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Solid CancersPhase 1NCT06630247

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

A Phase 1 study testing XL495 and ADC cytotoxic agents in people with Solid Cancers and Solid Tumor Cancer, run by Exelixis at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
XL495 and ADC cytotoxic agents
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
10 sitesUnited States
Study dates
17 Oct 2024to 7 May 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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 join

  • 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.
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  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Exelixis Clinical Site #1

    Austin, Texas, 78758

  • Exelixis Clinical Site #4

    Denver, Colorado, 80218

  • Exelixis Clinical Site #6

    Houston, Texas, 77030

  • Exelixis Clinical SIte #2

    Huntersville, North Carolina, 28078

  • Exelixis Clinical Site #10

    Jefferson, Louisiana, 70121

  • Exelixis Clinical Site #3

    Nashville, Tennessee, 37203

  • Exelixis Clinical Site #5

    Nashville, Tennessee, 37203

  • Exelixis Clinical Site #9

    New Haven, Connecticut, 06511

  • Exelixis Clinical Site #7

    New York, New York, 10029

  • Exelixis Clinical Site #8

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

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

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.

Being tested
XL495, ADC cytotoxic agents
Keywords
solid tumor, renal tumor, metastatic solid tumor, urothelial carcinoma
Medical subject headings
Neoplasm Metastasis, Carcinoma, Renal Cell, Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XL495Drug

    oral doses of XL495

  • ADC cytotoxic agentsDrug

    intravenous infusion of anti-cancer combination agent

Study groups in NCT06630247
Study groupRoleWhat they receive
Dose Escalation XL495ExperimentalGroup(s) of participants with advanced metastatic tumors who will receive increasing doses of XL495.
Receives: Drug: XL495
Dose Finding XL495 + ADC cytotoxic agentsExperimentalGroup(s) of participants with advanced metastatic tumors who will receive XL495 and Antibody drug conjugate (ADC) cytotoxic agents together at increasing doses.
Receives: Drug: XL495; Drug: ADC cytotoxic agents
Expansion XL495 + ADC cytotoxic agentsExperimentalGroup(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.
Receives: Drug: XL495; Drug: ADC cytotoxic agents

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-escalation and Dose-finding Stages: Number of Participants with Treatment-Emergent Adverse Events

    Measured: Up to 18 months

  2. Dose-escalation and Dose-finding Stages: Number of Participants with Dose-limiting Toxicities

    Measured: Up to 18 months

  3. Expansion Stage: Number of Participants with Treatment-Emergent Adverse Events

    Measured: Up to 19 months

  4. Expansion Stage: Objective Response Rate (ORR) As Assessed by Investigator Per RECIST 1.1

    ORR is defined as the percentage of participants with the best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), as assessed by the Investigator per RECIST 1.1.

    Measured: Until disease progression or death, up to approximately 19 months

Secondary outcomes (14)

  1. Dose-escalation and Dose-finding Stages: Concentration of XL495 in Plasma

    Measured: Pre-dose and multiple post-dose time points, up to 18 months

  2. Dose-escalation and Dose-finding Stages: Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Time Curve (AUC) of XL495

    Measured: Pre-dose and multiple post-dose time points, up to 18 months

  3. Dose-escalation and Dose-finding Stages: PK Parameter Maximum Plasma Concentration of XL495 (Cmax)

    Measured: Pre-dose and multiple post-dose time points, up to 18 months

  4. Dose-escalation and Dose-finding Stages: PK Parameter Time to Cmax of XL495 (Tmax)

    Measured: Pre-dose and multiple post-dose time points, up to 18 months

  5. Dose-escalation and Dose-finding Stages: PK Parameter Apparent Clearance with Oral Administration of XL495 (CL/F)

    Measured: Pre-dose and multiple post-dose time points, up to 18 months

  6. Dose-escalation and Dose-finding Stages: PK Parameter Apparent Terminal Elimination Half-life of XL495 (t1/2)

    Measured: Pre-dose and multiple post-dose time points, up to 18 months

  7. Expansion Stage: Duration of Response (DOR) As Assessed by Investigator per RECIST 1.1

    DOR is defined as the time from the first documented objective response (CR or PR) until the earlier of radiographic progressive disease (PD) as assessed by the investigator per RECIST 1.1 or censoring due to lack of these events or start of non-protocol anti-cancer therapy.

    Measured: Until disease progression or death, up to approximately 19 months.

  8. Expansion Stage: Progression-free Survival (PFS), as Assessed by Investigator per RECIST 1.1

    PFS is defined as the time from start of study treatment to the earlier of either radiographic PD per RECIST 1.1 or death from any cause.

    Measured: Until disease progression or death, up to approximately 19 months.

  9. Expansion Stage: Concentration of XL495 in Plasma

    Measured: Pre-dose and multiple post-dose time points, up to 18 months

  10. Expansion Stage: Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Time Curve (AUC) of XL495

    Measured: Pre-dose and multiple post-dose time points, up to 18 months

  11. Expansion Stage: PK Parameter Maximum Plasma Concentration of XL495 (Cmax)

    Measured: Pre-dose and multiple post-dose time points, up to 18 months

  12. Expansion Stage: PK Parameter Time to Cmax of XL495 (Tmax)

    Measured: Pre-dose and multiple post-dose time points, up to 18 months

  13. Expansion Stage: PK Parameter Apparent Clearance with Oral Administration of XL495 (CL/F)

    Measured: Pre-dose and multiple post-dose time points, up to 18 months

  14. Expansion Stage: PK Parameter Apparent Terminal Elimination Half-life of XL495 (t1/2)

    Measured: Pre-dose and multiple post-dose time points, up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start17 Oct 2024
  3. Primary completion7 May 2025
  4. Study completion7 May 2025

Why it stopped: Company Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
This study is divided into three stages: The first stage is the dose escalation stage that evaluates how much of XL495 alone patients can safely tolerate. The second is the dose finding stage that evaluates how much of XL495 to give patients in combination with other anti-cancer medications. The third stage is the expansion stage that evaluates how XL495 performs in patients in combination with other anti-cancer medications.
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06630247
Sponsor's protocol ID
XL495-101
Status last verified
Jun 2025
First submitted
4 Oct 2024
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XL495 and ADC cytotoxic agents in people with Solid Cancers and Solid Tumor Cancer, run by Exelixis at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Company Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-escalation and Dose-finding Stages: Number of Participants with Treatment-Emergent Adverse Events (time frame: Up to 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06630247.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.

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