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Clinical Trial 22009

Cancer Type: Cutaneous
Study Type: Treatment
NCT#: NCT03114319

Phase: Phase I
Principal Investigator: Tarhini, Ahmad

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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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