Testing XL495 for advanced solid tumors

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

This study is testing a new treatment called XL495 for people with advanced solid tumors to see if it is safe and effective, especially for those who have already tried other therapies.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 124 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Exelixis (industry)
• Drugs / interventions: sacituzumab, Radiation
• Locations: 10 sites (Denver, Colorado and 9 other locations)
• Trial ID: NCT06630247 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of XL495, both as a standalone treatment and in combination with certain cytotoxic agents, in patients with locally advanced or metastatic solid tumors. Participants must have previously received at least one standard therapy or have no effective treatment options available. The study focuses on patients with advanced urothelial cancer and requires measurable lesions for assessment. It is designed to identify the appropriate dosing and potential effectiveness of XL495 in this challenging patient population.

Who should consider this trial

Good fit: Ideal candidates include patients with metastatic urothelial cancer who have progressed on prior therapies and are eligible for specific next-line treatments.

Not a fit: Patients who have not received prior anticancer treatments or those with known brain metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited or no effective treatments available.

How similar studies have performed: Other studies have shown promise with similar approaches in treating advanced solid tumors, but this specific combination and dosing strategy may be novel.

Eligibility criteria

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.

Where this trial is running

Denver, Colorado and 9 other locations

• Exelixis Clinical Site #4 — Denver, Colorado, United States (RECRUITING)
• Exelixis Clinical Site #9 — New Haven, Connecticut, United States (RECRUITING)
• Exelixis Clinical Site #8 — Washington, District of Columbia, United States (RECRUITING)
• Exelixis Clinical Site #10 — Jefferson, Louisiana, United States (RECRUITING)
• Exelixis Clinical Site #7 — New York, New York, United States (RECRUITING)
• Exelixis Clinical SIte #2 — Huntersville, North Carolina, United States (RECRUITING)
• Exelixis Clinical Site #3 — Nashville, Tennessee, United States (RECRUITING)
• Exelixis Clinical Site #5 — Nashville, Tennessee, United States (RECRUITING)
• Exelixis Clinical Site #1 — Austin, Texas, United States (RECRUITING)
• Exelixis Clinical Site #6 — Houston, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Exelixis Clinical Trials

Conditions: Solid Cancers, Solid Tumor Cancer, Solid Tumor Malignancy, Urothelial Cancer, Metastatic Solid Tumor, Locally Advanced Solid Tumor, Urothelial Cancer of Renal Pelvis, solid tumor