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Gevokizumab

Phase 1

Colorectal Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Apr 1, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment167

FDA Designations

No designations recorded

Clinical trial landscape

Gevokizumab · 1 trial · 3 indications

Phase 1 1
NCT03798626Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal CancersColorectal Cancer
COMPLETED167 Analytics
PHASE1COMPLETED
Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1a/b (Cohorts A and B): Change in high-sensitivity C-reactive protein (hs-CRP) after first dose of gevokizumab monotherapy
Baseline, Day 15

Log scale change of hs-CRP at Day 15 from baseline

Part 1b (Safety run-in): Number of dose limiting toxicities (DLTs) [Cohort C and Cohort D]
First 4 weeks of combination treatment

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.

Part 1b (Safety run-in): Number of DLTs [Cohort A and Cohort B]
First 6 weeks of combination treatment

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.

Part 2 (Expansion) and Part 1b (Safety run-in): Progression free survival (PFS) rate [Cohort A subjects at RDE level]
At 15 months

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.

Part 2 (Expansion) and Part 1b (Safety run-in): Progression free survival (PFS) rate [Cohort B subjects at RDE level]
At 9 months

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.

Part 2 (Expansion) and Part 1b (Safety run-in): Progression free survival (PFS) rate [Cohort C subjects at RDE level]
At 6 months

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.

Secondary Endpoints

Overall response rate (ORR) per investigator assessment using RECIST v1.1
Up to 5 years
Duration of response (DOR) per investigator assessment using RECIST v1.1
Up to 5 years
Disease Control Rate (DCR) per investigator assessment using RECIST v1.1
Up to 5 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort A: 1st line colorectal cancerEXPERIMENTALTreatment for 1st line metastatic colorectal cancer (mCRC) with Gevokizumab, modified FOLFOX6, bevacizumab
Cohort B: 2nd line colorectal cancerEXPERIMENTALTreatment for 2nd line mCRC with Gevokizumab, FOLFIRI, bevacizumab
Cohort C: 2nd line gastroesophageal cancerEXPERIMENTALTreatment for 2nd line metastatic gastroesophageal cancer (mGEC) with Gevokizumab, paclitaxel, ramucirumab
Cohort D: 2nd or 3rd line renal cell carcinomaEXPERIMENTALTreatment for 2nd or 3rd line metastatic renal cell carcinoma (mRCC) with Gevokizumab, cabozantinib

Interventions

NameTypeDescription
GevokizumabDRUG60 mg/mL concentration; administered intravenously (IV)
BevacizumabDRUG25 mg/mL concentration; administered IV
Modified FOLFOX6DRUGOxaliplatin \[5 mg/mL concentration; administered IV\], leucovorin \[10 mg/mL concentration; administered IV\] (or levoleucovorin \[10 mg/mL concentration; administered IV\]), and 5-fluorouracil \[50 mg/mL concentration; administered IV\]
FOLFIRIDRUGIrinotecan \[20 mg/mL concentration; administered IV\], leucovorin \[10 mg/mL concentration; administered IV\] (or levoleucovorin \[10 mg/mL concentration; administered IV\]), and 5-fluorouracil \[50 mg/mL concentration; administered IV\]
RamucirumabDRUG10 mg/mL concentration; administered IV
PaclitaxelDRUG6 mg/mL concentration; administered IV
CabozantinibDRUG60 mg tablet; administered orally
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Eligibility Criteria

Age Range18 Years to 100 Years
SexALL
Healthy VolunteersNo
Study Sites34

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. * ...

Countries:United StatesAustraliaBelgiumCanadaChileCzechiaGermanyIsraelItalyJapanSingaporeSouth KoreaSpainTaiwanUnited Kingdom
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Frequently asked questions about Gevokizumab

What is Gevokizumab used for?

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.

Who makes Gevokizumab?

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.

What phase is Gevokizumab in?

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.

What clinical trials is Gevokizumab in?

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.

How does Gevokizumab work?

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.