RecruitingAdvanced Solid Tumors Cancer
ORB-021 In Patients With Advanced Solid Tumors
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
See if you qualify for this study
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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.
Sponsor: Orionis Biosciences Inc
You may qualify if…
- ✓ All patients must meet the following criteria for inclusion:
- ✓ 1. Age 18 years or older
- ✓ 2. Patients with evidence of recurrent or refractory solid tumors deemed medically safe to undergo serial biopsies.
- ✓ 3. Must have received or be ineligible for all standard of care therapies as deemed appropriate by the treating physician.
- ✓ 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- ✓ 5. Adequate organ and marrow function as defined below:
- ✓ Hemoglobin ≥ 9.0 g/dL
- ✓ Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (\> 1500 per mm3)
You may not qualify if…
- ✕ Patients are to be excluded from the study if they meet any of the following criteria:
- ✕ 1. Patients who are receiving any other investigational agents
- ✕ 2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ORB-021 or its excipients.
- ✕ 3. 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.
- ✕ 4. 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.
- ✕ 5. Patients with unresolved symptomatic hydronephrosis.
- ✕ 6. 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
- ✕ 7. 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
Where it's recruiting
Source: ClinicalTrials.gov · NCT06607939 · last updated 2026-02-10