NCT06545331 Study of XB010 in Subjects With Solid Tumors
| NCT ID | NCT06545331 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Exelixis |
| Condition | Locally Advanced or Metastatic Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 396 participants |
| Start Date | 2024-08-06 |
| Primary Completion | 2026-11-23 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 396 participants in total. It began in 2024-08-06 with a primary completion date of 2026-11-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Study Director
STUDY DIRECTOR
Exelixis
Frequently Asked Questions
Who can join the NCT06545331 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Advanced or Metastatic Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06545331 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06545331 currently recruiting?
Yes, NCT06545331 is actively recruiting participants. Contact the research team at druginfo@exelixis.com for enrollment information.
Where is the NCT06545331 trial being conducted?
This trial is being conducted at Irvine, United States, Los Angeles, United States, Washington D.C., United States, Orlando, United States and 11 additional locations.
Who is sponsoring the NCT06545331 clinical trial?
NCT06545331 is sponsored by Exelixis. The principal investigator is Study Director at Exelixis. The trial plans to enroll 396 participants.