Breast CancerPhase 1STARLINGNCT05576077
A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors
A Phase 1 study testing TBio-4101 and Pembrolizumab in people with Breast Cancer and Colorectal Cancer, run by Turnstone Biologics, Corp. at 13 sites in 2 countries.
Trial summary
A multicenter trial to investigate TBio-4101, an autologous, neoantigen-selected, tumor-reactive TIL product, in patients with advanced solid malignancies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Uveal Melanoma
- What is being tested?
- TBio-4101 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 17 Jan 2023to 24 Feb 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced or metastatic breast carcinoma, colorectal adenocarcinoma, uveal melanoma, cutaneous melanoma, non-small cell lung cancer, or head and neck squamous cell carcinoma that has failed or is refractory to standard of care therapy
- Have at least one target lesion that can be used for response assessments and have at least 1 tumor amenable for tissue harvest for TIL manufacturing.
- ECOG performance status of 0 or 1
- Demonstrate adequate organ function
- Additional inclusion criteria exist
Who cannot join
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy or any other form of immunosuppressive
- Currently infected with HIV Type 1 and Type 2, hepatitis B virus (HBV), hepatitis C virus (HCV), treponema pallidum (e.g., syphilis), West Nile virus (WNV), Human T-lymphotropic virus types 1 or II (HTLV I/II), or cytomegalovirus (CMV)
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable
- Serious cardiac condition, such as uncontrolled hypertension, concurrent congestive heart failure, prior history of Class III/IV cardiac disease (New York Heart Association [NYHA]), history of cardiac ischemia within the past 6 months, or prior history of cardiac arrhythmia requiring treatment. Patients who are > 60 years of age must undergo cardiology clearance exam and cardiac stress test.
- Prior cell therapy or organ transplant
Show all 11Show fewer
- History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, IL-2, or pembrolizumab, or any of their constituents
- LVEF ≤ 45%
- FEV1 ≤ 60% of predicted value and DLCO (corrected) < 60% of predicted value
- Chronic anti-coagulant therapy that cannot either be discontinued or temporarily changed
- Additional exclusion criteria exist
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States11 sites
University of Chicago
Chicago, Illinois, 60637
Memorial Healthcare System
Hollywood, Florida, 33021
MD Anderson Cancer Center
Houston, Texas, 77030
University of California Irvine
Irvine, California, 92868
Norton Cancer Institute
Louisville, Kentucky, 40202
University of Miami
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Orlando Health
Orlando, Florida, 32806
Allegheny Research Institute
Pittsburgh, Pennsylvania, 15224
Providence Cancer Institute
Portland, Oregon, 97213
Moffitt Cancer Center
Tampa, Florida, 33612-9497
Canada2 sites
Montreal University Hospital Center
Montreal, Quebec, H2X 0C1
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C1
About this study
Official title: A Phase 1b Study of TBio-4101 (Autologous Selected and Expanded Tumor-Infiltrating Lymphocytes [TIL]) and Pembrolizumab in Patients With Advanced Solid Tumor Malignancies (STARLING)
A multicenter trial to investigate TBio-4101, an autologous, neoantigen-selected, tumor-reactive TIL product, in patients with advanced solid malignancies.
Read the detailed description
This is a Phase 1 study to investigate TBio-4101. TBio-4101 is an autologous tumor infiltrating lymphocyte (TIL) therapy that utilizes tumor specific antigens to select, sort, and expand patient-specific tumor-reactive T-cells to be reinfused into the patient. The adoptive cell therapy is further enhanced through the use of non-myeloablative chemotherapy prior to TIL infusion, followed by the TIL plus IL-2 infusion. Low-dose radiation therapy is administered prior to and after TIL plus IL-2 infusion. Pembrolizumab is provided after the resolution of IL-2 toxicities. The trial is open to solid tumors of varying tumor mutational burdens.
- Conditions
- Breast Cancer, Colorectal Cancer, Uveal Melanoma, Cutaneous Melanoma, Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
- Being tested
- TBio-4101, Pembrolizumab
- Keywords
- MSS-CRC, TIL, Tumor infiltrating lymphocyte, TNBC, HR+ Breast, ER+ Breast, MSI-CRC, personalized medicine, ocular melanoma
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Uveal Melanoma, Melanoma, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBio-4101Biological
Also called TIL, autologous, tumor-reactive, T-cell product
TBio-4101 is an autologous selected and expanded tumor infiltrating lymphocyte (TIL) product generated following ex vivo expansion of tumor reactive TIL population found in tumor harvest. After preparation with non-myeloablative lymphodepletion chemotherapy (cyclophosphamide and fludarabine) followed by low dose radiation,TBio-4101, and IL-2.
