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Solid TumorPhase 1RAPTORNCT04301011

Study of TBio-6517 Given Alone or in Combination With Pembrolizumab in Solid Tumors

A Phase 1 study testing TBio-6517 and Pembrolizumab in people with Solid Tumor and Microsatellite Stable Colorectal Cancer, run by Turnstone Biologics, Corp. at 11 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 (RIVAL-01). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TBio-6517 and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
11 sitesin 3 countries
Study dates
2 Jun 2020to 23 Jan 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

11 sites in 3 countries.

11 sites in 3 countries

United States8 sites

  • The Billings Clinic

    Billings, Montana, 31031

  • Clinical Site 1007

    Boston, Massachusetts, 02215

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of Kansas Medical Center

    Kansas City, Kansas, 66205

  • Sylvester Comprehensive Cancer Center / UMHC

    Miami, Florida, 33136

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • Mayo Clinic

    Rochester, Minnesota, 55902

Other trials in United States

South Korea2 sites

  • National Cancer Center

    Ilsandong, 10408

  • Seoul National University Hospital (SNUH)

    Junggu, 03080

Other trials in South Korea

Canada1 site

  • Ottawa Hospital and Research Institute (OHRI)

    Ottawa, Ontario

Other trials in Canada

About this study

Official title: A Phase 1/2a, Multicenter, Open-label Trial of TBio-6517, an Oncolytic Vaccinia Virus, Administered Alone and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors

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 (RIVAL-01).

Read the 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 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.

Being tested
TBio-6517, Pembrolizumab
Keywords
Renal Cell, CRC, MSS-CRC, Oncolytic Virus, Intratumoral injection, HPV cancer, cervical cancer, mesothelioma, melanoma, skin cancer, oropharyngeal
Medical subject headings
Uterine Cervical Neoplasms, Melanoma, Mesothelioma, Carcinoma, Renal Cell, Oropharyngeal Neoplasms, Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TBio-6517Biological

    Also called RIVAL-01

    Engineered Oncolytic Vaccinia Virus

  • PembrolizumabBiological

    Also called Keytruda

    Immune checkpoint inhibitor.

Study groups in NCT04301011
Study groupRoleWhat they receive
Arm A: TBio-6517 aloneExperimentalDose 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.
Receives: Biological: TBio-6517
Arm B: TBio-6517 and PembrolizumabExperimentalDose 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.
Receives: Biological: TBio-6517; Biological: Pembrolizumab
TBio-6517 and Pembrolizumab in MSS-CRCExperimentalDoses 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.
Receives: Biological: TBio-6517; Biological: Pembrolizumab
TBio-6517 and Pembrolizumab in cutaneous melanomaExperimentalDoses 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.
Receives: Biological: TBio-6517; Biological: Pembrolizumab
TBio-6517 and Pembrolizumab in cutaneous squamous cell carcinoma of the skinExperimentalDoses 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.
Receives: Biological: TBio-6517; Biological: Pembrolizumab
TBio-6517 and Pembrolizumab in HPV positive head and neck cancerExperimentalDoses 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.
Receives: Biological: TBio-6517; Biological: Pembrolizumab
Arm C: TBio-6517 intravenousExperimentalDose escalation of TBio-6517 alone administered by intravenous infusion x 4. Booster infusions of TBio-6517 are permitted for up to 24 months.
Receives: Biological: TBio-6517
Arm D: TBio-6517 intravenous and PembrolizumabExperimentalDose 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.
Receives: Biological: TBio-6517; Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events when TBio-6517 administered by direct injection into tumor(s) alone at each dose level

    Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0

    Measured: 25 months

  2. Incidence of adverse events when TBio-6517 administered by direct injection into tumor(s) when combined with pembrolizumab

    Percentage of patients with adverse events by severity as determined by NCI CTCAE v5.0

    Measured: 25 months

  3. 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.

    The highest dose of TBio-6517 that can be administered where fewer than 2 patients have a dose-limiting safety event alone or when combined with pembrolizumab as assessed by NCI CTCAE v.5.0 during the Phase 1 dose escalation

    Measured: 4 weeks

  4. Percentage of overall response rate (ORR) by RECIST 1.1 at the RP2D

    Percentage of patients treated at the RP2D in combination with pembrolizumab with a partial response or complete response by RECIST 1.1 following central radiologist review

    Measured: 25 months

  5. Percentage of overall response rate (ORR) by immunotherapy RECIST (iRECIST) at the RP2D

    Percentage of patients treated at the RP2D with pembrolizumab with a partial response (PR) or complete response (CR) by iRECIST following central radiologist review

    Measured: 25 months

Secondary outcomes (7)

  1. Number and severity of adverse events at the RP2D

    Number of patients with adverse events by severity and frequency as determined by NCI CTCAE v5.0

    Measured: 25 months

  2. Median overall survival (OS)

    Median overall survival in months in patients

    Measured: 48 months

  3. Median Duration of Response (DoR)

    Median duration of response in patients with a CR or PR

    Measured: 25 months

  4. Proportion of patients with a response (ORR)

    Percentage of patients in all arms with a CR or PR as assessed by the central radiologist using RECIST 1.1 and iRECIST

    Measured: 25 months

  5. Median Disease Control Rate (DCR)

    Median duration of response in patients with a CR, PR, or stable disease (SD)

    Measured: 25 months

  6. Time to tumor progression (TTP)

    Median time until patient disease progression (PD)

    Measured: 25 months

  7. Median progression free survival

    Median duration of progression free survival of patients

    Measured: 25 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2020
  2. Study start2 Jun 2020
  3. Primary completion23 Jan 2023
  4. Study completion23 Jan 2023

Why it stopped: Sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04301011
Sponsor's protocol ID
TBio-6517-ITu-001
Acronym
RAPTOR
Status last verified
Apr 2025
First submitted
4 Mar 2020
Last updated
23 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TBio-6517 and Pembrolizumab in people with Solid Tumor and Microsatellite Stable Colorectal Cancer, run by Turnstone Biologics, Corp. at 11 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, South Korea, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events when TBio-6517 administered by direct injection into tumor(s) alone at each dose level (time frame: 25 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04301011.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.

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