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A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors (STARLING)

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ClinicalTrials.gov Identifier: NCT05576077
Recruitment Status : Not yet recruiting
First Posted : October 12, 2022
Last Update Posted : October 13, 2022
Sponsor:
Information provided by (Responsible Party):
Turnstone Biologics, Corp.

Tracking Information
First Submitted Date  ICMJE October 7, 2022
First Posted Date  ICMJE October 12, 2022
Last Update Posted Date October 13, 2022
Estimated Study Start Date  ICMJE October 30, 2022
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2022)		 Safety and tolerability [ Time Frame: 25 months ]
The incidence of treatment-emergent adverse events will be tabulated using NCI CTCAE v5.0
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2022)
  • Proportion of patients with a response (ORR) [ Time Frame: 25 months ]
    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
  • Estimated Disease Control Rate (DCR) [ Time Frame: 25 months ]
    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
  • Estimated Duration of Response (DoR) [ Time Frame: 25 months ]
    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,
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors
Official Title  ICMJE 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)
Brief Summary 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. Pembrolizumab is provided after the resolution of IL-2 toxicities. The trial is open to solid tumors of varying tumor mutational burdens.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients enrolled into a Cohort based on malignancy.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Colorectal Cancer
  • Uveal Melanoma
Intervention  ICMJE
  • Biological: TBio-4101
    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 TBio-4101 and IL-2.
    Other Name: TIL, autologous, tumor-reactive, T-cell product
  • Drug: Pembrolizumab
    Pembrolizumab will be administered after TIL infusion and continue every 3 weeks for up to 2 years.
    Other Name: Keytruda
Study Arms  ICMJE
  • Experimental: Breast Cancer
    Patients with locally advanced or metastatic breast cancer that has failed or is intolerant to standard of care therapies. Includes, HER2+, HER 2-, TNBC.
    Interventions:
    • Biological: TBio-4101
    • Drug: Pembrolizumab
  • Experimental: Colorectal carcinoma
    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.
    Interventions:
    • Biological: TBio-4101
    • Drug: Pembrolizumab
  • Experimental: Uveal Melanoma
    Patients with advanced, metastatic uveal melanoma.
    Interventions:
    • Biological: TBio-4101
    • Drug: Pembrolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 7, 2022)		 30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2024
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Advanced or metastatic breast carcinoma, colorectal adenocarcinoma, or uveal melanoma 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:

  • Ischemic heart disease (current or past), or clinically significant atrial or ventricular rhythm abnormality are excluded unless cardiac clearance is received.
  • Prior cell therapy or organ transplant
  • Have a primary or acquired immunodeficiency disorders
  • History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, IL-2, or pembrolizumab, or any of their constituents
  • LVEF ≤ 45% or NYHA functional classification > 1
  • FEV1 ≤ 60% of predicted value and DLCO (corrected) < 60% of predicted value
  • Brain metastasis
  • Chronic anti-coagulant therapy that cannot either be discontinued or temporarily changed
  • Additional exclusion criteria exist
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Saundra Kirven 919- 451-4752 skirven@oncobay.com
Contact: Huguette Graham ClinicalOps@turnstonebio.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05576077
Other Study ID Numbers  ICMJE TBio-4101-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Turnstone Biologics, Corp.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Turnstone Biologics, Corp.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ines Verdon, MD Turnstone Biologics, Corp.
PRS Account Turnstone Biologics, Corp.
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP