Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BI-1808 · 1 trial · 4 indications
AEs will be assessed by the investigators by severity and will be graded according to the NCI CTCAE v5.0 or higher and causality between AEs and the exposure to the study treatment.
Determine the hypothesized RP2D dose for BI-1808 Phase 2a according to mTPI-2 design
SAEs will be assessed by the investigators by severity and will be graded according to the NCI CTCAE v5.0 or higher and causality between SAEs and the exposure to the study treatment
Select the RP2D dose for BI-1808 derived from the totality of PK, PD, clinical response, safety,and tolerability observed in signal seeking and dose optimization cohorts.
| Arm | Type | Description |
|---|---|---|
| Phase I, Part A - Dose escalation and safety of BI-1808 as single agent | EXPERIMENTAL | Dose escalation of BI-1808 administrated a single agent |
| Phase I, Part B - Dose escalation and Safety of BI-1808 in combination with pembrolizumab | EXPERIMENTAL | Dose escalation of BI-1808 in combination with pembrolizumab. |
| Phase 2a - Part A dose expansion of BI-1808 as a single agent | EXPERIMENTAL | BI-1808 administered as a single agent at the hypothesized recommended phase 2 dose determined in Phase 1 |
| Phase 2a, Part B - Dose expansion of BI-1808 in combination with pembrolizumab | EXPERIMENTAL | BI-1808 administered in combination with pembrolizumab at the respective hypothesized recommended phase 2 doses determined in Phase 1 |
| Phase 2a, Part C - Dose expansion of BI-1808 in combination with pembrolizumab and paclitaxel | EXPERIMENTAL | BI-1808 administered in combination with pembrolizumab and paclitaxel at the respective hypothesized recommended phase 2 doses determined in Phase 1. |
| Name | Type | Description |
|---|---|---|
| BI-1808 | DRUG | BI-1808 administered as a flat-dose IV infusion once every 3 weeks |
| Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection | DRUG | Pembrolizumab administered as a flat-dose IV infusion once every 3 weeks. |
| Paclitaxel 80 mg/m2 weekly | DRUG | Paclitaxel administered as a flat-dose IV infusion weekly. |
Inclusion Criteria: * Able and willing to provide written informed consent. * Aged 18 years or older. * Histologically confirmed advanced or metastatic malignancy eligible for an enrolling study cohort. * Disease progression following, intolerance of, ineligibility for, or refusal of applicable sta...