Clinical Trial 22009

• Overview

  Study Title:

  CTNO155X2101: An Open-Label, Multi-Center, Phase I, Dose Finding Study of Oral TNO155 in Adult Patients with Advanced Solid Tumors

  Summary:

  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.

  Objective:

  Primary Objective- To characterize safety and tolerability of TNO155 as a single agent and in combination with nazartinib, and identify recommended regimens for future studies in adult patients with advanced solid tumors. Secondary Objective- To evaluate the preliminary anti-tumor activity of TNO155 as a single agent and in combination with nazartinib To evaluate the pharmacokinetic (PK) profile of TNO155 as a single agent and of TNO155 and nazartinib when administered in combination To assess pharmacodynamic (PD) effects of TNO155 as a single agent and in combination with nazartinib

• Treatments

  Therapies:

  Therapy (NOS)

  Medications:

  TNO155 ()

• Inclusion Criteria

  Inclusion Criteria:
  • 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 applying to TNO155 in combination with EGF816 (nazartinib): Patients must be screened for Hepatitis B virus and Hepatitis C virus
  • Other criteria may apply

• Exclusion Criteria

  Exclusion Criteria:
  • 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.
  • 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. Additional criteria only appying to TNO155 in combination with EGF816 (nazartinib):
  • Patients with a known history of human immunodeficiency virus (HIV) seropositivity.
  • 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
  • Patients with a history or presence of interstitial lung disease or interstitial pneumonitis
  • Bullous and exfoliative skin disorders at screening of any grade
  • Presence of clinically significant ophthalmological abnormalities that might increase the risk of corneal epithelial injury
  • Additional criteria may apply

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