A Study of TAK-676 and TAK-676 in Combination With Pembrolizumab in Adults With Advanced Solid Tumours

Official Title

An Open-label, Dose Escalation, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-676 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced or Metastatic Solid Tumours

Summary:

It is hoped that TAK-676, when given on its own or given with pembrolizumab will eventually help people with advanced or metastatic solid tumours. The main aim of this study is to check if people with advanced solid tumours have side effects from TAK-676, and to check how much TAK-676 they can receive without getting side effects from it. At the first visit, the study doctor will check who can take part. Participants will receive TAK-676 slowly through a vein (infusion). This will happen on 3 different days during a 21-day cycle. Different small groups of participants will receive lower to higher doses of TAK-676. Some participants will receive TAK-676 by itself and others will receive TAK-676 with pembrolizumab. Participants will stay in the clinic or hospital for 24 hours after each infusion of TAK-676 in the first cycle of treatment. Sometimes the study doctor will carry out a physical exam before the participant goes home. Participants will be given an emergency card to carry with them at all times. The card has information about the study including contact details and a 24-hour emergency number. Some participants, who receive TAK-676 and are willing and able, will be asked to wear a removable patch on their chest to record vital signs for 21 days in the first cycle of treatment. Also, in the first cycle of treatment, participants will record their oral temperatures twice a day for 21 days in a diary when they go home after each infusion. Throughout treatment, the clinic will regularly telephone the participants to check on their health.

Trial Description

Primary Outcome:

• Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity
• Number of Participants with Dose-Limiting Toxicities (DLTs)
• Number of Participants Reporting One or More Treatment Emergent Serious Adverse Event (SAEs)
• Number of Participants With one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations

• Cmax: Maximum Observed Plasma Concentration for TAK-676
• Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-676
• AUCt: Area under the Concentration-time Curve From Time 0 to Time t for TAK-676
• AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity for TAK-676
• t1/2: Terminal Disposition Phase Half-life for TAK-676
• CL: Total Clearance After Intravenous Administration for TAK-676
• Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-676
• CLR: Renal Clearance for TAK-676
• Percentage of Dose Excreted in Urine During 24 Hours After Dosing
• CLR/CL%: Renal Clearance as Percentage of Total Clearance for TAK-676
• Overall Response Rate (ORR)
• Disease Control Rate (DCR)
• Duration of Response (DOR)
• Time to Response (TTR)
• Number of Participants with Upregulation of TAK-676-Induced Stimulator of Interferon Genes (STING)

View this trial on ClinicalTrials.gov