Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04000529
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TNO155 — DRUG
    Capsule
  • Spartalizumab — DRUG
    Concentrate for solution for infusion
  • Ribociclib — DRUG
    Capsule and tablet

Study Details

This study was a Phase Ib, multi-center, open-label study of TNO155 in combination with spartalizumab or ribociclib with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors. These two treatment arms enrolled subjects in parallel to characterize the safety, tolerability, PK, PD and preliminary antitumor activity. The study treatment was administered until the subject experienced unacceptable toxicity, progressive disease, and/or had treatment discontinued at the discretion of the Investigator or the subject, or due to withdrawal of consent.

Key Dates

Start date
Jul 30, 2019
Status verified
Sep 2025
Primary completion
Jan 15, 2024
Completion
Jan 15, 2024

Study Design

Enrollment
122 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TNO155 in combination with spartalizumab
    TNO155 in combination with spartalizumab
  • Experimental: TNO155 in combination with ribociclib
    TNO155 in combination with ribociclib

Primary Outcome Measure

DLT incidence [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

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