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TBio-6517 for Breast Cancer

Sylvester Comprehensive Cancer Center / UMHC, Miami, FL
Breast Cancer+9 More ConditionsTBio-6517 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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
  • Breast Cancer
  • Cervical Cancer
  • Kidney Cancer
  • Oropharyngeal Cancers
  • Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma
  • Solid Tumors
  • Skin Cancer
  • Skin Squamous Cell Carcinoma
  • Mesothelioma
  • Microsatellite Stable Colorectal Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

Similar Trials

1
CT-0508
1
RM-1995
1
ASN004

Study Objectives

5 Primary · 7 Secondary · Reporting Duration: 48 months

25 months
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
Median Disease Control Rate (DCR)
Median Duration of Response (DoR)
Median progression free survival
Number and severity of adverse events at the RP2D
Percentage of overall response rate (ORR) by RECIST 1.1 at the RP2D
Percentage of overall response rate (ORR) by immunotherapy RECIST (iRECIST) at the RP2D
Proportion of patients with a response (ORR)
Neoplasms
4 weeks
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.
48 months
Median overall survival (OS)

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
CT-0508
1
RM-1995
1
ASN004

Side Effects for

Arm A (Phased Pembrolizumab Regimen)
71%Fatigue
43%Peripheral sensory neuropathy
38%Alopecia
38%Headache
33%Nausea
29%Cough
29%Dyspnea
29%Hypothyroidism
29%Pain
24%Constipation
24%Rash maculo-papular
19%Anorexia
19%Diarrhea
19%Abdominal pain
19%Infusion related reaction
19%Pain in extremity
19%Bloating
19%Dyspepsia
14%Anemia
14%Sinusitis
14%Hyperglycemia
14%Dehydration
14%Allergic rhinitis
14%Nasal congestion
14%Edema limbs
14%Hypokalemia
10%Lymphedema
10%Skin infection
10%Restlessness
10%Neutrophil count decreased
10%Myalgia
10%Fall
10%Pruritus
10%Localized edema
10%Dry mouth
10%Mucositis oral
10%Vomiting
10%Alanine aminotransferase increased
10%Pneumonitis
10%Hoarseness
10%Thromboembolic event
10%Hot flashes
10%Hyperthyroidism
10%Chills
10%Aspartate aminotransferase increased
10%Back pain
10%Dizziness
10%Flushing
5%Postnasal drip
5%Hypotension
5%Atrial flutter
5%Alkaline phosphatase increased
5%Hepatic failure
5%Lymph gland infection
5%Lung infection
5%Syncope
5%Sneezing
5%Respiratory failure
5%Eye disorders - Other, specify
5%Non-cardiac chest pain
5%Hepatobiliary disorders - Other, specify
5%Infections and infestations - Other, specify
5%Hypophosphatemia
5%Metabolism and nutrition disorders - Other, specify
5%Recurrent laryngeal nerve palsy
5%Urinary tract pain
5%Urinary urgency
5%Epistaxis
5%Hypoxia
5%Sore throat
5%Nail ridging
5%Skin hyperpigmentation
5%Upper respiratory infection
5%Nail infection
5%Hypoglycemia
5%Mucosal infection
5%Fever
5%Malaise
5%Urinary frequency
5%Urinary incontinence
5%Hypertension
5%Nail loss
5%Insomnia
5%Bruising
5%Blood bilirubin increased
5%Creatinine increased
5%Dysgeusia
5%Laryngeal hemorrhage
5%Hyponatremia
5%Periorbital edema
5%Gastrointestinal disorders - Other
5%Urinary tract infection
5%Platelet count decreased
5%Bone pain
5%Conjunctivitis
5%Flashing lights
5%Allergic reaction
5%Hypocalcemia
5%Hypomagnesemia
This histogram enumerates side effects from a completed 2022 Phase 2 trial (NCT03018080) in the Arm A (Phased Pembrolizumab Regimen) ARM group. Side effects include: Fatigue with 71%, Peripheral sensory neuropathy with 43%, Alopecia with 38%, Headache with 38%, Nausea with 33%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

9 Treatment Groups

Arm A: TBio-6517 alone
1 of 9
Arm B: TBio-6517 and Pembrolizumab
1 of 9
TBio-6517 and Pembrolizumab in cutaneous melanoma
1 of 9
TBio-6517 and Pembrolizumab in cutaneous squamous cell carcinoma of the skin
1 of 9
TBio-6517 and Pembrolizumab in HPV positive head and neck cancer
1 of 9
Arm C: TBio-6517 intravenous
1 of 9
Arm D: TBio-6517 intravenous and Pembrolizumab
1 of 9
TBio-6517 and Pembrolizumab in TNBC
1 of 9
TBio-6517 and Pembrolizumab in MSS-CRC
1 of 9

Experimental Treatment

27 Total Participants · 9 Treatment Groups

Primary Treatment: TBio-6517 · No Placebo Group · Phase 1 & 2

Arm A: TBio-6517 alone
Biological
Experimental Group · 1 Intervention: TBio-6517 · Intervention Types: Biological
Arm B: TBio-6517 and PembrolizumabExperimental Group · 2 Interventions: Pembrolizumab, TBio-6517 · Intervention Types: Biological, Biological
TBio-6517 and Pembrolizumab in cutaneous melanomaExperimental Group · 2 Interventions: Pembrolizumab, TBio-6517 · Intervention Types: Biological, Biological
TBio-6517 and Pembrolizumab in cutaneous squamous cell carcinoma of the skinExperimental Group · 2 Interventions: Pembrolizumab, TBio-6517 · Intervention Types: Biological, Biological
TBio-6517 and Pembrolizumab in HPV positive head and neck cancerExperimental Group · 2 Interventions: Pembrolizumab, TBio-6517 · Intervention Types: Biological, Biological
Arm C: TBio-6517 intravenous
Biological
Experimental Group · 1 Intervention: TBio-6517 · Intervention Types: Biological
Arm D: TBio-6517 intravenous and PembrolizumabExperimental Group · 2 Interventions: Pembrolizumab, TBio-6517 · Intervention Types: Biological, Biological
TBio-6517 and Pembrolizumab in TNBCExperimental Group · 2 Interventions: Pembrolizumab, TBio-6517 · Intervention Types: Biological, Biological
TBio-6517 and Pembrolizumab in MSS-CRCExperimental Group · 2 Interventions: Pembrolizumab, TBio-6517 · Intervention Types: Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 48 months

Who is running the clinical trial?

Turnstone Biologics, Corp.Lead Sponsor
5 Previous Clinical Trials
79 Total Patients Enrolled
1 Trials studying Breast Cancer
30 Patients Enrolled for Breast Cancer
TakedaIndustry Sponsor
1,144 Previous Clinical Trials
4,057,506 Total Patients Enrolled
3 Trials studying Breast Cancer
3,585 Patients Enrolled for Breast Cancer
Justine Walker, MDStudy DirectorTurnstone Biologics, Corp.
Ines Verdon, MDStudy DirectorTurnstone Biologics
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Breast Cancer
30 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a solid tumor that has spread or is advanced, and there are no standard treatments available that can cure it.
There are more requirements that you need to meet to participate in the study.
You have an advanced and incurable solid tumor that has failed prior standard treatment. The specific types of tumors included are: bile duct adenocarcinoma, cutaneous melanoma that has failed anti-PD-1 or anti-PDL1 therapy, locally advanced or metastatic cutaneous squamous cell carcinoma that has not received systemic therapy, and metastatic microsatellite stable colorectal cancer that has progressed on at least two prior lines of systemic therapy.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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