Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as VPM087
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 monoclonal antibody being studied in oncology, specifically for colorectal cancer. It was evaluated in a Phase 1 trial in combination with standard of care anti-cancer therapies for metastatic colorectal, gastroesophageal, and renal cancers. It is not an approved treatment and remains in clinical development.
Gevokizumab targets IL1B, also known as interleukin-1 beta. It is classified as a negative allosteric modulator of that target. By binding IL1B, the antibody is designed to interfere with interleukin-1 beta signaling, a pathway that has been explored in the tumor microenvironment of solid tumors.
Gevokizumab is being developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor associated with the clinical program evaluating the antibody in metastatic colorectal, gastroesophageal, and renal cancers alongside standard of care anti-cancer therapies.
Gevokizumab is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 1 program has been completed, and no active trials are currently listed for this asset.
Gevokizumab was studied in the completed Phase 1 trial NCT03798626, titled Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers. That trial enrolled 167 participants across the United States, Australia, Belgium, Canada, Chile, Czechia, Germany, Israel, Italy, Japan, Singapore, South Korea, Spain, Taiwan, and the United Kingdom.