A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Carcinoma Non-small-cell Lung
- Squamous Cell Carcinoma of Head and Neck
- Triple Negative Breast Neoplasms
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The drug being tested in this study is called TAK-676. This study will evaluate the safety, tolerability and preliminary antitumor activity of TAK-676 with pembrolizumab following radiation therapy in the treatment of advanced NSCLC, TNBC, or SCCHN that has progressed on checkpoint inhibitors (CPIs)...
The drug being tested in this study is called TAK-676. This study will evaluate the safety, tolerability and preliminary antitumor activity of TAK-676 with pembrolizumab following radiation therapy in the treatment of advanced NSCLC, TNBC, or SCCHN that has progressed on checkpoint inhibitors (CPIs) and will estimate the maximum tolerated dose (MTD) and determine the recommended phase 2 dose (RP2D) of this combination. The study will enroll approximately 46 participants. Participants will be assigned to dose escalating cohorts based on Bayesian Optimal Interval (BOIN) design. The starting dose of TAK-676 will be 0.2 mg and the subsequent dosing will be initiated based on the available safety and tolerability data from the previous cohort. This multi-center trial will be conducted in the United States. There will be many clinic visits. The number of visits will depend on the number of cycles of treatment. Participants will attend an end of treatment (EOT) visit 30 days after receiving their last dose of study drug or before the start of subsequent systemic anticancer therapy, whichever occurs first. They might continue to have check-ups every 12 weeks if they left the study for a reason apart from their cancer getting worse.
Tracking Information
- NCT #
- NCT04879849
- Collaborators
- Not Provided
- Investigators
- Study Director: Study Director Takeda