A Dose-escalation, Dose-finding, and Expansion Study of XL495 in Participants With Locally Advanced or Metastatic Solid Tumors

Stopped early · Phase 1

Conditions studied: 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

In brief

The goal of this study is to obtain safety, tolerability, PK, and preliminary clinical antitumor activity for XL495 as a single agent and in combination with select cytotoxic agents in participants with locally advanced or metastatic tumors for whom life-prolonging therapies do not exist or available therapies are intolerable/no longer effective.

Key facts

Study ID

NCT06630247

Run by

Exelixis

People needed

9

Starts

2024-10-17

Expected to finish

2025-05-07

Last updated by the study team

2025-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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