Clinical Trials

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 Cohort C:

- 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

Eligibility last updated 6/8/22. Questions regarding updates should be directed to the study team contact.