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

TerminatedPhase 1

Sponsor: Novartis Pharmaceuticals

Conditions: Advanced EGFR Mutant Non Small Cell LungCancer (NSCLC), KRAS G12-mutant NSCLC, Esophageal Squamous Cell Cancer (SCC), Head/Neck SCC, Melanoma

Interventions: TNO155, TNO155 in combination with EGF816 (nazartinib)

Countries: United States, Canada, Italy, Japan, Netherlands, Singapore, South Korea, Spain

The purpose of this first in human (FIH) trial was 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 overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (18)

Tampa, Florida, United States
Boston, Massachusetts, United States
New York, New York, United States
Nashville, Tennessee, United States
Toronto, Ontario, Canada
Milan, MI, Italy
Kobe, Japan
Rotterdam, South Holland, Netherlands
Amsterdam, Netherlands
Singapore, Singapore
Seoul, South Korea
Seoul, South Korea
L'Hospitalet de Llobregat, Barcelona, Spain
Barcelona, Catalonia, Spain
Madrid, Spain
Madrid, Spain
Madrid, Spain
Taipei, Taiwan