ORB-011 In Patients With Advanced Solid Tumors (ORB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05947474|
Recruitment Status : Recruiting
First Posted : July 17, 2023
Last Update Posted : September 13, 2023
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.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Cancer||Drug: ORB-011||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ORB-011 In Patients With Advanced Solid Tumors|
|Actual Study Start Date :||August 1, 2023|
|Estimated Primary Completion Date :||March 2025|
|Estimated Study Completion Date :||June 2025|
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.
Drug: ORB-011 is dosed via IV infusion
- Number of Adverse Events (AE) in patients dosed with ORB-011 [ Time Frame: 12 months ]Number of participants with adverse events (AE) in patients dosed with ORB-011
- Determine Recommended Phase 2 Dose (RP2D) [ Time Frame: 12 months ]Identify a RP2D for future studies.
- Measure Maximum Plasma Concentration [Cmax]). [ Time Frame: 12 months ]Measure Maximum Plasma Concentration [Cmax]) of ORB-011 in patients
- Collect the number of Dose Limiting Toxicities (DLTs) in patients dosed with ORB-001 [ Time Frame: 12 months ]Record the number of DLTs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05947474
|Contact: Jennifer Hertzog, PhDfirstname.lastname@example.org|
|Contact: Azza Gadir, PhDemail@example.com|
|United States, Arizona|
|Honor Health Research Institute||Recruiting|
|Scottsdale, Arizona, United States, 85258|
|Contact: Muhammad R Khawaja, MD 480-323-1350 firstname.lastname@example.org|
|Contact: Nidhi Sheth, BSN 480-583-7208 email@example.com|
|Principal Investigator: Muhammad R Khawaja, MD|
|United States, Texas|
|MD Anderson Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Apostolia Tsimberidou, MD PhD 713-792-4259 firstname.lastname@example.org|
|Contact: Debbie Stroughter 713-792-7734 CR_study_registration@mdanderson.org|
|Principal Investigator: Apostolia Tsimberidou, MD|
|Study Chair:||Robert Petit, PhD||SVP Early Clinical Development|