Brief Title: XL495 in Participants With Locally Advanced or Metastatic Solid Tumors

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

• Solid Cancers
• Solid Tumor Cancer
• Solid Tumor Malignancy
• Urothelial Cancer (Urinary Bladder
• Ureters
• or Renal Pelvis Cancer)
• Metastatic Solid Tumor
• Locally Advanced Solid Tumor
• Urothelial Cancer of Renal Pelvis

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: Exelixis Clinical Trials

Phone: 1-888-393-5494

Email: Druginfo@exelixis.com

LOCATION