Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IMC-11F8 · 3 trials · 3 indications
CR and PR defined using Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and PR defined as a ≥30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence) / (total number of participants treated) \* 100.
Data presented are the number of participants who experienced 1 or more TEAEs or SAEs regardless of causality. An adverse event was considered as TEAE if it occurred any time after the administration of the first dose of study drug or up to 30 days after the last dose of study treatment or if it occurred prior to the first dose and worsened while on treatment. A summary of SAEs and other non-SAEs regardless of causality is located in the Reported Adverse Events module.
Cmax at steady state (after the last dose of the initial 6-week treatment cycle).
Cmin is defined as the minimum concentration the drug achieved after administration of first infusion and prior to the administration of second infusion.
Cmin was calculated prior to the last dose of the initial 6-week treatment cycle.
AUC(0-∞) was calculated only for participants in Cohort 2 as the percentage of AUC extrapolated beyond tlast was greater than 30% for all the remaining participants.
Steady state AUC(0-336) values are reported.
The t½ is defined as the time taken for study drug in blood to decrease to half of its concentration.
The t½ is defined as the time taken for study drug in blood to decrease to half of its concentration.
CL is defined as the volume of plasma that is cleared of study drug per unit time. CL was not analyzed for participants in Cohorts 1 and 3 as CL is derived from AUC(0-∞). AUC(0-∞) was calculated only for participants in Cohort 2 as the percentage of AUC extrapolated beyond tlast was greater than 30% for the remaining participants.
CL is defined as the volume of plasma that is cleared of study drug per unit time. Data did not allow calculation of CL for participants in Cohorts 1 and 3.
Vss is that amount of plasma in which the study drug needs to be dissolved to attain a steady state drug concentration. Vss was not analyzed for participants in Cohorts 1 and 3 as Vss is derived from AUC (0-∞). AUC(0-∞) was calculated only for participants in Cohort 2 as the percentage of AUC extrapolated beyond tlast was greater than 30% for the remaining participants.
Vss is that amount of plasma in which the study drug needs to be dissolved to attain a steady state drug concentration. Data did not allow calculation of Vss for participants in Cohorts 1 and 3.
| Arm | Type | Description |
|---|---|---|
| IMC-11F8 (necitumumab) /mFOLFOX-6 regimen | EXPERIMENTAL | Participants will receive IMC-11F8 (necitumumab) once every 2 weeks in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) |
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| Cohort 3 | EXPERIMENTAL | - |
| IMC-11F8 (Every week) | EXPERIMENTAL | Cycle of therapy administered intravenously, once a week for 6 weeks, for a total of six doses per cycle. |
| IMC-11F8 (Every other week) | EXPERIMENTAL | Cycle of therapy administered intravenously, every other week for 6 weeks, for a total of three doses per cycle. |
| Name | Type | Description |
|---|---|---|
| IMC-11F8 (necitumumab) | BIOLOGICAL | IMC-11F8 800 milligrams (mg) intravenous (IV) infusion over 50 minutes on Day 1 |
| Oxaliplatin | DRUG | Oxaliplatin 85 milligrams per meter square (mg/m²) IV infusion over 2 hours on Day 1 |
| Folinic acid (FA) | DRUG | FA 400 mg/m² IV infusion bolus injection |
| 5-FU | DRUG | 5-FU 400 mg/m² as a bolus followed by 2400 mg/m² IV continuous infusion over 46 hours |
| IMC-11F8 | BIOLOGICAL | 600 milligrams (mg) intravenously, Days 1 and 8 every 3 weeks |
| IMC-11F8 I.V. | BIOLOGICAL | Cohort 4 600 mg I.V. |
Inclusion Criteria: * Histologically-confirmed, EGFR-detectable or EGFR-undetectable CRC * Locally-advanced unresectable or metastatic adenocarcinoma of the colon or rectum * At least 1 unidimensional-measurable target lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI); tar...
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IMC-11F8 is an investigational monoclonal antibody being studied for the treatment of solid tumors, including metastatic colorectal cancer. It has been evaluated in clinical trials for patients with advanced solid tumors and colorectal cancer who have not responded to standard therapy.
IMC-11F8 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY.
IMC-11F8 has completed Phase 2 clinical trials for metastatic colorectal cancer. It remains an investigational drug and has not been approved by regulatory authorities for any use.
IMC-11F8 has been studied in three completed clinical trials. NCT00801177 was a Phase 1 study in patients with solid tumors in the Netherlands. NCT00835185 was a Phase 2 study in participants with metastatic colorectal cancer in Belgium and Spain. NCT01088464 was a Phase 1 study in participants with advanced solid tumors in Japan.
IMC-11F8 is also known by the name IMC-11F8, and no other alternative names have been reported for this investigational monoclonal antibody.