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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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights

RAPTOR Trial 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.

Eligible Conditions
  • Squamous Cell Carcinoma
  • Mesothelioma
  • Kidney Cancer
  • Oropharyngeal Cancer
  • Solid Tumors
  • Colorectal Cancer
  • Oropharyngeal Carcinoma
  • Cervical Cancer
  • Skin Cancer

RAPTOR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have a solid tumor that has spread and cannot be cured with standard treatments.
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Your disease can be measured using specific criteria.
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You have at least one tumor that can be safely injected and biopsied.
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You are able to perform regular daily activities or are mostly able to perform regular daily activities.
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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.

RAPTOR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
Median Disease Control Rate (DCR)
Median Duration of Response (DoR)
Median overall survival (OS)
+4 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

RAPTOR 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 2
~2010

Find a Location

Who is running the clinical trial?

Turnstone Biologics, Corp.Lead Sponsor
6 Previous Clinical Trials
124 Total Patients Enrolled
TakedaIndustry Sponsor
1,202 Previous Clinical Trials
4,178,235 Total Patients Enrolled
Justine Walker, MDStudy DirectorTurnstone Biologics, Corp.

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04301011 — Phase 1 & 2
Squamous Cell Carcinoma Research Study Groups: 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
Squamous Cell Carcinoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04301011 — Phase 1 & 2
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04301011 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of TBio-6517 Given Alone or in Combination With Pembrolizumab in Solid Tumors
2020. "Study of TBio-6517 Given Alone or in Combination With Pembrolizumab in Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04301011.
~6 spots leftby Apr 2025
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