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Recruiting Phase 1 NCT06545331

Study of XB010 in Subjects With Solid Tumors

Trial Parameters

Condition Locally Advanced or Metastatic Solid Tumors
Sponsor Exelixis
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 396
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-08-06
Completion 2026-11-23
Interventions
XB010Pembrolizumab

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.

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