Gevokizumab + Standard Cancer Therapy for Colorectal and Gastroesophageal Cancers

Recruiting at 44 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Novartis Pharmaceuticals

Must be taking: Anti-cancer therapy

Must not be taking: CYP3A4/5 inhibitors

Disqualifiers: Brain metastases, Immunocompromised, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

167 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma, and the preliminary efficacy of gevokizumab in combination with the SOC anti-cancer therapy in subjects with mCRC and mGEC.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for adults with metastatic colorectal, gastroesophageal, or renal cancers that can't be removed by surgery. Participants must have specific types of these cancers at certain stages and meet criteria like having a measurable lesion and not needing immediate cancer treatment. They cannot join if they've had recent significant cardiovascular issues, are on certain drugs, or have brain metastases.

Inclusion Criteria

Your blood test shows high levels of a protein called hs-CRP.

My colorectal cancer is in its first stage of spreading.

I have clear-cell renal cancer, treated with an anti-angiogenic agent but it progressed.

Exclusion Criteria

I have a weakened immune system or an infection.

I am not taking any medications that are not allowed in the study.

I have brain metastases that cause symptoms or need specific treatment.

Treatment Details

Interventions

• Gevokizumab

Trial Overview The study tests the drug gevokizumab combined with standard cancer treatments (like FOLFOX6 or FOLFIRI for colorectal cancer) to find the right dose and see how well it works. It's given to patients who've already tried some treatments without success.

Participant Groups

Group I: Cohort D: 2nd or 3rd line renal cell carcinoma Experimental Treatment 2 Interventions

Treatment for 2nd or 3rd line metastatic renal cell carcinoma (mRCC) with Gevokizumab, cabozantinib

Group II: Cohort C: 2nd line gastroesophageal cancer Experimental Treatment 3 Interventions

Treatment for 2nd line metastatic gastroesophageal cancer (mGEC) with Gevokizumab, paclitaxel, ramucirumab

Group III: Cohort B: 2nd line colorectal cancer Experimental Treatment 3 Interventions

Treatment for 2nd line mCRC with Gevokizumab, FOLFIRI, bevacizumab

Group IV: Cohort A: 1st line colorectal cancer Experimental Treatment 3 Interventions

Treatment for 1st line metastatic colorectal cancer (mCRC) with Gevokizumab, modified FOLFOX6, bevacizumab

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD