Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TRB191 · 1 trial · 1 indication
Number of participants with AEs and SAEs, including changes in laboratory values, vital signs and echocardiograms (ECGs) qualifying and reported as AEs.
Number of participants with DLTs. A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher, unless clearly and incontrovertibly assessed as due to underlying disease, disease progression, or intercurrent illness, that occurs within the first 21 days of treatment with TRB191. Other clinically significant toxicities may be considered DLTs, even if not CTCAE grade 3 or higher.
Number of participants with dose adjustments (interruptions and reductions as a measure of tolerability.
Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure.
| Arm | Type | Description |
|---|---|---|
| TRB191 single agent | EXPERIMENTAL | Treatment with TRB191 single agent in patients with extensive-stage small cell lung cancer. |
| Name | Type | Description |
|---|---|---|
| TRB191 | DRUG | Subcutaneous injection of TRB191 |
Inclusion Criteria: * Age ≥ 18 years old * Histologically or cytologically confirmed and documented ES-SCLC * Dose escalation: Patients with ES-SCLC and disease progression after one or more chemotherapy regimens (with or without PD-L1 inhibitor) according to the local standard of care (SOC). Prior...