Study Summary
This trial is testing a new cancer drug, TBio-6517, to see what dose is effective when given by injection into tumors or intravenously, either alone or with another cancer drug, pembrolizumab.
- Breast Cancer
- Cervical Cancer
- Kidney Cancer
- Oropharyngeal Cancers
- Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma
- Solid Tumors
- Skin Cancer
- Skin Squamous Cell Carcinoma
- Mesothelioma
- Microsatellite Stable Colorectal Cancer
Treatment Effectiveness
Study Objectives
5 Primary · 7 Secondary · Reporting Duration: 48 months
Trial Safety
Side Effects for
Awards & Highlights
Trial Design
9 Treatment Groups
Arm A: TBio-6517 alone
1 of 9
Arm B: TBio-6517 and Pembrolizumab
1 of 9
TBio-6517 and Pembrolizumab in cutaneous melanoma
1 of 9
TBio-6517 and Pembrolizumab in cutaneous squamous cell carcinoma of the skin
1 of 9
TBio-6517 and Pembrolizumab in HPV positive head and neck cancer
1 of 9
Arm C: TBio-6517 intravenous
1 of 9
Arm D: TBio-6517 intravenous and Pembrolizumab
1 of 9
TBio-6517 and Pembrolizumab in TNBC
1 of 9
TBio-6517 and Pembrolizumab in MSS-CRC
1 of 9
Experimental Treatment
27 Total Participants · 9 Treatment Groups
Primary Treatment: TBio-6517 · No Placebo Group · Phase 1 & 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
What conditions has TBio-6517 been prescribed for most frequently?
"TBio-6517 is frequently prescribed to mitigate malignant neoplasms, as well as unresectable melanomas, and microsattellite instability high conditions that have progressed after chemotherapy." - Anonymous Online Contributor
To what extent is this trial being implemented in medical facilities?
"This trial is available at 9 different medical facilities, including the Mayo Clinic in Rochester, Clinical Site 1007 in Phoenix, and University of Kansas Medical Centre in Boston." - Anonymous Online Contributor
Are there any openings for participants in this trial currently?
"According to the information located on clinicaltrials.gov, this study is presently recruiting patients and it has been open since June 2nd 2020 with the latest update being released on February 21st 2022." - Anonymous Online Contributor
What prior research has been done involving TBio-6517?
"At this moment in time, 961 live clinical trials for TBio-6517 are underway. Of these, 122 have reached Phase 3 testing. Though many of the studies take place in Houston, Texas - there are over 35 thousand sites conducting research around the world." - Anonymous Online Contributor
How many subjects have enrolled in this research project?
"The trial sponsor, Takeda, has mandated that a total of 138 participants meeting the inclusion criteria need to be enrolled. The sites responsible for administering this study include Mayo Clinic in Rochester and Clinical Site 1007 situated in Phoenix." - Anonymous Online Contributor
What outcomes does this research endeavor hope to accomplish?
"The principal objective of this medical experiment, which will be monitored for a duration of 25 months, is to detect any adverse events associated with the administration of TBio-6517 combined with pembrolizumab. Additionally, metrics such as Disease Control Rate (DCR), Objective Response Rate (ORR) and Duration of Response (DoR) shall also be measured in order to gain further insight into the efficacy of this treatment regime." - Anonymous Online Contributor