Recruiting NCT07123103
A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: XB371.
- Who it may be relevant to
- Registry conditions: Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Dose Escalation and Expansion Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors
Overview
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.
Interventions
- Drug XB371
Intravenous (IV) infusion.
Primary outcome measures
- Number of Participants with a Dose-limiting Toxicity (DLT) [Time frame: Up to the end of the first cycle (Up to Day 21 of a 21-day cycle)]
- Number of Participants with a Treatment-emergent Adverse Event (TEAE) [Time frame: Up to approximately 7 months]
Secondary outcome measures (8)
- Area Under the Plasma Concentration-time Curve (AUC) of XB371, Total Antibody and Unconjugated Belotecan [Time frame: Up to approximately 7 months]
- Maximum Observed Plasma Concentration (Cmax) of XB371, Total Antibody and Unconjugated Belotecan [Time frame: Up to approximately 7 months]
- Time to Maximum Observed Plasma Concentration (Tmax) of XB371, Total Antibody and Unconjugated Belotecan [Time frame: Up to approximately 7 months]
- Trough Observed Plasma Concentration (Ctrough) of XB371, Total Antibody and Unconjugated Belotecan [Time frame: Up to approximately 7 months]
- Number of Participants with Antidrug Antibodies to XB371 [Time frame: Up to approximately 7 months]
- Dose-escalation Cohorts Only: Recommended Dose(s) for Expansion [Time frame: Through completion of dose-escalation (up to approximately 18 months)]
- Dose-expansion Cohorts Only: Objective Response Rate as Assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [Time frame: Up to approximately 18 months]
- Dose-expansion Cohorts Only: Duration of Response as Assessed by the Investigator per RECIST v1.1 [Time frame: Up to approximately 18 months]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 9 centers
- Exelixis Clinical Site #5 — Rogers
- Exelixis Clinical Site #9 — Los Angeles
- Exelixis Clinical Site #6 — Washington D.C.
- Exelixis Clinical Site #4 — Orlando
- Exelixis Clinical Site #3 — Grand Rapids
- Exelixis Clinical Site #7 — New Brunswick
- Exelixis Clinical Site #2 — Huntersville
- Exelixis Clinical Site #8 — Houston
- … and 1 more center
Identifiers
NCT: NCT07123103 · XB371-101