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NCT05576077: STARLING
A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors
Terminated
Phase 1
Last updated 10 March 2025
What this trial tests
Phase 1 trial testing TBio-4101 in Breast Cancer in 31 participants. Terminated before completion.
Timeline
17 January 2023
Primary endpoint
4 February 2025
4 February 2025
24 February 2025
Quick facts
| Lead sponsor | Turnstone Biologics, Corp. |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 31 |
| Start date | 17 January 2023 |
| Primary completion | 4 February 2025 |
| Estimated completion | 24 February 2025 |
| Sites | 13 locations across Canada, United States |
Drugs / interventions tested
- TBio-4101 — full drug profile →
- Pembrolizumab (pembrolizumab) — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Colorectal Cancer — all drugs for Colorectal Cancer →
- Uveal Melanoma — all drugs for Uveal Melanoma →
- Cutaneous Melanoma — all drugs for Cutaneous Melanoma →
Sponsor
Turnstone Biologics, Corp. — full company profile →
Who can join
Adults 18 to 70, any sex, with Breast Cancer or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A multicenter trial to investigate TBio-4101, an autologous, neoantigen-selected, tumor-reactive TIL product, in patients with advanced solid malignancies.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Current and future immunotherapy for breast cancer.
Heater NK, Warrior S, Lu J. · · 2024 · cited 38× · PMID 39722028 · DOI 10.1186/s13045-024-01649-z -
Recent clinical researches and technological development in TIL therapy.
Matsueda S, Chen L, Li H, Yao H, et al · · 2024 · cited 23× · PMID 39264449 · DOI 10.1007/s00262-024-03793-4 -
Current and Future Trends of Colorectal Cancer Treatment: Exploring Advances in Immunotherapy.
Nikolouzakis TK, Chrysos E, Docea AO, Fragkiadaki P, et al · · 2024 · cited 20× · PMID 38893120 · DOI 10.3390/cancers16111995 -
Recent advances and remaining challenges in lung cancer therapy.
Barr T, Ma S, Li Z, Yu J. · · 2024 · cited 20× · PMID 38321811 · DOI 10.1097/cm9.0000000000002991 -
Personalised neoantigen-based therapy in colorectal cancer.
Zhu YJ, Li X, Chen TT, Wang JX, et al · · 2023 · cited 20× · PMID 37921274 · DOI 10.1002/ctm2.1461 -
Cellular Therapy for Lung Cancer: Focusing on Chimeric Antigen Receptor T (CAR T) Cells and Tumor-Infiltrating Lymphocyte (TIL) Therapy.
Katiyar V, Chesney J, Kloecker G. · · 2023 · cited 19× · PMID 37509394 · DOI 10.3390/cancers15143733 -
Immunotherapies against HER2-Positive Breast Cancer.
Duro-Sánchez S, Alonso MR, Arribas J. · · 2023 · cited 18× · PMID 36831412 · DOI 10.3390/cancers15041069 -
The role of neoantigens and tumor mutational burden in cancer immunotherapy: advances, mechanisms, and perspectives.
Sun S, Liu L, Zhang J, Sun L, et al · · 2025 · cited 17× · PMID 40898324 · DOI 10.1186/s13045-025-01732-z
Verify or expand the search:
- PubMed search for NCT05576077
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of TBio-4101
Trials testing the same drug.
- NCT05628883 — Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma · Phase 1 · completed
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
- NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
- NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
- NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
- NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
- NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
Other Turnstone Biologics, Corp. trials
Trials by the same sponsor.
- NCT04301011 — Study of TBio-6517 Given Alone or in Combination With Pembrolizumab in Solid Tumors · Phase 1 · terminated
- NCT03773744 — MG1-MAGEA3 With Ad-MAGEA3 and Pembrolizumab in Patients With Previously Treated Metastatic Melanoma or Cutaneous Squamou · Phase 1 · withdrawn
- NCT03618953 — This is a Trial of MG1-E6E7 With Ad-E6E7 and Atezolizumab in Patients With HPV Associated Cancers · Phase 1 · terminated
- NCT02879760 — Oncolytic MG1-MAGEA3 With Ad-MAGEA3 Vaccine in Combination With Pembrolizumab for Non-Small Cell Lung Cancer Patients · Phase 1, PHASE2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT05576077 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Turnstone Biologics, Corp.
- Last refreshed: 10 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05576077.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing