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

Last updated: June 19, 2025
Sponsor: Exelixis
Overall Status: Terminated

Phase

1

Condition

Pelvic Cancer

Neoplasms

Treatment

XL495

ADC cytotoxic agents

Clinical Study ID

NCT06630247
XL495-101
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 9
Treatment Group(s): 2
Primary Treatment: XL495
Phase: 1
Study Start date:
October 17, 2024
Estimated Completion Date:
May 07, 2025

Connect with a study center

  • Exelixis Clinical Site #4

    Denver, Colorado 80218
    United States

    Site Not Available

  • Exelixis Clinical Site #9

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • Exelixis Clinical Site #8

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Exelixis Clinical Site #10

    Jefferson, Louisiana 70121
    United States

    Site Not Available

  • Exelixis Clinical Site #7

    New York, New York 10029
    United States

    Site Not Available

  • Exelixis Clinical SIte #2

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • Exelixis Clinical Site #3

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Exelixis Clinical Site #5

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Exelixis Clinical Site #1

    Austin, Texas 78758
    United States

    Site Not Available

  • Exelixis Clinical Site #6

    Houston, Texas 77030
    United States

    Site Not Available

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