CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma (NCT03425279) | Clinical Trial Compass
CompletedPhase 1/2
CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma
United States245 participantsStarted 2018-02-15
Plain-language summary
The objective of this study is to assess the safety and efficacy of mecbotamab vedotin (BA3011) in solid tumors.
Who can participate
Age range12 Years
SexALL
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Inclusion Criteria:
* Patients must have measurable disease.
* Age ≥ 12 years (Phase 2)
* Adequate renal function
* Adequate liver function
* Adequate hematological function
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of at least three months.
Exclusion Criteria:
* Patients must not have clinically significant cardiac disease.
* Patients must not have known non-controlled CNS metastasis.
* Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study.
* Patients must not have had major surgery within 4 weeks before first BA3011 administration.
* Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
* Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
* Patients must not be women who are pregnant or breast feeding.
What they're measuring
1
Phase 1: Safety Profile
Timeframe: Up to 24 months
2
Phase 1: Safety Profile
Timeframe: Up to 24 months
3
Phase 1 and 2: Safety Profile
Timeframe: Up to 24 months
4
Phase 2: Confirmed overall response rate (ORR) per RECIST v1.1