Solid Tumors
Conditions
Keywords
Advanced Solid Tumors, Metastatic Solid Tumors
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.
Interventions
DRUGXB371
Intravenous (IV) infusion.
Sponsors
Exelixis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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) |
| 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 |
Countries
United States
Contacts
CONTACTExelixis Clinical Trials
CONTACTBackup or International
STUDY_DIRECTORMedical Director
Exelixis
Outcome results
None listed