Esophageal Squamous Cell Cancer, Head and Neck Squamous Cell Cancer, Hormone-receptor-positive Breast Cancer, Locally Advanced or Metastatic Solid Tumors, NSCLC (Non-small Cell Lung Cancer), Triple Negative Breast Cancer (TNBC)
Conditions
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.
Interventions
DRUGXB010
IV administration of XB010
DRUGPembrolizumab
IV administration of Pembrolizumab
Sponsors
Exelixis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-Escalation Stage: Maximum tolerated dose (MTD) and/or Recommended dose(s) for Expansion [RDE(s)] for XB010 | 18 months | To determine the MTD and/or RDE(s) for further evaluation of IV administration of XB010 alone and in combination therapy. |
| Dose-Escalation Stage: Safety of XB010 | 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) |
| Dose-Escalation Stage: Duration of exposure of XB010 [Tolerability] | 18 months | To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the duration of exposure of each component |
| Dose-Escalation Stage: Dose intensity of XB010 [Tolerability] | 18 months | To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the dose intensity of each component |
| Cohort-Expansion Stage: Preliminary antitumor activity of XB010 | 24 months | Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose-Escalation Stage: Maximum Plasma Concentration (Cmax) of XB010 | 18 Months | To evaluate the maximum plasma concentration of XB010 alone and in combination. |
| Dose-Escalation Stage: Time to Maximum Plasma Concentration (Tmax) of XB010 | 18 Months | To evaluate the time to maximum plasma concentration of XB010 alone and in combination. |
| Dose-Escalation Stage: Clearance of XB010 | 18 Months | To evaluate the volume of plasma cleared of XB010 alone and in combination for a specified time period |
| Dose-Escalation Stage: Area Under the Plasma Concentration Curve (AUC) of XB010 | 18 Months | To measure the Area Under the Plasma Concentration Curve of XB010 alone and in combination |
| Dose-Escalation Stage: Minimum Plasma Concentration (Cmin) of XB010 | 18 Months | To evaluate the minimum plasma concentration of XB010 alone and in combination |
| Dose-Escalation Stage: Immunogenicity of XB010 | 18 Months | To assess the immunogenicity of XB010 alone and in combination as measured by anti-drug antibody (ADA) analysis |
| Cohort-Expansion Stage: Duration of exposure of XB010 [Tolerability] | 24 Months | To evaluate the tolerability of XB010 through the evaluation of the duration of exposure |
| Cohort-Expansion Stage: Dose intensity of XB010 [Tolerability] | 24 Months | To evaluate the tolerability of XB010 through the evaluation of the dose intensity |
| Cohort-Expansion Stage: Maximum Plasma Concentration (Cmax) of XB010 | 24 Months | To evaluate the maximum plasma concentration of XB010 |
| Cohort-Expansion Stage: Time to Maximum Plasma Concentration (Tmax) of XB010 | 24 Months | To evaluate the time to maximum plasma concentration of XB010 |
| Cohort-Expansion Stage: Clearance of XB010 | 24 Months | To evaluate the volume of plasma cleared of XB010 for a specified time period |
| Cohort-Expansion Stage: Area Under the Plasma Concentration Curve (AUC) of XB010 | 24 Months | To measure the Area Under the Plasma Concentration Curve of XB010 |
| Cohort-Expansion Stage: Minimum Plasma Concentration (Cmin) of XB010 | 24 Months | To evaluate the minimum plasma concentration of XB010 |
| Cohort-Expansion Stage: Immunogenicity of XB010 | 24 Months | To assess the immunogenicity of XB010 as measured by anti-drug antibody (ADA) analysis |
Countries
United Kingdom, United States
Contacts
CONTACTExelixis Clinical Trials
CONTACTBackup or International
STUDY_DIRECTORStudy Director
Exelixis
Outcome results
None listed