Study of XB010 in Subjects With Solid Tumors

NCT06545331
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Recruiting
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Participants
396
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Lead sponsor
Exelixis
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Start date
2024-08-06
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Number of sites
20
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Summary
This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.
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Short title
Study of XB010 in Subjects With Solid Tumors
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Official title
A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-10-20
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First posted
2024-08-09
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Registry last updated
2026-06-22
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Primary completion date
2026-11-23
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Start date
2024-08-06
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Participants
396
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Participant count basis
Estimated
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Planned participants
396
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Protocol amendments
1
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Number of sites
20
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Exelixis
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06545331
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ClinicalTrials.gov ID
NCT06545331
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Dose-Escalation Stage: Maximum tolerated dose (MTD) and/or Recommended dose(s) for Expansion [RDE(s)] for XB010

    Timeframe: 18 months

    To determine the MTD and/or RDE(s) for further evaluation of IV administration of XB010 alone and in combination therapy.

  2. Dose-Escalation Stage: Safety of XB010

    Timeframe: 18 months

    To evaluate the safety of XB010 alone and in combination therapy through the evaluation of incidence and severity of nonserious adverse events (AEs) and serious adverse events (SAEs)

  3. Dose-Escalation Stage: Duration of exposure of XB010 [Tolerability]

    Timeframe: 18 months

    To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the duration of exposure of each component

  4. Dose-Escalation Stage: Dose intensity of XB010 [Tolerability]

    Timeframe: 18 months

    To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the dose intensity of each component

  5. Cohort-Expansion Stage: Preliminary antitumor activity of XB010

    Timeframe: 24 months

    Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1

  1. Dose-Escalation Stage: Maximum Plasma Concentration (Cmax) of XB010

    Timeframe: 18 Months

    To evaluate the maximum plasma concentration of XB010 alone and in combination.

  2. Dose-Escalation Stage: Time to Maximum Plasma Concentration (Tmax) of XB010

    Timeframe: 18 Months

    To evaluate the time to maximum plasma concentration of XB010 alone and in combination.

  3. Dose-Escalation Stage: Clearance of XB010

    Timeframe: 18 Months

    To evaluate the volume of plasma cleared of XB010 alone and in combination for a specified time period

  4. Dose-Escalation Stage: Area Under the Plasma Concentration Curve (AUC) of XB010

    Timeframe: 18 Months

    To measure the Area Under the Plasma Concentration Curve of XB010 alone and in combination

  5. Dose-Escalation Stage: Minimum Plasma Concentration (Cmin) of XB010

    Timeframe: 18 Months

    To evaluate the minimum plasma concentration of XB010 alone and in combination

  6. Dose-Escalation Stage: Immunogenicity of XB010

    Timeframe: 18 Months

    To assess the immunogenicity of XB010 alone and in combination as measured by anti-drug antibody (ADA) analysis

  7. Cohort-Expansion Stage: Duration of exposure of XB010 [Tolerability]

    Timeframe: 24 Months

    To evaluate the tolerability of XB010 through the evaluation of the duration of exposure

  8. Cohort-Expansion Stage: Dose intensity of XB010 [Tolerability]

    Timeframe: 24 Months

    To evaluate the tolerability of XB010 through the evaluation of the dose intensity

  9. Cohort-Expansion Stage: Maximum Plasma Concentration (Cmax) of XB010

    Timeframe: 24 Months

    To evaluate the maximum plasma concentration of XB010

  10. Cohort-Expansion Stage: Time to Maximum Plasma Concentration (Tmax) of XB010

    Timeframe: 24 Months

    To evaluate the time to maximum plasma concentration of XB010

  11. Cohort-Expansion Stage: Clearance of XB010

    Timeframe: 24 Months

    To evaluate the volume of plasma cleared of XB010 for a specified time period

  12. Cohort-Expansion Stage: Area Under the Plasma Concentration Curve (AUC) of XB010

    Timeframe: 24 Months

    To measure the Area Under the Plasma Concentration Curve of XB010

  13. Cohort-Expansion Stage: Minimum Plasma Concentration (Cmin) of XB010

    Timeframe: 24 Months

    To evaluate the minimum plasma concentration of XB010

  14. Cohort-Expansion Stage: Immunogenicity of XB010

    Timeframe: 24 Months

    To assess the immunogenicity of XB010 as measured by anti-drug antibody (ADA) analysis

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Age 18 years or older on the day of consent.

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.

  • Adequate organ and marrow function.

  • Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent.

    • The Cohort Expansion stage will enroll subjects with multiple tumor types (non-small cell lung cancer, hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell, triple-negative breast cancer).

  • Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.

Sources for eligibility
clinicaltrials.gov

  • City of Hope Orange County Lennar Foundation Cancer CenterIrvine, United StatesRecruiting
  • UCLA Department of Medicine - Hematology/OncologyLos Angeles, United StatesRecruiting
  • Georgetown University Medical CenterWashington D.C., United StatesRecruiting
  • Sarah Cannon Research Institute at Florida Cancer SpecialistsOrlando, United StatesRecruiting
  • Winship Cancer InstituteAtlanta, United StatesRecruiting
  • University of Chicago Medical CenterChicago, United StatesRecruiting
  • Siteman Cancer CenterSt Louis, United StatesRecruiting
  • Montefiore Medical Center - Montefiore Medical ParkThe Bronx, United StatesRecruiting
  • Carolina BioOncology InstituteHuntersville, United StatesRecruiting
  • Stephenson Cancer CenterOklahoma City, United StatesRecruiting
  • SCRI Oncology PartnersNashville, United StatesRecruiting
  • NEXT AustinAustin, United StatesRecruiting
  • Baylor University Medical CenterDallas, United StatesRecruiting
  • University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting
  • Inova Schar CancerFairfax, United StatesRecruiting
  • NEXT VirginiaFairfax, United StatesRecruiting
  • University Hospitals of Leicester NHS TrustLeicester, United KingdomRecruiting
  • Sarah Cannon Research Institute LondonLondon, United KingdomRecruiting
  • University College London Hospitals NHS Foundation TrustLondon, United KingdomRecruiting
  • The Christie NHS Foundation TrustManchester, United KingdomRecruiting
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 1012465
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (4)

Targets (1)