A Dose-escalation, Dose-finding, and Expansion Study of XL495 as a Single Agent and in Combination Therapy in Participants With Locally Advanced or Metastatic Solid Tumors

Inclusion Criteria

• For All Participants
  • Have received at least one standard therapy unless it does not exist, or available therapies are intolerable or no longer effective.
  • For participants, who qualify for approved molecularly selected therapies such as RAS inhibitors, they must have progressed on, relapsed from, been intolerant to, ineligible, or refused those therapies.
• Expansion Stage
  • Diagnosis of metastatic advanced UC (primary tumor: renal pelvis, ureter, urinary bladder, or urethra).
  • At least one measurable lesion as defined by RECIST, version 1.1.
  • Participants must be eligible for sacituzumab govitecan treatment as their next line of therapy.
• At least one but no more than 3 prior lines of therapy.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (0-2 for monotherapy; 0-1 for combo)

Exclusion Criteria

• Prior anticancer treatment, including:
  • Radiation therapy within 2 weeks before first dose of study treatment.
• Known brain metastases or cranial epidural disease
• Current or recent severe illness
• Known history or positive test for human immunodeficiency virus (HIV) unless meets specific criteria.
• Active infection with hepatitis B virus or hepatitis C virus.
• Malabsorption syndrome.
• History of solid organ, autologous or allogenic stem cell transplant.
• Diagnosis of another cancer within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with standard therapy.
• Active autoimmune disease with skin involvement.