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Advanced Solid Tumors CancerPhase 1OR2-01NCT06607939

ORB-021 In Patients With Advanced Solid Tumors

A Phase 1 study testing ORB-021 in people with Advanced Solid Tumors Cancer, run by Orionis Biosciences Inc at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors Cancer
What is being tested?
ORB-021
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesUnited States
Study dates
21 Nov 2024to May 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients must meet the following criteria for inclusion:
  • Age 18 years or older
  • Patients with evidence of recurrent or refractory solid tumors deemed medically safe to undergo serial biopsies.
  • Must have received or be ineligible for all standard of care therapies as deemed appropriate by the treating physician.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Adequate organ and marrow function as defined below:
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  • 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)
  • 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.
  • Ability to understand and willingness to sign an Institutional Review Board (IRB)-approved written informed consent document.

Who cannot join

  • Patients are to be excluded from the study if they meet any of the following criteria:
  • Patients who are receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to ORB-021 or its excipients.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Urinary tract infections (UTIs) are excluded from being an exclusion criterion for treatment unless they are Grade 3 or higher.
  • Pregnant women are excluded from this study because the effects of ORB-021 on a pregnant woman or fetus are unknown. Breastfeeding should be discontinued as the potential risk for AEs in nursing infants treated with ORB-021 is unknown.
  • Patients with unresolved symptomatic hydronephrosis.
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  • Any other anticancer therapy (eg, chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine therapy, radiation therapy, intravesical therapy, investigational agent) within 28 days or 5 half-lives (whichever is shorter) of the study treatment
  • The patient has a diagnosis of another malignancy within 2 years before the first dose of study treatment, except for superficial skin cancer, localized prostate cancer on active surveillance, or localized solid tumors deemed cured by surgery and not treated with systemic anticancer therapy and not expected to require anticancer therapy in the next 2 years
  • Patients with primary malignant brain tumors, untreated and/or unresolved or symptomatic brain metastasis
  • Current or prior use of immunosuppressive medication within 28 days before ORB-021 treatment with the exceptions of ophthalmic, intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
  • Active or prior documented autoimmune or inflammatory disorders requiring systemic immunosuppressive medications (including inflammatory bowel disease [eg. colitis or Crohn s disease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:
  • 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
  • History of primary immunodeficiency
  • History of allogeneic organ transplant
  • History of hypersensitivity to interferon alpha 2b or any excipient
  • 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)
  • Receipt of live attenuated vaccination within 28 days prior to the study treatment
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
  • Patients with uncontrolled seizures
  • Any unresolved toxicity National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, endocrinopathies, and the laboratory values defined in the inclusion criteria.
  • Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with ORB-021 may be included only after consultation with the Principal Investigator
  • Patients with QTcF \> 480 ms
  • Patients with prior grade 3 irAE or any irAE that resulted in discontinuation of PD-1 or PD-L1 ICI treatment.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jennifer Hertzog, PhD contact

617-204-8836

jhertzog@orionisbio.com

Azza Gadir, PhD contact

agadir@orionisbio.com

United States2 sites, 2 recruiting

  • MDAC

    Houston, Texas, 77030

    Aung Naing, MD, anaing@mdanderson.org

    Ashabari Sprenger, PhD, 713-834-6993, amukherjee1@mdanderson.org

    Recruiting

  • Honor Health Clinical Research

    Scottsdale, Arizona, 85258

    Justin Moser, MD Associate Clinical Investigator, HonorHealth, MD, 480-583-7219, jmoser@honorhealth.com

    Justin Moser, MD Associate Clinical Investigator, HonorHealth, MD

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

ORB-021 is a complex engineered biologic molecule that targets cytokine activation specifically to certain immune cells which may have benefit in solid tumors. The cytokine in ORB-021 is inactive to cells expressing the receptor but confers full activity to individual cells when also bound to the target, thereby markedly reducing the potential for toxicities caused by the cytokine. ORB-021 is administered by intravenous (IV) infusion/injection.

Being tested
ORB-021
Keywords
cancer, solid tumors, adults
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ORB-021Drug

    ORB-021 is dosed via IV infusion

Study groups in NCT06607939
Study groupRoleWhat they receive
Experimental: Dose Escalation ORB-021ExperimentalORB-012 Dose Escalation Participants will be administered study drug at dose levels corresponding to their Cohort. Cohort 1 will be treated with the lowest dose, and the dose will be escalated for future cohorts once the previous dose has been observed not to be associated with DLTs. Up to 5 dose cohorts have been pre-specified. Doses from the escalation arms will be selected as RP2D candidates.
Receives: Drug: ORB-021

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Adverse Events (AE) in patients dosed with ORB-021 Number of participants with adverse events (AE) in patients dosed with ORB-011

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

    Measured: 12 months

Secondary outcomes (1)

  1. Determine Recommended Phase 2 Dose (RP2D)

    Identify a RP2D for future studies.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2024
  2. Study start21 Nov 2024
  3. Primary completion29 Jan 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Experimental: Dose Escalation ORB-021 ORB-021 Dose Escalation Participants will be administered study drug at dose levels corresponding to their Cohort. Cohort 1 will be treated with the lowest dose, and the dose will be escalated for future cohorts 5 dose cohorts have been pre-specified. Doses from the escalation arms will be selected as RP2D candidates. Drug: ORB-021 is dosed via IV infusion
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06607939
Sponsor's protocol ID
ORB-021
Other IDs
IND#167998
Acronym
OR2-01
Status last verified
Aug 2026
First submitted
19 Sep 2024
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ORB-021 in people with Advanced Solid Tumors Cancer, run by Orionis Biosciences Inc at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer Hertzog, PhD (617-204-8836, jhertzog@orionisbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Adverse Events (AE) in patients dosed with ORB-021 Number of participants with adverse events (AE) in patients dosed with ORB-011 (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06607939.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.

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