For Healthcare Professionals

Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Able to understand and voluntarily sign the ICF and able to comply with the study visit schedule and the other protocol requirements.
  2. Patient (male or female) ≥18 years of age willing to agree to not father a child/become pregnant and comply with effective contraception criteria.
  3. 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.
  4. ECOG (Eastern cooperative oncology group) performance status ≤2 Additional criteria only appying to TNO155 in combination with EGF816 (nazartinib):
  5. Patients must be screened for Hepatitis B virus and Hepatitis C virus

EXCLUSION CRITERIA

  1. Tumors harboring known activating KRAS, NRAS, HRAS, BRAF or PTPN11 (SHP2) mutations. (Exceptions are KRAS G12-mutant NSCLC's)
  2. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
  3. 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.
  4. Clinically significant cardiac disease.
  5. Active diarrhea or inflammatory bowel disease
  6. Insufficient bone marrow function
  7. Insufficient hepatic and renal function. Additional criteria only appying to TNO155 in combination with EGF816 (nazartinib):
  8. Patients with a known history of human immunodeficiency virus (HIV) seropositivity.
  9. Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use at the time of study entry.
  10. Patients who have undergone a bone marrow or solid organ transplant
  11. Patients with a history or presence of interstitial lung disease or interstitial pneumonitis
  12. Bullous and exfoliative skin disorders at screening of any grade
  13. Presence of clinically significant ophthalmological abnormalities that might increase the risk of corneal epithelial injury
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-888-669-6682Email iconEmail Study Center

Study’s details


Contition

Advanced EGFR Mutant Non Small Cell Lung Cancer, Esophageal Squamous Cell Cancer, Head-and-Neck Squamous Cell Cancer, RAS/RAF Wild-type Other Solid Tumors,Advanced EGFR-mutant Non-smallcell Lung Cancer,Advanced EGFRmutant NonSmallSellLungCancer (NSCLC),KRAS G12-mutant NSCLC,Esophageal SquamousCellCancer (SCC),Head/Neck SCC,Melanoma,Advanced EGFRmutant NonSmallSellLungCancer (NSCLC),KRAS G12C NSCLC,CRC,Esophageal SquamousCellCancer (SCC),Head/Neck SCC,RAS/RAF Wild-type Other Solid Tumor,HNSCC,Head-and-Neck Squamous Cell Cancer,Head-and-Neck Squamous Cell Cancer, RAS/RAF Wild-type Other Solid Tumors,Other RAS/BRAF Wild-type Solid Tumors,Patients With Advanced EGFR-mutant NSCLC,Patients With Advanced EGFR-mutant Non-smallcell Lung Cancer,RAS/RAF Wild-type Other Solid Tumors

Age

18+

Phase

Phase 1

Participants needed

255

Est. Completion Date

Apr 2024

Treatment type

Interventional


Sponsor

Novartis

ClinicalTrials.gov identifier

NCT03114319

Study number

CTNO155X2101

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