Clinical trial · Interventional
A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors
A Dose Escalation and Expansion Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors
NCT07123103CI-TRIAL-00103441recruitingPhase 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)
The primary purpose of the study is to characterize the safety and tolerability of XB371. The dose-escalation cohorts and Part B of the expansion cohorts are non-randomized. Part A of the expansion cohorts is randomized.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| XB371 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dose-escalation Cohorts
- description
- Participants will receive escalating doses of XB371 every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation.
- interventionNames
- Drug: XB371
- type
- EXPERIMENTAL
- label
- Dose-expansion Cohorts: Part A
- description
- Participants with Tumor Type 1 (tumor type will be selected based on available data) will be randomized to receive XB371 at one of two recommended dose levels (recommended dose \[RD\]-1 or RD-2) every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation.
- interventionNames
- Drug: XB371
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Minimum life expectancy of ≥ 12 weeks. * Recurrent locally advanced or metastatic solid tumors. * Adequate end organ and bone marrow function. Key Exclusion Criteria: * Primary brain tumors or known active brain metastases, leptomeningeal, or cranial epidural disease. * History of interstitial lung disease (ILD) of any grade or history of organizing pneumonia. * Has acute ocular infection, acute or chronic ulcerative/cicatricial condition of conjunctiva or cornea. * Known history of immunodeficiency virus (HIV) unless specific criteria are met. * Active infection with hepatitis C virus (HCV) defined as positive for HCV antibody. * Major surgery within 4 weeks before the first dose of study treatment. * Received radiation therapy within 2 weeks before the first dose of study treatment. * Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study treatment. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.