PembrolizumabDrug
Also called Keytruda
Pembrolizumab will be administered after TIL infusion and continue every 3-6 weeks for up to 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer | Experimental | Patients with locally advanced or metastatic breast cancer that has failed or is intolerant to standard of care therapies. Includes, HER2+, HER 2-, TNBC. Receives: Biological: TBio-4101; Drug: Pembrolizumab |
| Colorectal carcinoma | Experimental | Patients with advanced, metastatic colorectal adenocarcinoma who have failed or are intolerant to at least one line of therapy that included either irinotecan or oxaliplatin. Receives: Biological: TBio-4101; Drug: Pembrolizumab |
| Uveal Melanoma | Experimental | Patients with advanced, metastatic uveal melanoma. Receives: Biological: TBio-4101; Drug: Pembrolizumab |
| Cutaneous Melanoma | Experimental | Patients with cutaneous melanoma who have experienced disease progression following a PD-1 or PD-L1 inhibitor. Receives: Biological: TBio-4101; Drug: Pembrolizumab |
| Non-Small Cell Lung Cancer | Experimental | Patients with non-small cell lung cancer who have experienced disease progression following platinum containing chemotherapy and/or PD-1 or PD-L1 inhibitor. Receives: Biological: TBio-4101; Drug: Pembrolizumab |
| Head and Neck Squamous Cell Carcinoma | Experimental | * Patients with head and neck squamous cell carcinoma who have received no prior therapy for metastatic disease
* Patients with head and neck squamous cell carcinoma who are PD-1/PD-L1 inhibitor naïve at the time of TIL harvest and will be treated with TBio-4101 at the time of progression, inadequate response or intolerance to the PD-1/PD-L1 inhibitor-based standard of care regimen given on study. Receives: Biological: TBio-4101; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
The incidence of treatment-emergent adverse events will be tabulated using NCI CTCAE v5.0
Measured: 25 months
Secondary outcomes (3)
Proportion of patients with a response (ORR)
Percentage of all patients and within each cancer indication with a CR or PR as assessed by the independent central radiologist using RECIST 1.1 and iRECIST
Measured: 25 months
Estimated Disease Control Rate (DCR)
Portion of patient whose best response is a CR, PR, or stable disease (SD) as assessed by the independent central radiologist using RECIST v1.1 and iRECIST
Measured: 25 months
Estimated Duration of Response (DoR)
Duration of response, as measured in weeks, that patients with a CR or PR have no progressed (PD), as assessed by the independent central radiologist using RECIST v1.1 and iRECIST,
Measured: 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start17 Jan 2023
- Primary completion4 Feb 2025
- Study completion24 Feb 2025
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Patients enrolled into a Cohort based on malignancy.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turnstone Biologics, Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ines Verdon, MD, Study director, Turnstone Biologics, Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576077
- Sponsor's protocol ID
- TBio-4101-001
- Acronym
- STARLING
- Status last verified
- Mar 2025
- First submitted
- 7 Oct 2022
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of TBio-4101 (Autologous Selected and Expanded Tumor-Infiltrating Lymphocytes [TIL]) and Pembrolizumab in Patients With Advanced Solid Tumor Malignancies (STARLING)
- ClinicalTrials.gov ID
- NCT05576077
- Acronym / sponsor ID
- STARLING / TBio-4101-001
- Conditions
- Breast Cancer, Colorectal Cancer, Uveal Melanoma, Cutaneous Melanoma, Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
- Keywords
- MSS-CRC, TIL, Tumor infiltrating lymphocyte, TNBC, HR+ Breast, ER+ Breast, MSI-CRC, personalized medicine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Turnstone Biologics, Corp.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 4 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter trial to investigate TBio-4101, an autologous, neoantigen-selected, tumor-reactive TIL product, in patients with advanced solid malignancies.
Detailed description
This is a Phase 1 study to investigate TBio-4101. TBio-4101 is an autologous tumor infiltrating lymphocyte (TIL) therapy that utilizes tumor specific antigens to select, sort, and expand patient-specific tumor-reactive T-cells to be reinfused into the patient. The adoptive cell therapy is further enhanced through the use of non-myeloablative chemotherapy prior to TIL infusion, followed by the TIL plus IL-2 infusion. Low-dose radiation therapy is administered prior to and after TIL plus IL-2 infusion. Pembrolizumab is provided after the resolution of IL-2 toxicities. The trial is open to solid tumors of varying tumor mutational burdens.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Patients enrolled into a Cohort based on malignancy.
