Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03798626 | Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers | PHASE1 | COMPLETED | 167 | — | — | May 22, 2019 | Feb 5, 2025 | Apr 1, 2026 | 34 | United States, Australia +13 |
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. * ...