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

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).