Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BT8009 · 1 trial · 8 indications
Safety reported as incidence of treatment-emergent adverse events using CTCAE v5.0 criteria.
Number of patients who experience dose limiting toxicities BT8009 when given as a monotherapy or in combination with pembrolizumab.
Proportion of participants with confirmed complete response or partial response to BT8009 as a monotherapy or in combination with pembrolizumab according to RECIST 1.1 criteria.
Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone.
Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone
Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone.
Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone.
Number of participants with advanced solid tumor malignancies associated with Nectin-4 expression receiving an alternative dose regimen of BT8009 as a monotherapy who experience treatment-emergent adverse events using CTCAE v5.0 criteria.
| Arm | Type | Description |
|---|---|---|
| Part A-1 -BT8009 Monotherapy Dose Escalation | EXPERIMENTAL | Participants will receive escalating doses of BT8009. |
| Part A-2 -BT8009 in Combination with Pembrolizumab Dose De-Escalation | EXPERIMENTAL | Participants will receive BT8009 and a standard dose of pembrolizumab. |
| Cohort B-1 - BT8009 Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive a selected dose of BT8009. |
| Cohort B-2- BT8009 Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive a selected dose of BT8009. |
| Cohort B-3- BT8009 Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive a selected dose of BT8009. . |
| Cohort B-4- BT8009 Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive a selected dose of BT8009. |
| Cohort B-5- BT8009 Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive a selected dose of BT8009. |
| Cohort B-6- BT8009 Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive a selected dose of BT8009. |
| Cohort B-7- BT8009 in Combination with Pembrolizumab Dose Expansion | EXPERIMENTAL | Participants will receive a selected dose of BT8009 and standard dose of pembrolizumab. |
| Part C - Renal Insufficiency BT8009 Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive a selected dose of BT8009. |
| Part D - BT8009 Monotherapy Supplementary PK | EXPERIMENTAL | Participants will receive a selected dose of BT8009. |
| Part B-8 - BT8009 Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive a selected dose of BT8009. |
| Part B-9 - BT8009 Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive a selected dose of BT8009. |
| Name | Type | Description |
|---|---|---|
| BT8009 | DRUG | Bicyclic Toxin Conjugate (BTC) administered either weekly (i.e., on Days 1, 8, 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle for participants in A-1. Participants in Cohorts A-2 and B-7 will receive BT8009 weekly on 21-day cycle. Participants in Parts B-1-B-6 will receive BT8009 weekly either on a 21-day or 28-day cycle. Participants in Parts B-8 and B-9 will receive BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive BT8009 once weekly (i.e., on Days 1, 8, 15, and 22) on a 28-day cycle. Participants in Part D will receive BT8009 once weekly on a 28-day cycle. |
| Pembrolizumab | DRUG | Participants in Cohorts A-2 and B-7 will receive 200 mg IV over 30-minute infusion of pembrolizumab on Day 1 of each Q3W. |
Key Inclusion Criteria * Life expectancy ≥12 weeks. * Patients must have measurable disease per RECIST 1.1. * Part A-1 cohorts: * Must have exhausted all standard treatment options, including appropriate targeted therapies; or patients for which no standard therapy is considered appropriate * Patie...
BT8009 is an investigational small molecule being studied for the treatment of urinary bladder neoplasm, also known as bladder cancer. It is currently in Phase 1 clinical development for this indication.
BT8009 targets Nectin-4, a tumor antigen. It is designed to bind to Nectin-4, which is expressed on the surface of certain cancer cells, as part of its mechanism of action in treating advanced malignancies.
BT8009 is being developed by Bicycle Therapeutics plc, a biopharmaceutical company. The company's stock is traded under the ticker symbol BCYC.
BT8009 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being evaluated in an active Phase 1 clinical trial.
BT8009 is being studied in a Phase 1 clinical trial with the identifier NCT04561362. This trial, titled 'Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies,' is active but not recruiting participants and has an enrollment of 329.
BT8009 is not known by any alternative names. It is a distinct investigational compound developed by Bicycle Therapeutics for the treatment of Nectin-4 expressing cancers, including bladder cancer.