Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TBio-4101 · 2 trials · 12 indications
Percentage of participants who undergo tumor resection that successfully receive TBio-4101
The incidence of treatment-emergent adverse events will be tabulated using NCI CTCAE v5.0
| Arm | Type | Description |
|---|---|---|
| Infusion of TBio-4101 TIL | EXPERIMENTAL | TBio-4101 is a tumor-infiltrating lymphocyte (TIL) product: participants tumor tissue is surgically removed and immune T-cells are taken out of the tumor and multiplied, or grown, in the laboratory. TIL product infused intravenously over 20 to 30 minutes within 2 to 4 days after the last dose of fludarabine Participants will also receive: * Cyclophosphamide dose 60 mg/kg/day for 2 days administered IV in 250 mL dextrose 5% in water infused simultaneously with Mesna 15 mg/kg/day delivered over 1 hour per day for 2 days. Fludarabine 25 mg/m2/day is delivered by intravenous piggyback daily over 15-30 minutes for 5 days. * Interleukin-2 (IL-2)- will be given to participants through IV after they receive the infusion of the TIL. IL-2 is administered at a dose of 600,000 IU/kg (based on actual body weight) IV every 8-12 hours beginning within 24 hours of TIL infusion for a maximum of 6 doses. |
| TIL Harvest/Standard of care Treatment Phase | OTHER | Participants will undergo tumor harvest for TIL and then receive 2 to 3 cycles of pembrolizumab or pembrolizumab/platinum chemotherapy (cisplatin or carboplatin / 5-FU) as per standard of care. |
| TBio-4101 Treatment | EXPERIMENTAL | Participants without radiographic response (progressive disease) after pembrolizumab or pembrolizumab/platinum chemotherapy, and who meet eligibility requirements, will transition to receive TBio-4101. Participants will receive TBio-4101 infusion and after completion of TBio-4101 infusion, IL-2 will be administered every 8 hours, for up to 6 doses. Finally, pembrolizumab will be administered on Day 14, Day 35, and Day 56 and Q6W (beginning Week 12) thereafter for up to 2 years until discontinuation. |
| Name | Type | Description |
|---|---|---|
| TBio-4101 | BIOLOGICAL | TBio-4101 is a tumor-infiltrating lymphocyte (TIL) product that involves the use of special immune cells called T-cells. A T-cell is a type of lymphocyte, or white blood cell. |
| Cyclophosphamide | DRUG | Participants will receive Cyclophosphamide 60 mg/kg/day intravenously (IV) in 250 mL over approximately 1 hour per day for 2 days. |
| Fludarabine | DRUG | Participants will receive an intravenously (IV) infusion of Fludarabine 25 mg/m2 for approximately 15 to 30 minutes for 5 days, prior to T-Cell infusion |
| Interleukin-2 | DRUG | Participants will receive Interleukin-2 (IL-2) 600 000 IU/kg intravenously every 8 to 12 hours beginning within 24 hours after T-cell infusion. |
| Pembrolizumab | DRUG | Will be administered as per standard of care. Participants with initial partial or complete radiographic response will continue on the same therapy at the discretion of the treating physician. |
| Platinum based chemotherapy | DRUG | Will be administered as per standard of care. Participants with initial partial or complete radiographic response will continue on the same therapy at the discretion of the treating physician. |
| Aldesleukin | DRUG | After completion of TBio-4101 infusion, Aldesleukin will be administered every 8 hours, for up to 6 doses. |
Inclusion Criteria: * Participants must have histologically confirmed, unresectable or metastatic melanoma as follows: * Cutaneous, non-acral, melanoma (including melanoma of unknown primary) * Cutaneous acral melanoma * Mucosal melanoma * Ocular melanoma (including uveal, iris, conjunctiv...
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TBio-4101 is an investigational monoclonal antibody being studied for the treatment of squamous cell carcinoma of the head and neck and metastatic melanoma. It is currently in Phase 1 clinical trials for these oncology indications.
TBio-4101 is a monoclonal antibody, a type of targeted therapy designed to interact with specific proteins involved in cancer. The precise molecular target of TBio-4101 has not been disclosed in available information.
TBio-4101 is being developed by Turnstone Biologics Corp., a biopharmaceutical company. The company's stock is traded under the ticker symbol TSBX.
TBio-4101 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials are listed, one completed and one active but not recruiting.
TBio-4101 is being studied in two Phase 1 trials. NCT05628883, a completed proof-of-concept study in relapsed or refractory melanoma, enrolled 17 participants. NCT06236425, an active trial in recurrent or metastatic head and neck squamous cell carcinoma, has enrolled 7 participants.
TBio-4101 is a distinct investigational monoclonal antibody developed by Turnstone Biologics. No alternative names for this drug have been reported in the available clinical trial information.