CAB-AXL-ADC Safety and Efficacy Study in Patients With Solid Tumors



Status:Recruiting
Conditions:Lung Cancer, Prostate Cancer, Skin Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/14/2019
Start Date:February 15, 2018
End Date:January 2022
Contact:Vanessa Esquibel
Email:vesquibel@bioatla.com
Phone:858-263-1598

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A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3011 in Patients With Advanced Solid Tumors

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.

This study will consist of a dose escalation phase and a dose expansion phase.

Inclusion Criteria:

- For the dose escalation phase: Patients with histologically or cytologically confirmed
locally advanced or metastatic solid tumor and have failed available standard of care
(SoC) therapy and for whom no curative therapy is available or who are not eligible,
intolerant to or refuse standard therapy.

- Patients must have measurable disease.

- For the dose expansion phase: Patients with locally advanced unresectable or
metastatic, non-small cell lung cancer (NSCLC), melanoma, and pancreatic ductal
adenocarcinoma (PDAC)

- Age ≥ 18 years.

- 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 received granulocyte colony stimulating factor (G-CSF) or
granulocyte/macrophage colony stimulating factor support 3 weeks prior to 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 Grade 2 or higher peripheral neuropathy.

- 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.
We found this trial at
8
sites
New York, New York 10065
Principal Investigator: Eileen M. O'Reilly, MD
Phone: 646-888-4303
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Matthew Taylor, MD
Phone: 503-418-9324
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Aurora, Colorado 80045
Principal Investigator: Robert Doebele, MD
Phone: 720-848-9382
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1800 North Williams Street
Denver, Colorado 80218
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Houston, Texas 77030
Principal Investigator: Jordi Rondon, MD
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Las Vegas, Nevada 89169
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Las Vegas, NV
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Howard Burris, MD
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Tampa, Florida 33612
Principal Investigator: Jingsong Zhang, MD
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Tampa, FL
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