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NCT05576077 (TBio-4101 Pembrolizumab in Advanced Solid Tumors): BVCT ex-ante prediction vs. reported outcome

On 23 Apr 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 14 Aug 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant yet weak and commercially insufficient.

Clinical Trial

NCTID
NCT05576077
Acronym
STARLING
Drug Name
TBio-4101 Pembrolizumab
Drug MoA
autologous TIL cell therapy
Drug Modality
cell therapy
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Advanced Solid Tumors
Human Patients
60
Sponsor
Turnstone Biologics
Phase
Phase 1

Prediction of , index 1560

Prospective Prediction
Prediction Index
1560
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in OS)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit in ORR)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
113 days in advance
Readout Data Interpretation
25% ORR achieved by TBio-4101 + pembrolizumab for MSI-stable CRC vs 30%-40% ORR achieved by regorafenib+ nivolumab (Fakih et al. Huyck 2023 eClinicalMedicine).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant yet weak and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

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)
Phase
Phase 1
Status
Terminated
Enrollment
31
Lead sponsor
Turnstone Biologics, Corp.
Conditions
Breast Cancer; Colorectal Cancer; Uveal Melanoma; Cutaneous Melanoma; Non-Small Cell Lung Cancer; Head and Neck Squamous Cell Carcinoma
Interventions
BIOLOGICAL: TBio-4101; DRUG: Pembrolizumab
Design
Non randomized · Parallel · None
Primary purpose
Treatment
Start
2023-01-17
Primary completion
2025-02-04
Completion
2025-02-24
Primary outcomes
  • Safety and tolerability (25 months)

NCT05576077 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials