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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: Recruiting Phase 1 study of Hormone Receptor-Positive Breast Cancer and Triple Negative Breast Cancer (TNBC), sponsored by Exelixis.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine the MTD and/or RDE(s) for further evaluation of IV administration of XB010 alone and in combination therapy.
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 |
What NCT06545331 shows while recruiting
NCT06545331 is an interventional study that assigns participants to a tested intervention. The registered 396 participants enrollment target is mid-sized for trials with a published cap, above the 171-participant average among 23 other Hormone Receptor-Positive Breast Cancer trials with a reported enrollment target (132% higher).
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 lists 17 locations in 11 states (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.
Learn More About Clinical Trials
Similar trials for Hormone Receptor-Positive Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06545331's enrollment target sits among peer trials
396 2nd of 23 the highest of 23 other Hormone Receptor-Positive Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hormone Receptor-Positive Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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