Actively Recruiting
ORB-021 In Patients With Advanced Solid Tumors
Led by Orionis Biosciences Inc · Updated on 2026-02-10
36
Participants Needed
2
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical research study is to determine if an investigational new drug, named ORB-021, developed by Orionis Biosciences is safe and can be tolerated in people diagnosed with an advanced solid tumor. The study also aims to find the biologically optimal dose of the study medicine by assessing the safety and potential activity in the treatment of solid tumors. There are three phases to this study: screening, treatment and end of treatment.
CONDITIONS
Official Title
ORB-021 In Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with recurrent or refractory solid tumors safe for serial biopsies
- Received or ineligible for all standard care therapies as judged by treating physician
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate organ and marrow function including hemoglobin ≥ 9.0 g/dL, ANC ≥ 1.5 x 10^9/L, platelet count ≥ 75 x 10^9/L, bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), AST/ALT ≤ 2.5 x ULN without liver metastases or ≤ 5 x ULN with liver metastases, creatinine clearance > 40 mL/min
- Women of childbearing potential must have a negative pregnancy test within 3 days before treatment
- Patients and partners must use approved contraception during and for 30 days after treatment
- Ability to understand and sign informed consent
You will not qualify if you...
- Receiving any other investigational agents
- History of allergic reactions to ORB-021 or similar compounds
- Uncontrolled active illnesses including severe infections, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric illness limiting study compliance
- Pregnant or breastfeeding women
- Unresolved symptomatic hydronephrosis
- Any anticancer therapy within 28 days or 5 half-lives before study treatment
- Diagnosis of another malignancy within 2 years except certain localized or cured cancers
- Primary malignant brain tumors or untreated symptomatic brain metastases
- Use of immunosuppressive medication within 28 days before treatment except certain corticosteroids
- Active or prior autoimmune or inflammatory disorders requiring systemic immunosuppression with specific exceptions
- History of primary immunodeficiency or organ transplant
- History of hypersensitivity to interferon alpha 2b or excipients
- Active infections including tuberculosis, hepatitis B or C, HIV with low CD4 count or recent AIDS-defining infection, or SARS-COV2 positive
- Receipt of live attenuated vaccine within 28 days before treatment
- Any condition interfering with study evaluation or safety
- Uncontrolled seizures
- Unresolved toxicity grade ≥ 2 from prior anticancer therapy except specified exceptions
- QTcF interval > 480 ms
- Prior severe immune-related adverse events leading to discontinuation of PD-1 or PD-L1 therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Honor Health Clinical Research
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
MDAC
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jennifer Hertzog, PhD
CONTACT
A
Azza Gadir, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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