Gevokizumab + Standard Cancer Therapy for Colorectal and Gastroesophageal Cancers

Recruiting in Palo Alto (17 mi)

+44 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Breakthrough Therapy

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.

See 6 more

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.

See 5 more

Treatment Details

Interventions

Gevokizumab (Monoclonal Antibodies)

Trial OverviewThe 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

4Treatment groups

Experimental Treatment

Group I: Cohort D: 2nd or 3rd line renal cell carcinomaExperimental Treatment2 Interventions

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

Group II: Cohort C: 2nd line gastroesophageal cancerExperimental Treatment3 Interventions

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

Group III: Cohort B: 2nd line colorectal cancerExperimental Treatment3 Interventions

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

Group IV: Cohort A: 1st line colorectal cancerExperimental Treatment3 Interventions

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