Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LB-100 · 2 trials · 4 indications
Number of patients with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events v5.0 (CTCAE v5.0)
Best overall response rate of the patients to the study treatment as assessed by International Working Group (IWG) 2006 criteria
| Arm | Type | Description |
|---|---|---|
| LB-100 for Intravenous administration | EXPERIMENTAL | Phase Ib: Escalating doses of LB-100 administered. Phase 2: Safe dose of LB-100 from phase Ib administered. |
| LB-100 for Injection and Docetaxel | EXPERIMENTAL | Part 1: LB-100 infusion. Part 2: LB-100 infusion and docetaxel infusion. |
| Name | Type | Description |
|---|---|---|
| LB-100 | DRUG | Phase Ib: Two escalating doses of LB-100 in two separate cohorts will be administered intravenously on days 1, 3 and 5 of a 21-day cycle over 120 minutes. Phase 2: Safe dose of LB-100 as determined from phase Ib will be administered intravenously on days 1, 3 and 5 of a 21-day cycle over 120 minutes. |
| LB-100 for Injection | DRUG | Part 1 and Part 2: LB-100 for Injection infusion on Days 1,2,3 of each 21 day cycle. |
| Docetaxel | DRUG | Part 2: Docetaxel infusion on Day 2 of each 21 day cycle. |
Inclusion Criteria: 1. Patient has signed the Informed Consent Form (ICF) and is able to comply with protocol requirements. 2. Patient has adequate organ function as defined by the following laboratory values: * Creatinine clearance (CrCl) ≥ 60ml/min * Total serum bilirubin \< 1.5 x Upper Li...
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