NCT02834247

A Study of TAK-659 in Combination With Nivolumab in Participants With Advanced Solid Tumors

A Phase 1b Study to Evaluate TAK-659 in Combination With Nivolumab in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Calithera Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), safety and efficacy of TAK-659 in combination with nivolumab in participants with advanced solid tumors.

Detailed description

The drug being tested is TAK-659.This study will look at the determination of the MTD/RP2D and efficacy measured by ORR in participants who take TAK-659 in combination with nivolumab. The study will include a dose escalation phase (Part 1), a potential nivolumab fixed dose cohort, and a dose expansion phase (Part 2). The study will enroll approximately 120 participants, approximately 9-12 in the dose escalation phase and approximately 36 in each of the 3 dose expansion cohorts. Participants will be assigned to 1 of the 4 treatment groups: * Part 1: Advanced Solid Tumors * Potential Nivolumab Fixed Dose Cohort * Part 2: Metastatic TNBC * Part 2: Metastatic NSCLC * Part 2: Metastatic HNSCC All participants will be asked to take the tablets of TAK-659 at the same time each day throughout the study. Participants will also receive intravenous infusion of nivolumab (within 30 minutes after the TAK-650 dose) once every 2 weeks. This multi-center trial will be conducted globally. The overall time to receive treatment in this study is approximately 12 months. Participants will be assessed for disease response and PD during the PFS follow-up of 6 months (for participants who discontinue due to reasons other than PD) and OS follow-up of 12 months from the last dose of study drug.

Conditions

• Triple-Negative Breast Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Head and Neck Carcinoma, Squamous Cell
• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	TAK-659	TAK-659 Tablets.
DRUG	Nivolumab	Nivolumab intravenous infusion.

Timeline

• Start date: 2016-08-12
• Primary completion: 2018-11-30
• Completion: 2018-11-30
• First posted: 2016-07-15
• Last updated: 2023-02-08
• Results posted: 2020-03-31

Locations

22 sites across 4 countries: United States, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study