Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BT1718 · 1 trial · 4 indications
Determine a dose at which no more than one out of six patients at the same dose level experiences a probable or highly probable BT1718-related dose limiting toxicity (DLT).
Determine the frequency and causality of each adverse event (AE) to BT1718 and grade severity according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.02.
| Arm | Type | Description |
|---|---|---|
| Dose escalation phase | EXPERIMENTAL | Groups of patients will receive increasing doses of BT1718 to find a safe dose that best targets the cancer cells. In this phase it is expected that approximately 50-60 patients with advanced solid tumours will be entered in the study. |
| Dose expansion phase | EXPERIMENTAL | Larger groups of patients will receive the selected dose of BT1718 to allow us to find out more about how the drug is working. In this phase it is proposed that up to 70 patients with tumour types known to commonly overexpress MT1-MMP and where MT1-MMP overexpression is confirmed during prospective and retrospective (in appropriate patients) selection at enrolment (i.e. squamous non-small cell lung cancer) will be entered in the study. |
| Name | Type | Description |
|---|---|---|
| BT1718 | DRUG | Dose escalation will consist of Stage 1 and 2. Stage 1 patients will receive BT1718 intravenously twice a week (D: 1,4,8,11,15,18) for 3 out of 4 weeks. Starting dose will be 0.6mg/m2. Single patient cohorts will be explored, but it will change to 3 to 6 patients cohorts. Stage 2 patients will receive BT1718 intravenously once a week (D: 1,8,15) for 3 out of 4 weeks. This stage will have 3 to 6 patient cohorts until the recommended dose is established. The expansion phase will consist of two or more expansion cohorts to include tumour types known to commonly over-express MT1-MMP and where MT1-MMP overexpression is confirmed during prospective and retrospective (in appropriate patients) selection at enrolment. A squamous NSCLC and basket cohort will include approximately 16 patients each with high MT1-MMP levels. In the expansion cohorts BT1718 will be administered intravenously at the once weekly RP2D established in Phase I, Stage 2. |
Inclusion Criteria: 1. Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up 2. Phase I, dose escalation phase (Stages 1 and 2): • Histologically or cytologically proven advanced solid tumour, refractory to conventional treatment, or for which n...
| 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 |
BT1718 is an investigational small molecule being developed for the treatment of advanced solid tumours, including non-small cell lung cancer, non-small cell lung sarcoma, and oesophageal cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
BT1718 is being developed by Bicycle Therapeutics plc, a biopharmaceutical company listed on the stock exchange under the ticker symbol BCYC. The company is conducting clinical trials to evaluate the safety and efficacy of BT1718 in patients with advanced solid tumours.
BT1718 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not received regulatory approval and is still undergoing clinical evaluation for the treatment of advanced solid tumours.
BT1718 has been studied in a Phase 1 clinical trial with the identifier NCT03486730, titled 'BT1718 in Patients with Advanced Solid Tumours.' This trial enrolled 72 participants and was conducted in the United Kingdom. The trial has been completed.
No alternative names for BT1718 have been reported. It is identified solely by its investigational name, BT1718, and is being developed by Bicycle Therapeutics plc for the treatment of advanced solid tumours.