A PHASE 1/2 DOSE ESCALATION AND DOSE EXPANSION STUDY OF OZURIFTAMAB VEDOTIN (BA3021) ALONE AND IN COMBINATION WITH NIVOLUMAB IN PATIENTS WITH ADVANCED SOLID TUMORS

NOT ENROLLING
Protocol # :
21-248
Conditions
Non Small Cell Lung Cancer
Triple Negative Breast Cancer
Melanoma
Head and Neck Cancer
Phase
I/II
Disease Sites
Healthy volunteer
Transplanted organ and tissue status, unspecified
Disease not specified
Neuroendocrine/Carcinoid
Gastroesophageal Junction
Gallbladder/Biliary
Other specified personal risk factors, not elsewhere classified
Lip, Oral Cavity and Pharynx
Esophagus
Stomach
Small Intestine
Colon
Rectum
Anus
Liver
Pancreas
Other Digestive Organ
Larynx
Lung
Other Respiratory and Intrathoracic Organs
Bones and Joints
Soft Tissue
Mycosis Fungoides
Other Skin
Breast
Cervix
Corpus Uteri
Ovary
Other Female Genital
Prostate
Other Male Genital
Urinary Bladder
Kidney
Other Urinary
Eye and Orbit
Brain and Nervous System
Thyroid
Unknown Sites
Ill-Defined Sites
Other Endocrine System
Donors
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
Rotow, Julia, Kathleen
Site Research Nurses
Janell, Samantha
Kelley, Elaine
Lam, Ethan
Mcnally, Megan
Souza, Joseph
Sullivan, Molly, O'Brien

Trial Description

The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC in solid tumors

Eligibility Requirements

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed locally advanced
unresectable or metastatic solid tumor and have failed all 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), triple negative breast cancer (TNBC)
and soft tissue sarcoma (STS)

- 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 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 BA3021
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.

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