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
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an investigational drug called ORB-021 in people diagnosed with advanced solid tumors. The study aims to determine if ORB-021 is safe and tolerable and to find the best dose by assessing safety and potential activity. This is a phase 1 clinical trial sponsored by Orionis Biosciences Inc and includes three main phases: screening, treatment, and end of treatment. ORB-021 is a specially engineered biologic molecule that targets immune cells to activate cytokines in a way that may reduce side effects. It is given through intravenous infusion. Participants will receive the drug in escalating doses across multiple cohorts, starting from the lowest dose and increasing if no dose-limiting toxicities are observed. Up to five dose levels have been planned to identify the recommended dose for future studies. During the study, participants will undergo screening to confirm eligibility, followed by treatment with ORB-021 at assigned dose levels. Researchers will monitor participants for adverse events and assess safety over 12 months. They will also evaluate the recommended phase 2 dose based on safety and tolerability. Participants' organ function, performance status, and other health measures will be assessed at regular intervals throughout the study to ensure safety and collect data on how the drug affects solid tumors.
CONDITIONS
Brief 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 suitable for serial biopsies
- Received or are ineligible for all standard therapies as determined by your doctor
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate organ and marrow function based on blood tests and kidney function
- Negative pregnancy test for women of childbearing potential before treatment
- Willingness to use approved contraception methods during and 30 days after treatment
- Ability to understand and sign informed consent
You will not qualify if you...
- Currently receiving other investigational treatments
- Allergic reactions to drugs similar to ORB-021 or its components
- Uncontrolled illnesses such as active infections, heart failure, unstable angina, arrhythmia, or psychiatric conditions
- Pregnant or breastfeeding women
- Unresolved symptomatic hydronephrosis
- Recent anticancer therapy within 28 days or 5 half-lives before study treatment
- Other cancers diagnosed within 2 years except certain skin and localized cancers
- Untreated or symptomatic brain tumors or metastases
- Recent use of immunosuppressive medications except certain corticosteroids
- Active or prior autoimmune or inflammatory disorders requiring immunosuppressive therapy, with some exceptions
- History of primary immunodeficiency or organ transplant
- Hypersensitivity to interferon alpha 2b or excipients
- Active infections including tuberculosis, hepatitis B or C, HIV with low CD4 count, or COVID-19
- Recent live vaccination within 28 days
- Conditions interfering with study evaluation or safety
- Uncontrolled seizures
- Significant unresolved toxicity from previous cancer treatments
- QTcF interval greater than 480 ms
- Prior severe immune-related adverse events from PD-1 or PD-L1 treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive ORB-021 by intravenous infusion at escalating dose levels to evaluate safety and determine the recommended phase 2 dose.
Visits occur according to dosing schedule and safety assessments during treatment
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
A
Azza Gadir, PhD
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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