Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors
Megadott ok: Business reasons and not due to any safety concerns
Key facts
- Where
- Boston, Nashville, New York és Tampa, Egyesült ÁllamokSee the 4 sites
- Phase
- 1. fázis
Where in Egyesült Államok
- Dana Farber Cancer CenterBoston, Egyesült ÁllamokNo longer taking part
- Sarah Cannon Research InstituteNashville, Egyesült ÁllamokNo longer taking part
- Memorial Sloane Ketterin Cancer CtrNew York, Egyesült ÁllamokNo longer taking part
- H Lee Moffitt Cancer Center and Research InstituteTampa, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT03114319EU 2023-508925-29-00
- Record updated
- 2026. július 9.
- Original description
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.Read full original descriptionShow less
An Open-label, Multi-center, Phase I, Dose Finding Study of Oral TNO155 in Adult Patients With Advanced Solid Tumors
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.
Inclusion: Able to understand and voluntarily sign the ICF and able to comply with the study visit schedule and the other protocol requirements; Patient (male or female) ≥18 years of age willing to agree to not father a child/become pregnant and comply with effective contraception criteria; 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; ECOG (Eastern cooperative oncology group) performance status ≤2; Additional criteria only appying to TNO155 in combination with EGF816 (nazartinib):; Patients must be screened for Hepatitis B virus and Hepatitis C virus.
Exclusion: Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use at the time of study entry; Patients who have undergone a bone marrow or solid organ transplant; 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; Clinically significant cardiac disease; Active diarrhea or inflammatory bowel disease; Patients with a known history of human immunodeficiency virus (HIV) seropositivity; Patients with a history or presence of interstitial lung disease or interstitial pneumonitis; Bullous and exfoliative skin disorders at screening of any grade; Tumors harboring known activating KRAS, NRAS, HRAS, BRAF or PTPN11 (SHP2) mutations. (Exceptions are KRAS G12-mutant NSCLC's); History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO; Insufficient bone marrow function; Insufficient hepatic and renal function; Additional criteria only appying to TNO155 in combination with EGF816 (nazartinib):; Presence of clinically significant ophthalmological abnormalities that might increase the risk of corneal epithelial injury.