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Report for Clinical Trial NCT04000529

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies

This study is 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 will enroll subjects in parallel to characterize the safety, tolerability, PK, PD and preliminary antitumor activity. The study treatment will be administered until the subject experiences unacceptable toxicity, progressive disease, and/or has treatment discontinued at the discretion of the Investigator or the subject, or due to withdrawal of consent.

NCT04000529 Non-small Cell Lung Carcinoma Head and Neck Squamous Cell Carcinoma Esophageal SCC Gastrointestinal Stromal Tumors Colorectal Cancer
MeSH:Carcinoma Squamous Cell Carcinoma of Head and Neck Gastrointestinal Stromal Tumors Carcinoma, Non-Small-Cell Lung Esophageal Squamous Cell Carcinoma
HPO:Carcinoma Gastrointestinal stroma tumor Non-small cell lung carcinoma

3 Interventions

Name: TNO155

Description: Capsule
Type: Drug
Group Labels: 2

TNO155 in combination with ribociclib TNO155 in combination with spartalizumab

Name: Spartalizumab

Description: Concentrate for solution for infusion
Type: Drug
Group Labels: 1

TNO155 in combination with spartalizumab

Name: Ribociclib

Description: Capsule and tablet
Type: Drug
Group Labels: 1

TNO155 in combination with ribociclib


Primary Outcomes

Description: Incidence of dose limiting toxicities (DLTs) during the first cycle of combination treatment during the dose escalation part

Measure: DLT incidence

Time: 1 year

Description: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as per CTCAE v5.0, by treatment

Measure: AE and SAE incidence

Time: 3 years

Description: Dose tolerability

Measure: Dose interruptions, reductions and dose intensity, by treatment

Time: 3 years

Secondary Outcomes

Description: Cmax for TNO155, spartalizumab, and ribociclib

Measure: Pharmacokinetics (PK): Cmax

Time: 3 years

Description: Tmax for TNO155, spartalizumab, and ribociclib

Measure: Pharmacokinetics (PK): Tmax

Time: 3 years

Description: AUClast for TNO155, spartalizumab, and ribociclib

Measure: Pharmacokinetics (PK): AUClast

Time: 3 years

Description: AUCtau for TNO155, spartalizumab, and ribociclib

Measure: Pharmacokinetics (PK): AUCtau

Time: 3 years

Description: Overall response rate (ORR) per RECIST v1.1, by treatment

Measure: Efficacy measurements per RECIST v1.1: ORR

Time: 3 years

Description: Disease control rate (DCR) per RECIST v1.1, by treatment

Measure: Efficacy measurements per RECIST v1.1: DCR

Time: 3 years

Description: Progression-free survival (PFS) per RECIST v1.1, by treatment

Measure: Efficacy measurements per RECIST v1.1: PFS

Time: 3 years

Description: Duration of response (DOR) per RECIST v1.1, by treatment

Measure: Efficacy measurements per RECIST v1.1: DOR

Time: 3 years

Description: Overall response rate (ORR) per iRECIST for TNO155 in combination with spartalizumab

Measure: Efficacy measurements per iRECIST: ORR

Time: 3 years

Description: Disease control rate (DCR) per iRECIST for TNO155 in combination with spartalizumab

Measure: Efficacy measurements per iRECIST: DCR

Time: 3 years

Description: Progression-free survival (PFS) per iRECIST for TNO155 in combination with spartalizumab

Measure: Efficacy measurements per iRECIST: PFS

Time: 3 years

Description: Duration of response (DOR) per iRECIST for TNO155 in combination with spartalizumab

Measure: Efficacy measurements per iRECIST: DOR

Time: 3 years

Description: Overall survival (OS) by treatment

Measure: Overall Survival

Time: 3 years

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 G12C

For TNO155 plus spartalizumab combination: i. Advanced EGFR WT, ALK WT, KRAS G12C NSCLC after progression on or intolerance to platinum-containing combination chemotherapy and after progression on anti-PD-1 or anti-PD-L1 therapy. --- G12C ---



HPO Nodes


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