ORB-021 In Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumors Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOrionis Biosciences Inc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
ORB-021
DrugORB-021 is dosed via IV infusion
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: Experimental: Dose Escalation ORB-021Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
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
Time frame
12 monthsSecondary outcomes
1
Determine Recommended Phase 2 Dose (RP2D)
Identify a RP2D for future studies.
Time frame
12 monthsOther outcomes
1
Collect the number of Dose Limiting Toxicities (DLTs) in patients dosed with ORB-021
Record the number of DLTs
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov