To hear about similar clinical trials, please enter your email below
Trial Title:
Study of XB010 in Subjects With Solid Tumors
NCT ID:
NCT06545331
Condition:
Locally Advanced or Metastatic Solid Tumors
Conditions: Official terms:
Neoplasms
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
XB010
Description:
IV administration of XB010
Arm group label:
XB010 + Pembrolizumab Dose Escalation Cohorts
Arm group label:
XB010 Single-Agent Dose Escalation Cohorts
Arm group label:
XB010 Single-Agent Dose Expansion Cohorts
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
IV administration of Pembrolizumab
Arm group label:
XB010 + Pembrolizumab Dose Escalation Cohorts
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.
Criteria for 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, Pancreatic Cancer, Endometrial Cancer, Triple-Negative Breast
Cancer).
- Capable of understanding and complying with the protocol requirements and must have
signed the informed consent document.
- Available archival tumor tissue
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Exelixis Clinical Site #4
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #3
Address:
City:
Huntersville
Zip:
28078
Country:
United States
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #1
Address:
City:
Austin
Zip:
78758
Country:
United States
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #2
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Start date:
August 6, 2024
Completion date:
October 20, 2027
Lead sponsor:
Agency:
Exelixis
Agency class:
Industry
Source:
Exelixis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06545331
