Study of TBio-6517 Given Alone or in Combination With Pembrolizumab in Solid Tumors (RAPTOR)
Solid Tumor, Microsatellite Stable Colorectal Cancer, HPV Positive Oropharyngeal Squamous Cell Carcinoma
About this trial
This is an interventional treatment trial for Solid Tumor focused on measuring Renal Cell, CRC, MSS-CRC, Oncolytic Virus, Intratumoral injection, HPV cancer, cervical cancer, mesothelioma, melanoma, skin cancer, oropharyngeal
Eligibility Criteria
Key Inclusion Criteria:
- Have a histologically or pathologically documented, locally-advanced or metastatic solid tumor for which standard curative measures do not exist or are no longer effective
- Measurable disease as per RECIST 1.1 criteria
- At least one tumor amenable to safe ITu injections and biopsies
- ECOG performance status 0 or 1
- Demonstrate adequate organ function
- Must be willing to comply with all protocol procedures and adhere to post-treatment care instructions
- Additional Inclusion criteria exist
For patients in phase 2 only: Have a histologically or cytologically confirmed advanced (metastatic and/or unresectable) solid tumor listed below, that is incurable and for which prior standard treatment has failed:
- Advanced (unresectable) or metastatic, intra or extra hepatic adenocarcinoma originating from the bile duct, CCA (Cohort 1) having progressed on at least 1 line of systemic therapy (including targeted therapy if eligible)
- Locally advanced or metastatic cutaneous melanoma (Cohort 2) that has failed anti-PD-1 or anti-PDL1 therapy (+/- anti-CTLA-4 therapy) and if BRAF+, having failed a BRAF/ +/-MEK inhibitor
- Locally advanced or metastatic cSCC (Cohort 3) that has not received systemic therapy (e.g., local resection or local topical therapy is permitted).
- Locally advanced or metastatic MSS-CRC (Cohort 4) patients that have progressed on at least 2 prior lines of systemic therapy which should include irinotecan and oxaliplatin +/- targeted therapy if warranted.
Key Exclusion Criteria:
- Prior systemic therapy, including experimental, surgery or radiation therapy within 4 weeks and must have recovered from acute toxicity.
- Prior treatment with any oncolytic virus.
- Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections.
- CNS metastases and/or carcinomatous meningitis that have not been completely resected or completely irradiated.
- Prior history of myocarditis
- Symptomatic or asymptomatic cardiovascular disease
- Known HIV/AIDS, active HBV or HCV infection.
- Received immunosuppressive medication within 4 weeks. (>10mg/day prednisone)
- Known intolerance to anti-PD-1 or anti-PD-L1 antibody therapy
- Additional Exclusion criteria exist
Sites / Locations
- Mayo Clinic
- Mayo Clinic
- Sylvester Comprehensive Cancer Center / UMHC
- University of Kansas Medical Center
- Clinical Site 1007
- Mayo Clinic
- The Billings Clinic
- University of Texas MD Anderson Cancer Center
- Ottawa Hospital and Research Institute (OHRI)
- National Cancer Center
- Seoul National University Hospital (SNUH)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm A: TBio-6517 alone
Arm B: TBio-6517 and Pembrolizumab
TBio-6517 and Pembrolizumab in MSS-CRC
TBio-6517 and Pembrolizumab in cutaneous melanoma
TBio-6517 and Pembrolizumab in cutaneous squamous cell carcinoma of the skin
TBio-6517 and Pembrolizumab in HPV positive head and neck cancer
Arm C: TBio-6517 intravenous
Arm D: TBio-6517 intravenous and Pembrolizumab
Dose escalation of TBio-6517 alone administered by direct injection into tumor(s) x 4. Booster injections of TBio-6517 are permitted for up to 24 months.
Dose escalation of TBio-6517 administered in combination with pembrolizumab. TBio-6517 will be directly injected into tumor(s) x 4. Booster injections of TBio-6517 are permitted for up to 24 months. Pembrolizumab will be administered beginning at Day 9 via intravenous (IV) infusion every 3 weeks for up to 24 months.
Doses of TBio-6517 will be administered by direct injection into tumor(s) x 4 in combination with pembrolizumab beginning at Day 9 given every 3 weeks for up to 24 months in patients with microsatellite stable colorectal carcinoma (MSS-CRC). Booster injections of TBio-6517 are permitted for up to 24 months.
Doses of TBio-6517 will be administered by direct injection into tumor(s) x 4 in combination with pembrolizumab beginning at Day 9 given every 3 weeks for up to 24 months in patients with malignant melanoma of the skin. Booster injections of TBio-6517 are permitted for up to 24 months.
Doses of TBio-6517 will be administered by direct injection into tumor(s) x 4 in combination with pembrolizumab beginning at Day 8 given every 3 weeks for up to 24 months in patients with cSCC. Booster injections of TBio-6517 are permitted for up to 24 months.
Doses of TBio-6517 will be administered by direct injection into tumor(s) x 4 in combination with pembrolizumab beginning at Day 9 given every 3 weeks for up to 24 months in patients with HPV associated oropharyngeal cancer. Booster injections of TBio-6517 are permitted for up to 24 months.
Dose escalation of TBio-6517 alone administered by intravenous infusion x 4. Booster infusions of TBio-6517 are permitted for up to 24 months.
Dose escalation of TBio-6517 administered in combination with pembrolizumab. Dose escalation of TBio-6517 alone administered by intravenous infusion x 4. Booster infusions of TBio-6517 are permitted for up to 24 months. Pembrolizumab will be administered beginning at Day 9 via intravenous (IV) infusion every 3 weeks for up to 24 months.