Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors
- 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
- Tumors harboring known activating KRAS, NRAS, HRAS, BRAF or PTPN11 (SHP2) mutations. (Exceptions are KRAS G12C CRC and KRAS G12C NSCLC)
- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
- 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
- Insufficient bone marrow function
- Insufficient hepatic and renal function.
This study has been designed as a Phase I, open-label, dose finding study with a dose escalation part and a dose expansion part in adult patients with selected advanced solid tumors. The study treatment, TNO155, will be taken until the patient experiences unacceptable toxicity, progressive disease and/or treatment is discontinued at the discretion of the investigator or the patient or due to withdrawal of consent. Some patients will be participating in a food effect investigation as an exploratory objective.
Trial Phase Phase I
Trial Type Treatment
Novartis Pharmaceuticals Corporation
- Primary ID CTNO155X2101
- Secondary IDs NCI-2017-01726, 2016-001861-10
- Clinicaltrials.gov ID NCT03114319