Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BT7480 · 1 trial · 1 indication
Incidence and severity of treatment emergent adverse events to assess safety and tolerability following treatment with BT7480 alone and in patients with renal insufficiency using NCI CTCAE v5.0 criteria
Overall response rate (ORR) following treatment with BT7480 alone and in combination with nivolumab according to RECIST 1.1 criteria nivolumab according to RECIST 1.1 criteria
Clinical benefit rate (CBR) following treatment with BT7480 alone and in combination with nivolumab according to RECIST 1.1 criteria nivolumab according to RECIST 1.1 criteria
| Arm | Type | Description |
|---|---|---|
| BT7480 monotherapy dose escalation | EXPERIMENTAL | Participants will receive increasing doses of BT7480. It is expected that approximately 80 patients will participate in this dose escalation arm. |
| BT7480 and nivolumab dose escalation | EXPERIMENTAL | Participants will receive increasing doses of BT7480 and standard dose of nivolumab. It is expected that approximately 12 patients will participate in this dose escalation arm. |
| BT7480 monotherapy dose expansion | EXPERIMENTAL | Participants will receive a selected dose of BT7480. It is expected that approximately 45 patients will participate in this dose expansion arm in Phase 2. |
| BT7480 and nivolumab dose expansion | EXPERIMENTAL | Participants will receive a selected dose of BT7480 and standard dose of nivolumab. It is expected that approximately 45 patients will participate in this dose expansion arm in Phase 2. |
| BT7480 monotherapy in patients with renal insufficiency | EXPERIMENTAL | Participants will receive a selected dose of BT7480. It is expected that approximately 12 patients will participate in this dose confirmation arm. |
| Name | Type | Description |
|---|---|---|
| BT7480 | DRUG | Participants will receive a 60 minute IV infusion of BT7480 once weekly (i.e., on Days 1,8,15 and 22) during a 28-day cycle |
| Nivolumab | DRUG | Nivolumab will be given as a 240mg dose every 2 weeks administered as per local labelling as a 30 minute IV infusion |
Inclusion Criteria: * Must have locally advanced or metastatic disease that is refractory to standard therapy, or for which no standard therapy is judged to be appropriate or provide clinical benefit, as judged by the Investigator * Must have a histologically or cytologically confirmed malignant so...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
BT7480 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently being studied in a Phase 1 clinical trial in patients with advanced malignancies associated with Nectin-4 expression. The drug is not yet approved and remains in clinical development.
BT7480 targets Nectin-4, a protein expressed on the surface of certain tumor cells. By targeting Nectin-4, the drug is designed to interact with cancer cells that express this protein. This mechanism is being evaluated in a Phase 1 trial for advanced solid tumors.
BT7480 is being developed by Bicycle Therapeutics plc, a biopharmaceutical company listed on the stock exchange under the ticker symbol BCYC. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with advanced solid tumors.
BT7480 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting participants, though enrollment is currently not open, and the study is classified as active but not recruiting.
BT7480 is being evaluated in a single Phase 1 clinical trial with the identifier NCT05163041. This study, titled 'Study BT7480-100 in Patients With Advanced Malignancies Associated With Nectin-4 Expression,' is enrolling approximately 200 participants aged 18 years and older in the United States and United Kingdom.