August 22nd 2022."
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