Study of TBio-6517 Given Alone or in Combination With Pembrolizumab in Solid Tumors
Mayo Clinic, Phoenix, Arizona, United States|Mayo Clinic, Jacksonville, Florida, United States|Sylvester Comprehensive Cancer Center / UMHC, Miami, Florida, United States|University of Kansas Medical Center, Kansas City, Kansas, United States|Clinical Site 1007, Boston, Massachusetts, United States|Mayo Clinic, Rochester, Minnesota, United States|The Billings Clinic, Billings, Montana, United States|University of Texas MD Anderson Cancer Center, Houston, Texas, United States|Ottawa Hospital and Research Institute (OHRI), Ottawa, Ontario, Canada|National Cancer Center, Ilsandong, Korea, Republic of|Seoul National University Hospital (SNUH), Junggu, Korea, Republic of
Biological: TBio-6517|Biological: Pembrolizumab
This is a Phase 1/2a dose escalation study with TBio-6517 administered by direct injection into tumor(s) or by intravenous infusion. The Phase 1 portion has 4 arms; the first arm (Arm A) will determine the RP2D of TBio-6517 alone when directly injected into tumor(s), and the second arm (Arm B) will determine the RP2D of TBio-6517 when combined with pembrolizumab. The third and fourth arms will determine the RP2D of TBio-6517 when given intravenously alone and with pembrolizumab, respectively.
In the Phase 2a portion, the clinical benefit of TBio-6517 combined with pembrolizumab will be further explored in patients with Microsatellite Stable Colorectal Cancer (MSS-CRC), Cholangiocarcinoma (CCA), Cutaneous Melanoma, and Cutaneous Squamous Cell Carcinoma of the Skin (cSCC), as assessed by overall response rate (ORR) from central radiology review.