New cancer pill shows early promise, but trial halted

NCT ID NCT03114319

Terminated Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This early-stage trial tested an oral drug called TNO155, alone or with another drug (nazartinib), in 227 adults with advanced solid tumors like lung cancer, melanoma, and head/neck cancer. The main goal was to check safety and find the right dose. The study was terminated early, so results are limited and no clear benefit has been shown yet.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: TNO155 (a SHP2 inhibitor) taken orally, alone or with nazartinib
What this could lead to: If successful, this could point toward a new treatment option for certain advanced cancers like lung or skin cancer.
What could go wrong: This was a very early (Phase 1) trial that was terminated, so it's unclear if the drug is safe or effective. Many early cancer drugs fail to show benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma esophageal squamous cell carcinoma gastrointestinal stromal tumor head and neck squamous cell carcinoma melanoma neoplasm non-small cell lung carcinoma Noonan syndrome Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ADVANCED EGFR MUTANT NON SMALL CELL LUNGCANCER (NSCLC) ADVANCED GASTROINTESTINAL STROMAL TUMORS (GIST) ADVANCED NRAS/BRAFT WT CUTANEOUS MELANOMA ESOPHAGEAL SQUAMOUS CELL CANCER (SCC) HEAD/NECK SCC KRAS G12-MUTANT NSCLC MELANOMA

Contacts and locations

Locations

Dana Farber Cancer Center

Boston, Massachusetts, 02215, United States
H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States
Memorial Sloane Ketterin Cancer Ctr

New York, New York, 10065, United States
Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada
Novartis Investigative Site

Milan, MI, 20141, Italy
Novartis Investigative Site

Kobe, 650-0017, Japan
Novartis Investigative Site

Rotterdam, South Holland, 3015 GD, Netherlands
Novartis Investigative Site

Amsterdam, 1066 CX, Netherlands
Novartis Investigative Site

Singapore, 168583, Singapore
Novartis Investigative Site

Seoul, 03080, South Korea
Novartis Investigative Site

Seoul, 05505, South Korea
Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain
Novartis Investigative Site

Madrid, 28009, Spain
Novartis Investigative Site

Madrid, 28034, Spain
Novartis Investigative Site

Madrid, 28040, Spain
Novartis Investigative Site

Taipei, 10002, Taiwan
Sarah Cannon Research Institute

Nashville, Tennessee, 37221, United States

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