Clinical trial NCT06545331: Study of XB010 in Subjects With Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Locally Advanced or Metastatic Solid Tumors
Esophageal Squamous Cell Cancer
Head and Neck Squamous Cell Cancer
NSCLC (Non-small Cell Lung Cancer)
Hormone-receptor-positive Breast Cancer
Triple Negative Breast Cancer (TNBC)
Lead sponsor: Exelixis
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study consists of Dose-Escalation and Cohort-Expansion Stages. The Dose-Escalation Stage is designed to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE\[s\]) of XB010 as a single agent, and to evaluate XB010 monotherapy RDE(s) in combination with pembrolizumab. The Cohort-Expansion Stage is designed to explore the clinical activity and further characterize the safety and tolerability of XB010 as monotherapy in multiple tumor-specific cohorts.

Eligibility criteria: * 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.

Primary outcomes:
measure: Dose-Escalation Stage: Maximum tolerated dose (MTD) and/or Recommended dose(s) for Expansion [RDE(s)] for XB010
timeFrame: 18 months
measure: Dose-Escalation Stage: Safety of XB010
timeFrame: 18 months
measure: Dose-Escalation Stage: Duration of exposure of XB010 [Tolerability]
timeFrame: 18 months
measure: Dose-Escalation Stage: Dose intensity of XB010 [Tolerability]
timeFrame: 18 months
measure: Cohort-Expansion Stage: Preliminary antitumor activity of XB010
timeFrame: 24 months
Secondary outcomes:
measure: Dose-Escalation Stage: Maximum Plasma Concentration (Cmax) of XB010
timeFrame: 18 Months
measure: Dose-Escalation Stage: Time to Maximum Plasma Concentration (Tmax) of XB010
timeFrame: 18 Months
measure: Dose-Escalation Stage: Clearance of XB010
timeFrame: 18 Months
measure: Dose-Escalation Stage: Area Under the Plasma Concentration Curve (AUC) of XB010
timeFrame: 18 Months
measure: Dose-Escalation Stage: Minimum Plasma Concentration (Cmin) of XB010
timeFrame: 18 Months
measure: Dose-Escalation Stage: Immunogenicity of XB010
timeFrame: 18 Months
measure: Cohort-Expansion Stage: Duration of exposure of XB010 [Tolerability]
timeFrame: 24 Months
measure: Cohort-Expansion Stage: Dose intensity of XB010 [Tolerability]
timeFrame: 24 Months
measure: Cohort-Expansion Stage: Maximum Plasma Concentration (Cmax) of XB010
timeFrame: 24 Months
measure: Cohort-Expansion Stage: Time to Maximum Plasma Concentration (Tmax) of XB010
timeFrame: 24 Months
measure: Cohort-Expansion Stage: Clearance of XB010
timeFrame: 24 Months
measure: Cohort-Expansion Stage: Area Under the Plasma Concentration Curve (AUC) of XB010
timeFrame: 24 Months
measure: Cohort-Expansion Stage: Minimum Plasma Concentration (Cmin) of XB010
timeFrame: 24 Months
measure: Cohort-Expansion Stage: Immunogenicity of XB010
timeFrame: 24 Months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: Exelixis Clinical Site #4
state: California
city: Saint Louis
country: United States
facility: Exelixis Clinical Site #5
state: Missouri
city: Huntersville
country: United States
facility: Exelixis Clinical Site #3
state: North Carolina
city: Oklahoma City
country: United States
facility: Exelixis Clinical Site #6
state: Oklahoma
city: Austin
country: United States
facility: Exelixis Clinical Site #1
state: Texas
city: Dallas
country: United States
facility: Exelixis Clinical Site #7
state: Texas
city: Houston
country: United States
facility: Exelixis Clinical Site #8
state: Texas
city: Fairfax
country: United States
facility: Exelixis Clinical Site #2
state: Virginia
Study officials:
References: