Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors (NCT03114319) | Clinical Trial Compass
TerminatedPhase 1
Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors
Stopped: Business reasons and not due to any safety concerns
United States, Canada, Italy227 participantsStarted 2017-05-26
Plain-language summary
The purpose of this first in human (FIH) trial was to characterize the safety and tolerability of the SHP2 inhibitor TNO155 alone and in combination with EGF816 (nazartinib) and identify a recommended dose for future studies in adult patients with advanced solid tumors in selected indications.
Who can participate
Age range
18 Years – 99 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
. Able to understand and voluntarily sign the ICF and able to comply with the study visit schedule and the other protocol requirements.
. Patient (male or female) ≥18 years of age willing to agree to not father a child/become pregnant and comply with effective contraception criteria.
. Must have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy exists, is tolerated or is appropriate.
. ECOG (Eastern cooperative oncology group) performance status ≤2
. Patients must be screened for Hepatitis B virus and Hepatitis C virus
Exclusion criteria
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
1
Number of participants with adverse events and serious adverse events
Timeframe: up to 5 years; at least once per treatment cycle
2
Number of participants with dose limiting toxicities
Timeframe: up to 28-day cycle
3
Number of participants with dose interruptions and reductions
. Tumors harboring known activating KRAS, NRAS, HRAS, BRAF or PTPN11 (SHP2) mutations. (Exceptions are KRAS G12-mutant NSCLC's)
. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
. Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
. Clinically significant cardiac disease.
. Active diarrhea or inflammatory bowel disease
. Insufficient bone marrow function
. Insufficient hepatic and renal function.
. Patients with a known history of human immunodeficiency virus (HIV) seropositivity.