A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors
- Registration Number
- NCT07123103
- Lead Sponsor
- Exelixis
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose-escalation Cohorts XB371 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. Dose-expansion Cohorts: Part A XB371 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. Dose-expansion Cohorts: Part B XB371 Participants with Tumor Type 2 (tumor type will be selected based on available data) will receive XB371 at the recommended dose level every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation.
- Primary Outcome Measures
Name Time Method Number of Participants with a Dose-limiting Toxicity (DLT) 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) Up to approximately 7 months
- Secondary Outcome Measures
Name Time Method Area Under the Plasma Concentration-time Curve (AUC) of XB371, Total Antibody and Unconjugated Belotecan Up to approximately 7 months Maximum Observed Plasma Concentration (Cmax) of XB371, Total Antibody and Unconjugated Belotecan Up to approximately 7 months Time to Maximum Observed Plasma Concentration (Tmax) of XB371, Total Antibody and Unconjugated Belotecan Up to approximately 7 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) Up to approximately 18 months Dose-expansion Cohorts Only: Duration of Response as Assessed by the Investigator per RECIST v1.1 Up to approximately 18 months Trough Observed Plasma Concentration (Ctrough) of XB371, Total Antibody and Unconjugated Belotecan Up to approximately 7 months Number of Participants with Antidrug Antibodies to XB371 Up to approximately 7 months Dose-escalation Cohorts Only: Recommended Dose(s) for Expansion Through completion of dose-escalation (up to approximately 18 months)
Trial Locations
- Locations (1)
Exelixis Clinical Site #1
🇺🇸San Antonio, Texas, United States
Exelixis Clinical Site #1🇺🇸San Antonio, Texas, United States