Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- Adequate bone marrow and organ function per defined criteria in the protocol.
- Recovered from acute laboratory and clinical toxicities of prior anti cancer treatment to NCI CTCAE v5.0 grade ≤1 at time of screening, except alopecia and amenorrhea.
For Cohort A:
• First line metastatic colorectal adenocarcinoma.
For Cohort B:
• Second line metastatic colorectal adenocarcinoma that has progressed on prior line of chemotherapy administered for metastatic disease and which must include a fluoropyrimidine and oxaliplatin.
For Cohort C:
• Second line metastatic gastroesophageal adenocarcinoma 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 (per central laboratory assessment).
- Not requiring immediate initiation of anti cancer therapy per investigator's best judgement.
For subjects starting from Part 2 in Cohort C:
• Serum hs CRP at screening ≥ 10 mg/L (per central laboratory assessment).
Key Exclusion Criteria:
For All Cohorts:
- Currently receiving any of the prohibited medications or has contraindications as outlined in the 'Contraindications' to SOC regimen components.
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
167 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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