Status:
TERMINATED
Study of TBio-6517 Given Alone or in Combination With Pembrolizumab in Solid Tumors
Lead Sponsor:
Turnstone Biologics, Corp.
Collaborating Sponsors:
Takeda
Conditions:
Solid Tumor
Microsatellite Stable Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To determine the recommended Phase 2 dose (RP2D) of TBio-6517 when administered by direct injection into tumor(s) or intravenously and when combined with pembrolizumab in patients with solid tumors (R...
Detailed Description
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 determin...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
June 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2023
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04301011
Start Date
June 2 2020
End Date
January 23 2023
Last Update
April 23 2025
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Phoenix, Arizona, United States, 85054
2
Mayo Clinic
Jacksonville, Florida, United States, 32224
3
Sylvester Comprehensive Cancer Center / UMHC
Miami, Florida, United States, 33136
4
University of Kansas Medical Center
Kansas City, Kansas, United States, 66205