Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
certepetide · 1 trial · 8 indications
The National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE) will be used to grade the intensity of adverse events throughout the study
| Arm | Type | Description |
|---|---|---|
| LSTA1 arm for Untreated Cholangiocarcinoma | EXPERIMENTAL | - |
| LSTA1 arm for Second-Line Cholangiocarcinoma | EXPERIMENTAL | - |
| Placebo arm for Untreated Cholangiocarcinoma | PLACEBO_COMPARATOR | - |
| Placebo arm for Second-Line Cholangiocarcinoma | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| certepetide | DRUG | LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given |
| Durvalumab | DRUG | 1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles |
| Cisplatin | DRUG | cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles |
| Gemcitabine | DRUG | gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles |
| FOLFOX regimen | DRUG | The following will be given every 14 days: * oxaliplatin 85 mg/m² and l-folinic acid 200 mg/m² or d,l-folinic acid 400 mg/m² concurrently, as a 2-hour IV infusion * fluorouracil (5-FU) 400 mg/m² will be given as an IV bolus over 5 minutes * fluorouracil (5-FU) 2400 mg/m² will be administered over 46 hours (via home-infusion pump) |
| Placebo | DRUG | Placebo given as a slow IV push over 1 minute when standard treatment(s) are given |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy ≥ 3 months * At least one measurable lesion as assessed by RECIST 1.1 * Adequate organ and marrow function * Adequate contraception * Patients with either of the following: * Pathologic...
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