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TerminatedPhase 1

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

Key facts

Who runs it
Exelixis
Where
Austin, Denver, Houston, Huntersville, Jefferson, Nashville, New Haven, New York, and Washington D.C., United StatesSee the 10 sites
Trial code
Status
Terminated
Phase
Phase 1
People taking part
9 people enrolled
Started
17 Oct 2024
Ended
7 May 2025
Type of study
Interventional, 3 groups
Treatments tested
  • XL495
  • ADC cytotoxic agents
Record updated
25 June 2025
Why it stopped
Company Decision

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Prior anticancer treatment, including:; Radiation therapy within 2 weeks before first dose of study treatment
  • 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
  • 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
  • Active autoimmune disease with skin involvement

Where in United States

  • Austin, TexasHospital not named in the registryNo longer taking part
  • Denver, ColoradoHospital not named in the registryNo longer taking part
  • Houston, TexasHospital not named in the registryNo longer taking part
  • Huntersville, North CarolinaHospital not named in the registryNo longer taking part
  • Jefferson, LouisianaHospital not named in the registryNo longer taking part
  • Nashville, TennesseeHospital not named in the registryNo longer taking part
  • Nashville, TennesseeHospital not named in the registryNo longer taking part
  • New Haven, ConnecticutHospital not named in the registryNo longer taking part
  • New YorkHospital not named in the registryNo longer taking part
  • Washington D.C., District of ColumbiaHospital not named in the registryNo longer taking part

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Dose Escalation XL495Treatment being tested

    Group(s) of participants with advanced metastatic tumors who will receive increasing doses of XL495.

    Treatment: XL495

  • Dose Finding XL495 + ADC cytotoxic agentsTreatment being tested

    Group(s) of participants with advanced metastatic tumors who will receive XL495 and Antibody drug conjugate (ADC) cytotoxic agents together at increasing doses.

    Treatment: XL495 and ADC cytotoxic agents

  • Expansion XL495 + ADC cytotoxic agentsTreatment being tested

    Group(s) of participants with urothelial cancer who will receive XL495 and ADC cytotoxic agents at the recommended dosage(s) of expansion (RDE \[s\]) determined during the dose-escalation and dose-finding stages.

    Treatment: XL495 and ADC cytotoxic agents

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Record updated
25 June 2025