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Protein Tyrosine Phosphatase Inhibitor

TNO155 +/- Nazartinib for Advanced Cancers

Phase 1
Waitlist Available
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
Must not have
Clinically significant cardiac disease.
Tumors harboring known activating KRAS, NRAS, HRAS, BRAF or PTPN11 (SHP2) mutations. (Exceptions are KRAS G12-mutant NSCLC's)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years; at least once per treatment cycle
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I can perform daily activities with minimal assistance.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a serious heart condition.
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My tumor has specific genetic mutations, but not the KRAS G12 mutation.
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I have ongoing diarrhea or a condition like Crohn's disease.
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I have skin conditions with blistering or peeling.
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I have had a bone marrow or solid organ transplant.
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I have eye problems that could risk further eye injury.
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I am currently taking immunosuppressive drugs or chronic corticosteroids.
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I have or had lung scarring or inflammation not caused by an infection.
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I have or am at risk for blocked veins in my eye.
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My bone marrow is not working well.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2,921 Previous Clinical Trials
4,254,085 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
~7 spots leftby May 2025
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