Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BT5528 · 1 trial · 7 indications
Safety reported as incidence of treatment-emergent adverse events
Maximum Tolerated Dose (MTD)
Objective Response Rate (ORR)
Duration of Response (DOR)
Clinical benefit rate
Time to Progression (TTP)
Progression free survival (PFS)
Progression free survival (PFS)
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| Arm | Type | Description |
|---|---|---|
| Phase I - Dose escalation (BT5528) | EXPERIMENTAL | Cohorts of participants will receive increasing doses of BT5528. It is expected that up to 72 participants will participate in this dose escalation arm. |
| Phase I - Dose escalation combination (BT5528 & nivolumab) | EXPERIMENTAL | Cohorts of participants will receive increasing doses of BT5528 and a standard dose of nivolumab. It is expected that up to 24 participants will participate in this dose-escalation combination arm. |
| Phase II - Dose expansion 1 (BT5528) | EXPERIMENTAL | A cohort of participants will receive the selected dose of BT5528 as a monotherapy. It is expected that up to 164 patients have solid tumors (Cohort 1: urothelial cancers, Cohort 2: ovarian cancer, Cohort 3: non-small cell lung cancer, Cohort 4: head and neck cancer, Cohort 5: triple-negative breast cancer, and Cohort 6: gastric/upper gastrointestinal cancer) historically known for high expression of EphA2 will participate in this dose-expansion arm, Cohort 7: urothelial MMAE exposed, Cohort 8: head and neck squamous cell carcinoma |
| Name | Type | Description |
|---|---|---|
| BT5528 | DRUG | Participants will receive a 60-minute intravenous infusion of BT5528 once a week (Days 1, 8, 15, and 22) or every other week (Days 1 and 15) on a 4-week cycle at the selected dose. |
| Nivolumab | DRUG | Participants will receive nivolumab at 480mg intravenous infusion every 4 weeks. |
General Inclusion: * Written informed consent, according to local guidelines, signed and dated by the patient or by a legal guardian prior to the performance of any study-specific procedures, sampling or analyses * At least 18 years-of-age at the time of signature of the informed consent form * Eas...
BT5528 is an investigational small molecule being developed for the treatment of advanced solid tumors historically known for high EphA2 expression, including urothelial cancer, ovarian cancer, non-small cell lung cancer, head and neck cancer, triple negative breast cancer, and gastric/upper gastrointestinal cancer.
BT5528 targets EphA2, a receptor tyrosine kinase that is overexpressed in certain solid tumors. By binding to EphA2, BT5528 is designed to deliver a cytotoxic payload specifically to cancer cells that express this target, potentially reducing damage to healthy tissues.
BT5528 is being developed by Bicycle Therapeutics plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol BCYC. The company is conducting clinical trials to evaluate the safety and efficacy of BT5528 in patients with advanced solid tumors.
BT5528 is currently 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 enrolling participants, though recruitment is not yet complete.
BT5528 is being studied in a single Phase 1 clinical trial with the identifier NCT04180371. This trial, titled 'Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression,' is enrolling approximately 288 participants across the United States, Belgium, South Korea, Spain, and the United Kingdom.
BT5528 is the sole name provided for this investigational agent. No alternative names or aliases have been reported for this drug in the available clinical trial information.