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Checkpoint Inhibitor
TBio-6517 + Pembrolizumab for Solid Tumors (RAPTOR Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by Turnstone Biologics, Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug, TBio-6517, alone and with another medication in patients with certain solid tumors. It aims to find the best dose and see if the combination helps the immune system fight cancer better.
Eligible Conditions
- Mesothelioma
- Skin Cancer
- Kidney Cancer
- Oropharyngeal Cancer
- Solid Tumors
- Colorectal Cancer
- Oropharyngeal Carcinoma
- Cervical Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events when TBio-6517 administered by direct injection into tumor(s) alone at each dose level
Incidence of adverse events when TBio-6517 administered by direct injection into tumor(s) when combined with pembrolizumab
Maximum tolerated dose (MTD) or Maximum feasible dose (MFD) and determination of the recommended Phase 2 dose (RP2D) of TBio-6517 alone and in combination with pembrolizumab.
+2 moreSecondary study objectives
Median Disease Control Rate (DCR)
Median Duration of Response (DoR)
Median overall survival (OS)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Group I: TBio-6517 and Pembrolizumab in cutaneous squamous cell carcinoma of the skinExperimental Treatment2 Interventions
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.
Group II: TBio-6517 and Pembrolizumab in cutaneous melanomaExperimental Treatment2 Interventions
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.
Group III: TBio-6517 and Pembrolizumab in MSS-CRCExperimental Treatment2 Interventions
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.
Group IV: TBio-6517 and Pembrolizumab in HPV positive head and neck cancerExperimental Treatment2 Interventions
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.
Group V: Arm D: TBio-6517 intravenous and PembrolizumabExperimental Treatment2 Interventions
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.
Group VI: Arm C: TBio-6517 intravenousExperimental Treatment1 Intervention
Dose escalation of TBio-6517 alone administered by intravenous infusion x 4. Booster infusions of TBio-6517 are permitted for up to 24 months.
Group VII: Arm B: TBio-6517 and PembrolizumabExperimental Treatment2 Interventions
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.
Group VIII: Arm A: TBio-6517 aloneExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3150
Find a Location
Who is running the clinical trial?
Turnstone Biologics, Corp.Lead Sponsor
6 Previous Clinical Trials
124 Total Patients Enrolled
TakedaIndustry Sponsor
1,238 Previous Clinical Trials
4,148,991 Total Patients Enrolled
1 Trials studying Mesothelioma
313 Patients Enrolled for Mesothelioma
Justine Walker, MDStudy DirectorTurnstone Biologics, Corp.
Ines Verdon, MDStudy DirectorTurnstone Biologics
1 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had inflammation of the heart muscle before.You have any type of heart or blood vessel disease, even if you don't have any symptoms.You have a solid tumor that has spread and cannot be cured with standard treatments.You have received treatment with any type of oncolytic virus before.You have cancer that has spread to the brain or the lining of the brain, and it has not been completely removed or treated with radiation.You have HIV/AIDS, active hepatitis B, or active hepatitis C infection.Your disease can be measured using specific criteria.You have at least one tumor that can be safely injected and biopsied.You are able to perform regular daily activities or are mostly able to perform regular daily activities.You have had a bad reaction to anti-PD-1 or anti-PD-L1 antibody treatment before.You have taken medication that weakens your immune system within the last 4 weeks.For phase 2 patients only: You have a confirmed advanced, incurable solid tumor from the bile duct, cutaneous melanoma, cutaneous squamous cell carcinoma, or colorectal cancer that has not responded to standard treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: TBio-6517 alone
- Group 2: Arm B: TBio-6517 and Pembrolizumab
- Group 3: TBio-6517 and Pembrolizumab in MSS-CRC
- Group 4: TBio-6517 and Pembrolizumab in cutaneous melanoma
- Group 5: TBio-6517 and Pembrolizumab in cutaneous squamous cell carcinoma of the skin
- Group 6: TBio-6517 and Pembrolizumab in HPV positive head and neck cancer
- Group 7: Arm C: TBio-6517 intravenous
- Group 8: Arm D: TBio-6517 intravenous and Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.