ORB-011 In Patients With Advanced Solid Tumors (ORB)
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ClinicalTrials.gov Identifier: NCT05947474 |
Recruitment Status :
Recruiting
First Posted : July 17, 2023
Last Update Posted : September 13, 2023
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Tracking Information | |||||||||
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First Submitted Date ICMJE | June 7, 2023 | ||||||||
First Posted Date ICMJE | July 17, 2023 | ||||||||
Last Update Posted Date | September 13, 2023 | ||||||||
Actual Study Start Date ICMJE | August 1, 2023 | ||||||||
Estimated Primary Completion Date | March 2025 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | ORB-011 In Patients With Advanced Solid Tumors | ||||||||
Official Title ICMJE | ORB-011 In Patients With Advanced Solid Tumors | ||||||||
Brief Summary | The goal of this clinical research study is to determine if an investigational new drug, named ORB-011, 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. |
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Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced Solid Cancer | ||||||||
Intervention ICMJE | Drug: ORB-011
Drug: ORB-011 is dosed via IV infusion
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Study Arms ICMJE | Experimental: Dose Escalation ORB-011
ORB-011 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 7 dose cohorts have been pre-specified. Doses from the escalation arms will be selected as RP2D candidates.
Intervention: Drug: ORB-011
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
36 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 2025 | ||||||||
Estimated Primary Completion Date | March 2025 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Patients are to be excluded from the study if they meet any of the following criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT05947474 | ||||||||
Other Study ID Numbers ICMJE | OR1-01 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Orionis Biosciences Inc | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Orionis Biosciences Inc | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Orionis Biosciences Inc | ||||||||
Verification Date | September 2023 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |