TerminatedPhase 1

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

Stopped: Business reasons and not due to any safety concerns

United States, Canada227 participantsStarted 2017-05-26

Plain-language summary

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.

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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
✓. Patients must be screened for Hepatitis B virus and Hepatitis C virus

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.

What they're measuring

Number of participants with adverse events and serious adverse events

Timeframe: up to 5 years; at least once per treatment cycle

Number of participants with dose limiting toxicities

Timeframe: up to 28-day cycle

Number of participants with dose interruptions and reductions

Timeframe: Up to 5 years

Dose intensity of study drugs

Timeframe: Up to 5 years

Trial details

NCT IDNCT03114319

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-04

View on ClinicalTrials.gov More Advanced EGFR Mutant Non Small Cell LungCancer (NSCLC) trials

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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
✓. Patients must be screened for Hepatitis B virus and Hepatitis C virus

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.

What they're measuring

Number of participants with adverse events and serious adverse events

Timeframe: up to 5 years; at least once per treatment cycle

Number of participants with dose limiting toxicities

Timeframe: up to 28-day cycle

Number of participants with dose interruptions and reductions

Timeframe: Up to 5 years

Dose intensity of study drugs

Timeframe: Up to 5 years