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ORB-021 for Advanced Solid Tumors

This study is testing a new drug called ORB-021 for people with advanced solid tumors (cancers that form in solid organs). The main goals are to see if ORB-021 is safe and how well your body tolerates it. Researchers also want to find the best dose of ORB-021 and see if it has any positive effects on your tumor. ORB-021 is given through an IV (intravenous) infusion. You may be able to join if you are 18 or older, have a solid tumor that has come back or is not responding to standard treatments, and your doctor thinks it's safe for you to have biopsies. The study is currently recruiting about 36 participants.

Study design
This study is testing ORB-021 in people with advanced solid tumors. It aims to enroll about 36 participants.
What's involved
The study has three phases: screening, treatment, and end of treatment. You would receive ORB-021 through IV infusions.
Compensation
Not stated in the trial record.
Follow-up
The study will measure adverse events (side effects) for 12 months after you receive ORB-021.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06607939

ORB-021 In Patients With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Orionis Biosciences Inc
~36 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:ORB-021

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Adverse Events (AE) in patients dosed with ORB-021 Number of participants with adverse events (AE) in patients dosed with ORB-011
Measured over 12 months

Conditions

Advanced Solid Tumors Cancer

Explore related trials

Solid Neoplasm

NCT06607939

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Honor Health Clinical Research

    Scottsdale, Arizonastudy coordinator listed

    Recruiting

  • MDAC

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Robert Petit, PhD · STUDY_CHAIR · Orionis Biosciences

Who to contact

Jennifer Hertzog, PhD
[email protected]
617-204-8836
Email the study team

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Eligibility criteria

Inclusion

Hemoglobin ≥ 9.0 g/dL
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (\> 1500 per mm3)
Platelet count ≥ 75 × 109/L (\> 75,000 per mm\^3)
Serum bilirubin less than or equal to 1.5 × institutional upper limit of normal (ULN).
AST (SGOT)/ALT (SGPT) less than or equal to 2.5 × institutional ULN for patients without known liver metastases and up to 5 x institutional ULN for patients with known liver metastases.
Creatinine clearance (CL) \> 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976)
Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 3 days prior to treatment. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal (at least 12 consecutive months with no menses without an alternative medical cause) 6. Patients and their partners must practice approved forms of contraception. Sexually active WCBP must agree to use a highly effective method of contraception prior to study entry and continuing for 30 days after ORB-021 administration. Highly effective methods of contraception are highly effective birth control methods with a failure rate of \< 1% per year when used consistently and correctly. Additionally, male patients should refrain from donating sperm for 3 months following the last dose of study drug. 7. Ability to understand and willingness to sign an Institutional Review Board (IRB)-approved written informed consent document.

Exclusion

Patients are to be excluded from the study if they meet any of the following criteria:
Patients with vitiligo or alopecia
Patients with hypothyroidism stable on hormonal replacement
Patients without active disease in the last 5 years may be included
Patients with celiac disease controlled by diet alone 11. History of primary immunodeficiency 12. History of allogeneic organ transplant 13. History of hypersensitivity to interferon alpha 2b or any excipient 14. Active infection with:
Tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and PPD testing if indicated),
Hepatitis B (HBV) or hepatitis C Virus (HBC): Patients with active HBV infection or active HCV infection are ineligible. However, patients with a history of HBV infection who have undetectable or low levels of HBV DNA and normal ALT are eligible. Patients with chronic HBV infection who meet the criteria for anti-HBV therapy are eligible if they have initiated anti-HBV therapy prior to treatment with ORB-021. Patients with a history of HCV infection are eligible if they have completed curative antiviral treatment and have a viral load that is below the limit of detection.
HIV: Patients living with HIV infection are ineligible only if they have a CD4 count less than 350 cells/µL and a history of an AIDS-defining infection within the last 12 months. Patients with a CD4 count greater than 350 cells/µL or who have not had an AIDS-defining infection within the last 12 months are eligible. Eligible patients living with HIV should maintain effective anti-retroviral therapy.
SARS-COV2 (PCR positive) 15. Receipt of live attenuated vaccination within 28 days prior to the study treatment 16. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results. 17. Patients with uncontrolled seizures

What this trial measures

  • Number of Adverse Events (AE) in patients dosed with ORB-021 Number of participants with adverse events (AE) in patients dosed with ORB-01112 months

    Number of participants with adverse events (AE) in patients dosed with ORB-021