Clinical trial · Interventional
Study of XB010 in Subjects With Solid Tumors
A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors
NCT06545331CI-TRIAL-00115387recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Cancer | Esophageal Squamous Cell Carcinoma | ALIAS | 0.90 |
| Head and Neck Squamous Cell Cancer | — | UNRESOLVED | — |
| Hormone-receptor-positive Breast Cancer | — | UNRESOLVED | — |
| Locally Advanced or Metastatic Solid Tumors | — | UNRESOLVED | — |
| NSCLC (Non-small Cell Lung Cancer) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| Triple Negative Breast Cancer (TNBC) | Triple-Negative Breast Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| XB010 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- XB010 Single-Agent Dose Escalation Cohorts
- description
- XB010 will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects
- interventionNames
- Drug: XB010
- type
- EXPERIMENTAL
- label
- XB010 + Pembrolizumab Dose Escalation Cohorts
- description
- XB010+Pembrolizumab will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects
- interventionNames
- Drug: XB010
- Drug: Pembrolizumab
- type
- EXPERIMENTAL
- label
- XB010 Single-Agent Dose Expansion Cohorts
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* 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.
References
Publications (0)
Data not yet available
No reference posted for this study.