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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
BT1718 is an investigational small molecule developed for the treatment of advanced solid tumours, including non-small cell lung cancer, non-small cell lung sarcoma, and oesophageal cancer. It is being studied in patients with these advanced cancers and has not been approved for commercial use.
BT1718 targets MT1-MMP, a membrane-bound matrix metalloproteinase that is overexpressed in many solid tumours. By binding to MT1-MMP, BT1718 is designed to deliver a cytotoxic payload selectively to tumour cells, potentially reducing damage to healthy tissue.
BT1718 is being developed by Bicycle Therapeutics plc, a biotechnology company listed on the Nasdaq under the ticker BCYC. The company is advancing BT1718 as part of its pipeline of targeted oncology therapies.
BT1718 is in Phase 1 clinical development. It is an investigational agent and has not received FDA approval. The Phase 1 trial has been completed, and further development steps have not been announced.
BT1718 has been evaluated in a single Phase 1 clinical trial, NCT03486730, titled "BT1718 in Patients with Advanced Solid Tumours." The trial enrolled 72 patients in the United Kingdom and has been completed. It included patients with advanced solid tumours, non-small cell lung cancer, non-small cell lung sarcoma, and oesophageal cancer.