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer | Experimental | Biological: TBio-4101, Drug: PembrolizumabPatients with locally advanced or metastatic breast cancer that has failed or is intolerant to standard of care therapies. Includes, HER2+, HER 2-, TNBC. |
| Colorectal carcinoma | Experimental | Biological: TBio-4101, Drug: PembrolizumabPatients with advanced, metastatic colorectal adenocarcinoma who have failed or are intolerant to at least one line of therapy that included either irinotecan or oxaliplatin. |
| Uveal Melanoma | Experimental | Biological: TBio-4101, Drug: PembrolizumabPatients with advanced, metastatic uveal melanoma. |
| Cutaneous Melanoma | Experimental | Biological: TBio-4101, Drug: PembrolizumabPatients with cutaneous melanoma who have experienced disease progression following a PD-1 or PD-L1 inhibitor. |
| Non-Small Cell Lung Cancer | Experimental | Biological: TBio-4101, Drug: PembrolizumabPatients with non-small cell lung cancer who have experienced disease progression following platinum containing chemotherapy and/or PD-1 or PD-L1 inhibitor. |
| Head and Neck Squamous Cell Carcinoma | Experimental | Biological: TBio-4101, Drug: Pembrolizumab* Patients with head and neck squamous cell carcinoma who have received no prior therapy for metastatic disease * Patients with head and neck squamous cell carcinoma who are PD-1/PD-L1 inhibitor naïve at the time of TIL harvest and will be treated with TBio-4101 at the time of progression, inadequate response or intolerance to the PD-1/PD-L1 inhibitor-based standard of care regimen given on study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Advanced or metastatic breast carcinoma, colorectal adenocarcinoma, uveal melanoma, cutaneous melanoma, non-small cell lung cancer, or head and neck squamous cell carcinoma that has failed or is refractory to standard of care therapy
- Have at least one target lesion that can be used for response assessments and have at least 1 tumor amenable for tissue harvest for TIL manufacturing.
- ECOG performance status of 0 or 1
- Demonstrate adequate organ function
- Additional inclusion criteria exist
Key exclusion criteria (11 listed)
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy or any other form of immunosuppressive
- Currently infected with HIV Type 1 and Type 2, hepatitis B virus (HBV), hepatitis C virus (HCV), treponema pallidum (e.g., syphilis), West Nile virus (WNV), Human T-lymphotropic virus types 1 or II (HTLV I/II), or cytomegalovirus (CMV)
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable
- Serious cardiac condition, such as uncontrolled hypertension, concurrent congestive heart failure, prior history of Class III/IV cardiac disease (New York Heart Association [NYHA]), history of cardiac ischemia within the past 6 months, or prior history of cardiac arrhythmia requiring treatment. Patients who are > 60 years of age must undergo cardiology clearance exam and cardiac stress test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TBio-4101Also: TIL, autologous, tumor-reactive, T-cell productTBio-4101 is an autologous selected and expanded tumor infiltrating lymphocyte (TIL) product generated following ex vivo expansion of tumor reactive TIL population found in tumor harvest. After preparation with non-myeloablative lymphodepletion chemotherapy (cyclophosphamide and fludarabine) followed by low dose radiation,TBio-4101, and IL-2. | Biological | Breast Cancer, Colorectal carcinoma, Cutaneous Melanoma, Head and Neck Squamous Cell Carcinoma, Non-Small Cell Lung Cancer, Uveal Melanoma |
| PembrolizumabAlso: KeytrudaPembrolizumab will be administered after TIL infusion and continue every 3-6 weeks for up to 2 years. | Drug | Breast Cancer, Colorectal carcinoma, Cutaneous Melanoma, Head and Neck Squamous Cell Carcinoma, Non-Small Cell Lung Cancer, Uveal Melanoma |
Primary outcome
Safety and tolerability
Time frame: 25 months
The incidence of treatment-emergent adverse events will be tabulated using NCI CTCAE v5.0
3 secondary outcomes
Proportion of patients with a response (ORR)
Time frame: 25 months
Estimated Disease Control Rate (DCR)
Time frame: 25 months
Estimated Duration of Response (DoR)
Time frame: 25 months
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ines Verdon, MD study director
Turnstone Biologics, Corp.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TBio-4101 and Pembrolizumab in people with Breast Cancer and Colorectal Cancer, run by Turnstone Biologics, Corp. at 13 sites in 2 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 5 inclusion and 11 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 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, 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?
Safety and tolerability (time frame: 25 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2025.