Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gevokizumab · 1 trial · 3 indications
Log scale change of hs-CRP at Day 15 from baseline
DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the beginning of treatment with gevokizumab in combination with the SOC anti-cancer therapies and meets any of the protocol specified criteria.
DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the beginning of treatment with gevokizumab in combination with the SOC anti-cancer therapies and meets any of the protocol specified criteria.
PFS rate is defined as the percentage of participants who have not progressed or died due to any cause within a specified timeframe after study treatment initiation. Progression will be assessed per investigator assessment using RECIST v1.1.
PFS rate is defined as the percentage of participants who have not progressed or died due to any cause within a specified timeframe after study treatment initiation. Progression will be assessed per investigator assessment using RECIST v1.1.
PFS rate is defined as the percentage of participants who have not progressed or died due to any cause within a specified timeframe after study treatment initiation. Progression will be assessed per investigator assessment using RECIST v1.1.
| Arm | Type | Description |
|---|---|---|
| Cohort A: 1st line colorectal cancer | EXPERIMENTAL | Treatment for 1st line metastatic colorectal cancer (mCRC) with Gevokizumab, modified FOLFOX6, bevacizumab |
| Cohort B: 2nd line colorectal cancer | EXPERIMENTAL | Treatment for 2nd line mCRC with Gevokizumab, FOLFIRI, bevacizumab |
| Cohort C: 2nd line gastroesophageal cancer | EXPERIMENTAL | Treatment for 2nd line metastatic gastroesophageal cancer (mGEC) with Gevokizumab, paclitaxel, ramucirumab |
| Cohort D: 2nd or 3rd line renal cell carcinoma | EXPERIMENTAL | Treatment for 2nd or 3rd line metastatic renal cell carcinoma (mRCC) with Gevokizumab, cabozantinib |
| Name | Type | Description |
|---|---|---|
| Gevokizumab | DRUG | 60 mg/mL concentration; administered intravenously (IV) |
| Bevacizumab | DRUG | 25 mg/mL concentration; administered IV |
| Modified FOLFOX6 | DRUG | Oxaliplatin \[5 mg/mL concentration; administered IV\], leucovorin \[10 mg/mL concentration; administered IV\] (or levoleucovorin \[10 mg/mL concentration; administered IV\]), and 5-fluorouracil \[50 mg/mL concentration; administered IV\] |
| FOLFIRI | DRUG | Irinotecan \[20 mg/mL concentration; administered IV\], leucovorin \[10 mg/mL concentration; administered IV\] (or levoleucovorin \[10 mg/mL concentration; administered IV\]), and 5-fluorouracil \[50 mg/mL concentration; administered IV\] |
| Ramucirumab | DRUG | 10 mg/mL concentration; administered IV |
| Paclitaxel | DRUG | 6 mg/mL concentration; administered IV |
| Cabozantinib | DRUG | 60 mg tablet; administered orally |
Key Inclusion Criteria: For All Cohorts: * Adult ≥ 18 years old. * Metastatic disease not amenable to potentially curative surgery and with available archival tumor tissue or fresh tumor tissue biopsy. * Presence of at least 1 measurable lesion assessed by CT and/or MRI according to RECIST 1.1. * ...
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Gevokizumab is an investigational small molecule being studied for the treatment of colorectal cancer. It is also being evaluated in gastroesophageal cancer and renal cell carcinoma. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.
Gevokizumab is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in cancer patients.
Gevokizumab is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied for its potential use in treating colorectal cancer and other solid tumors.
Gevokizumab has been studied in one completed Phase 1 clinical trial with the identifier NCT03798626. This trial evaluated the drug in combination with standard of care anti-cancer therapies for metastatic colorectal, gastroesophageal, and renal cancers. The trial enrolled 167 participants across multiple countries.
Gevokizumab is a small molecule therapeutic agent. Its specific molecular target has not been disclosed in available information. The drug is being investigated for its potential anti-cancer activity in combination with standard treatments for colorectal cancer and other solid tumors.