Phase 2 CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma

a study on Sarcoma Liposarcoma Synovial Sarcoma Bone Cancer Osteosarcoma Ewing Sarcoma Solid Tumor

Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Brian Schulte, MD
Headshot of Brian Schulte
Brian Schulte

Description

Summary

The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in solid tumors

Official Title

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)

Details

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.

Keywords

Undifferentiated Pleomorphic Sarcoma, Liposarcoma, Synovial Sarcoma, Osteosarcoma, Ewing Sarcoma, late stage, stage 3, stage 4, cancer, Sarcoma, Malignant Fibrous Histiocytoma, Immune Checkpoint Inhibitors, CAB-AXL-ADC, PD-1 inhibitor

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCSF Medical Center - Cancer Immunotherapy Clinic (CIC) accepting new patients
    San Francisco California 94158 United States
  • Children's Hospital Los Angeles accepting new patients
    Los Angeles California 90027 United States
  • Tower Hematology Oncology Medical Group accepting new patients
    Los Angeles California 90048 United States

Lead Scientist at UCSF

  • Brian Schulte, MD
    Dr. Brian Schulte is a hematologist-oncologist who cares for patients with sarcomas, rare cancers that develop in connective tissues (such as bone, muscle or cartilage) and can affect people of all ages. Working as part of a multidisciplinary team, he strives to ensure patients receive the best possible comprehensive care.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BioAtla, Inc.
ID
NCT03425279
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated
Contact us about this trial