Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies (NCT04000529) | Clinical Trial Compass
TerminatedPhase 1
Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies
Stopped: Business reasons
United States, Australia, Belgium122 participantsStarted 2019-07-30
Plain-language summary
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.
Who can participate
Age range18 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
✓. Signed informed consent must be obtained prior to participation in the study.
✓. Age ≥ 18 years. For Japan only: written consent is necessary both from the patient and his/her legal representative if he/she is under the age of 20 years.
✓. ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1.
✓. Dose escalation part: Patients with advanced solid tumors, with evaluable disease as determined by RECIST version 1.1, and fit into one of the following groups:
Exclusion criteria
✕. Dose expansion part: Patients with advanced solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who fit into one of the following groups:
✕. Patients with NSCLC whose tumors harbor genomic aberrations for which SOC targeted therapies exist and are locally approved and available must have had progression on or after, or intolerance to, the SOC targeted therapy/therapies as indicated
✕. Patients must have a site of disease amenable to biopsy
✕
What they're measuring
1
DLT incidence
Timeframe: 1 year
2
AE and SAE incidence
Timeframe: 3 years
3
Dose interruptions, reductions and dose intensity, by treatment
✕. Clinically significant cardiac disease or risk factors
✕. Use of any agent known to prolong the QT interval unless it can be permanently discontinued for the duration of study (see list in Section 6.2.2).
✕. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO
✕. Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drugs