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Protein Tyrosine Phosphatase Inhibitor

TNO155 +/- Nazartinib for Advanced Cancers

Phase 1
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG (Eastern cooperative oncology group) performance status ≤2
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years; at least once per treatment cycle
Awards & highlights

Study Summary

This trial is to test how safe and tolerable a new cancer drug is, and to find the best dose of it to give to patients in the future.

Who is the study for?
Adults over 18 with advanced solid tumors like melanoma or lung cancer, who've tried standard treatments without success or can't tolerate them. They must understand the study and follow its schedule, agree to effective contraception, and have an acceptable level of physical function (ECOG ≤2). People with certain viral infections, specific genetic mutations in their tumors, significant health issues including heart disease, eye conditions that increase injury risk, active severe skin disorders or bowel inflammation are excluded.Check my eligibility
What is being tested?
The trial is testing TNO155 alone and combined with EGF816 (nazartinib) to find safe doses for future studies. It's a first-in-human study focusing on safety and tolerability in patients with selected types of advanced solid tumors. The goal is also to determine the recommended dose levels for subsequent research phases.See study design
What are the potential side effects?
While not explicitly listed in the provided information, typical side effects for drugs like TNO155 could include fatigue, nausea, diarrhea; however this being a first-in-human trial means part of its purpose is to identify potential side effects from these new treatment combinations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can perform daily activities with minimal assistance.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years; at least once per treatment cycle
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years; at least once per treatment cycle for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events
Number of participants with dose limiting toxicities
Secondary outcome measures
Area under the curve
Cmax
Overall response rate
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: TNO155 in combination with EGF816 (nazartinib)Experimental Treatment1 Intervention
TNO155 in combination with EGF816 (nazartinib) in patients with advanced EGFR mutant NSCLC
Group II: TNO155Experimental Treatment1 Intervention
TNO155 for oral administration

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,859 Previous Clinical Trials
4,198,103 Total Patients Enrolled

Media Library

TNO155 (Protein Tyrosine Phosphatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03114319 — Phase 1
Non-Small Cell Lung Cancer, Esophageal Cancer, Head/Neck Cancer, Melanoma Research Study Groups: TNO155, TNO155 in combination with EGF816 (nazartinib)
Non-Small Cell Lung Cancer, Esophageal Cancer, Head/Neck Cancer, Melanoma Clinical Trial 2023: TNO155 Highlights & Side Effects. Trial Name: NCT03114319 — Phase 1
TNO155 (Protein Tyrosine Phosphatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03114319 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals being sought to participate in this experiment?

"This study is accommodating individuals aged 18 and up, but not exceeding 99 years."

Answered by AI

Has TNO155 been subject to any other research initiatives?

"Presently, 6 trials actively studying TNO155 are in process with none of these studies reaching Phase 3. Most research for TNO155 is based out of Madrid, Alberta; however there are 55 sites conducting investigations concerning this medication."

Answered by AI

Is this the inaugural occurrence of a study like this?

"Since 2014, TNO155 has been the focus of clinical research. Novartis Pharmaceuticals initially sponsored a study involving 225 participants in that year and following positive results it was approved for use in Phase 1 & 2 trials. Currently there are 6 active studies concerning TNO155 spread across 18 cities and 13 countries."

Answered by AI

Does this research still have open enrollment?

"According to the clinicaltrials.gov website, this research study is actively looking for participants and has been since May 26th 2017 with its most recent update occurring in October 17th 2022."

Answered by AI

What are the stipulations for joining this medical trial?

"This clinical trial requires 255 adult volunteers aged between 18 and 99. Eligibility criteria include the ability to understand and sign an informed consent form, comply with study protocols and follow a visit schedule; men or women who agree not to conceive during the course of the trial; having progressed following standard therapy or for whom no suitable treatment exists; Eastern cooperative oncology group performance status 2 or lower; as well as screening tests for Hepatitis b virus and Hepatitis c virus infections."

Answered by AI

Is TNO155 a reliable and secure treatment option for individuals?

"Due to the lack of prior clinical data, TNO155 was assessed as a safety risk level 1. This early-phase trial is primarily focused on establishing efficacy and effective safety metrics."

Answered by AI

What is the participant count of this clinical experiment?

"Affirmative. Clinicaltrials.gov's data affirms that this trial is actively recruiting patients, which it has been since May 26th 2017, and the last edit was on October 17th 2022. To reach their milestone of 255 participants they are looking for volunteers in 2 different sites."

Answered by AI

What are the expected outcomes of this clinical experiment?

"This 28-day trial will primarily focus on tracking the number of participants with adverse effects. Secondary objectives include measuring area under the curve, pERK levels in newly obtained tumor samples by IHC, and Cmax levels when TNO155 and EGF816 (nazartinib) are administered together."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors
2017. "Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03114319.
~32 spots leftby May 2025
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