Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMT-676 · 1 trial · 1 indication
Type, incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Maximum Tolerated Dose will be determined by DLTs
Incidence of dose limiting toxicities
Overall response rate
Progression-free survival
| Arm | Type | Description |
|---|---|---|
| AMT-676(dose level 1)+5-FU+Leucovorin+Bevacizumab or Cetuximab(if applicable) | EXPERIMENTAL | - |
| AMT-676(dose level 2)+5-FU+Leucovorin+Bevacizumab or Cetuximab(if applicable) | EXPERIMENTAL | - |
| oxaliplatin/irinotecan+5-FU+ leucovorin +bevacizumab (or cetuximab) | EXPERIMENTAL | - |
| AMT-676+5-FU+Leucovorin+Bevacizumab or Cetuximab(if applicable)+Oxaliplatin | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AMT-676 | DRUG | Patients will get different dose levels treatment of AMT-676. AMT-676 will be Administered as an intravenous (IV) infusion every 2 weeks (Q2W) . |
| 5-FU | DRUG | 5-FU 400 mg/m\^2 IV bolus on day 1, followed by 1200 mg/m\^2/day x 2 days (total 2400 mg/m\^2 over 46-48 hours) IV continuous infusion, q2w |
| Leucovorin | DRUG | Leucovorin 400 mg/m\^2 IV day 1, q2w |
| Bevacizumab | DRUG | Bevacizumab 5 mg/kg IV, day 1 |
| Cetuximab | DRUG | Cetuximab 500 mg/m\^2 IV over 2 hours, day 1, q2w |
| Irinotecan | DRUG | Irinotecan 180 mg/m\^2 IV, day 1 |
| Oxaliplatin | DRUG | Oxaliplatin 85 mg/m\^2 IV, day 1 |
Inclusion Criteria: * Patients must be willing and able to sign the ICF, and to adhere to the study visit schedule and other protocol requirements * Patients with pathologically confirmed, unresectable advanced colorectal adenocarcinoma * Patients must have at least one measurable lesion as per REC...
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