TNO155 +/- Nazartinib for Advanced Cancers

Recruiting in Palo Alto (17 mi)

+20 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this first in human (FIH) trial is 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.

Eligibility Criteria

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.

Inclusion Criteria

I can perform daily activities with minimal assistance.

Exclusion Criteria

I have a serious heart condition.

My tumor has specific genetic mutations, but not the KRAS G12 mutation.

I have ongoing diarrhea or a condition like Crohn's disease.

I have skin conditions with blistering or peeling.

I have had a bone marrow or solid organ transplant.

I have eye problems that could risk further eye injury.

I am currently taking immunosuppressive drugs or chronic corticosteroids.

I have or had lung scarring or inflammation not caused by an infection.

I have or am at risk for blocked veins in my eye.

My bone marrow is not working well.

Participant Groups

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.

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