Open Actively Recruiting

Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers

About

Brief Summary

This study will determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose and preliminary efficacy 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • 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. For Cohort A:
  • First line metastatic colorectal cancer. For Cohort B:
  • Second line metastatic colorectal cancer that has progressed on prior chemotherapy administered for metastatic disease and which must include a fluoropyrimidine and oxaliplatin. For Cohort C:
  • Second line metastatic gastroesophageal cancer that has progressed on prior line of chemotherapy administered for metastatic disease, and which must include a platinum agent and fluoropyrimidine doublet. For Cohort D:
  • Second or third line metastatic renal cell carcinoma with a clear-cell component and has received one or two lines of treatment for metastatic disease that included an anti-angiogenic agent for at least 4 weeks with radiologic progression on that treatment. For subjects starting from Part 1a in Cohorts A and B:
    • Serum hs-CRP at screening ≥ 10 mg/L.
    • Not requiring immediate initiation of anti-cancer therapy per investigator's best judgement. For subjects starting from Part 2 in Cohorts C and D:
  • Serum hs-CRP at screening ≥ 10 mg/L.

Exclusion Criteria:

For All Cohorts:

  • Currently receiving any of the prohibited medications or has contraindications as outlined in the protocol.
  • Symptomatic brain metastases or brain metastases that require directed therapy (such as focal radiotherapy or surgery).
  • Suspected or proven immunocompromised state, or infections (as defined in the protocol).
  • Conditions that have a high risk of clinically significant bleeding after administration of anti-VEGF agents.
  • Clinically significant, uncontrolled or recent (within last 6 months) cardiovascular disease. For Cohort D:
  • Concomitant medications, herbal supplements, and/or fruits and their juices that are known as strong inhibitors or inducers of CYP3A4/5, and medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
  • Impairment of GI function or GI disease that may significantly alter the absorption of cabozantinib.

Other protocol-defined inclusion/exclusion criteria may apply

Join this Trial

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Study Stats
Protocol No.
19-000922
Category
Hematology-Oncology
Oncology
Contact
Rachel Andes
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT03798626
For detailed technical eligibility, visit ClinicalTrials.gov.