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NCT06545331 · ClinicalTrials.gov registry record · Phase 1
Study of XB010 in Subjects With Solid Tumors
A Phase 1 study of Hormone Receptor-Positive Breast Cancer and Triple Negative Breast Cancer (TNBC), sponsored by Exelixis.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 396
- Enrollment target
- 17
- Study locations
NCT06545331 is a Phase 1 study of Hormone Receptor-Positive Breast Cancer and Triple Negative Breast Cancer (TNBC) that is actively recruiting participants, run by Exelixis. The registered enrollment target is 396 participants, above the 171-participant average among 23 other Hormone Receptor-Positive Breast Cancer trials with a reported enrollment target (132% higher). The trial reports 17 study locations across 11 states.
The verdict
NCT06545331, a Phase 1 study of Hormone Receptor-Positive Breast Cancer and Triple Negative Breast Cancer (TNBC), is actively recruiting participants, sponsored by Exelixis.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 396 participants
- Enrollment target
- 17
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG XB010
Study Locations (17)
England
- Exelixis Clinical Site #17 - Leicester
- Exelixis Clinical Site #13 - London
- Exelixis Clinical Site #16 - London
- Exelixis Clinical Site #14 - Manchester
Texas
- Exelixis Clinical Site #1 - Austin
- Exelixis Clinical Site #7 - Dallas
- Exelixis Clinical Site #8 - Houston
Virginia
- Exelixis Clinical Site #11 - Fairfax
- Exelixis Clinical Site #2 - Fairfax
California
- Exelixis Clinical Site #4 - Irvine
District of Columbia
- Exelixis Clinical Site #10 - Washington D.C.
Georgia
- Exelixis Clinical Site #12 - Atlanta
Illinois
- Exelixis Clinical Site #15 - Chicago
Missouri
- Exelixis Clinical Site #5 - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 396 participants |
| Start Date | 2024-08-06 |
| Est. Completion | 2027-10-20 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06545331
The ClinicalTrials.gov registry entry for NCT06545331 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 396 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 171-participant average among 23 other Hormone Receptor-Positive Breast Cancer trials with a reported enrollment target (132% higher). The listed sponsor is Exelixis, which has 48 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Hormone Receptor-Positive Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT06545331 reports 17 study locations spanning 11 distinct geographic areas - top geographies include England, Texas, Virginia.
Frequently Asked Questions
What is clinical trial NCT06545331 about?
NCT06545331 is a clinical study titled "Study of XB010 in Subjects With Solid Tumors". 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 t...
What is the current status of trial NCT06545331?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 396 participants. The study started on 2024-08-06. Estimated completion is 2027-10-20.
What conditions does trial NCT06545331 study?
This clinical trial studies the following conditions: Hormone Receptor-Positive Breast Cancer, Triple Negative Breast Cancer (TNBC), NSCLC (Non-small Cell Lung Cancer), Locally Advanced or Metastatic Solid Tumors, Head and Neck Squamous Cell Cancer.
What interventions are being tested in trial NCT06545331?
The interventions under investigation include: Pembrolizumab (DRUG), XB010 (DRUG).
Who is sponsoring clinical trial NCT06545331?
This trial is sponsored by Exelixis, which has 48 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06545331 being conducted?
This trial has 17 study locations across California, District of Columbia, Georgia, Illinois, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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