Trial | NCT03425279  Report issue

Title

Phase 2 CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma
A Phase 1/ 2 Safety and Efficacy Dose Escalation / Dose Expansion Study of a CAB-AXL-ADC, Alone and in Combination With a PD-1 Inhibitor in Adult Patients With Advanced Solid Tumors (Phase 1) and Adult and Adolescent Patients With Advanced, Refractory Sarcoma (Phase 2)

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Recruiting

  • Intervention/Treatment

    CAB-AXL-ADC ...

  • Study Participants

    120
The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in solid tumors
This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3011, a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC) in patients with advanced solid tumors in Phase 1 and BA3011 alone and in combination with a PD-1 inhibitor in Phase 2.

Phase 1 of this study will consist of a dose escalation phase (enrollment complete as of Oct 2019) and a dose expansion phase (still enrolling ACC patients only).

Phase 2 is targeted to begin in Q3 2020 and will include both adult and adolescents age 12 and over.
Study Started
Feb 15
2018
Primary Completion
Dec 31
2024
Anticipated
Study Completion
Dec 31
2024
Anticipated
Last Update
Jul 13
2022

Biological CAB-AXL-ADC

Conditionally active biologic anti-AXL antibody drug conjugate

Biological PD-1 inhibitor

PD-1 inhibitor

BA3011 Experimental

Phase 1: All patients will receive BA3011, CAB-AXL-ADC. Phase 2: All patients will receive either BA3011 alone or in combination with PD-1 inhibitor.

Combination Therapy Experimental

Phase 2: BA3011 in combination with PD-1 inhibitor.

Criteria 

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 wellas 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.
No Results Posted