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ORB-011 for Advanced Cancer (ORB Trial)
Phase 1
Recruiting
Research Sponsored by Orionis Biosciences Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
ORB Trial Summary
This trial will evaluate the safety and tolerability of a new drug to treat advanced solid tumors. Three phases will be studied to find the optimal dose.
Who is the study for?
Adults with advanced solid tumors who have tried or are ineligible for standard treatments can join this trial. They must be in good physical condition (ECOG 0-1), have proper organ and marrow function, and not be pregnant. Participants should agree to use effective contraception during the study.Check my eligibility
What is being tested?
The trial is testing ORB-011, a new drug by Orionis Biosciences, for safety and optimal dosing in treating various advanced solid tumors. The study includes screening, treatment phases, and follows up at the end of treatment.See study design
What are the potential side effects?
While specific side effects of ORB-011 aren't listed here, common ones from cancer drugs include fatigue, nausea, diarrhea, blood count changes increasing infection risk; however individual experiences may vary.
ORB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine Recommended Phase 2 Dose (RP2D)
Number of Adverse Events (AE) in patients dosed with ORB-011
Secondary outcome measures
Collect the number of Dose Limiting Toxicities (DLTs) in patients dosed with ORB-001
Measure Maximum Plasma Concentration [Cmax]).
ORB Trial Design
1Treatment groups
Experimental Treatment
Group I: Dose Escalation ORB-011Experimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Orionis Biosciences IncLead Sponsor
Robert Petit, PhDStudy ChairSVP Early Clinical Development
1 Previous Clinical Trials
39 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I can join even if I have a UTI, as long as it's not severe.I have a lasting side effect that won't worsen with ORB-011, as confirmed by the lead researcher.I am a woman who can have children and have a recent negative pregnancy test.I haven't taken strong immune system suppressing drugs in the last 28 days, except for low-dose steroids or nasal/inhaled corticosteroids.I have hydronephrosis not caused by my current cancer.I have or had an autoimmune or inflammatory disorder.I have seizures that are not controlled by medication.I am 18 years old or older.My kidneys work well enough to clear waste, with a creatinine clearance over 40 mL/min.I have not received a live vaccine in the last 28 days.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I haven't had any cancer besides skin, prostate, or cured localized tumors in the past 2 years.I have a type of cancer that is difficult to treat and safe for biopsy.I do not have active TB, Hepatitis B or C, HIV, or COVID-19.I don't have lasting side effects from cancer treatment, except for hair loss or skin changes.I've had or can't have all standard treatments my doctor recommends.My organs and bone marrow are working well.I haven't had any cancer treatments in the last 28 days or 5 half-lives, whichever is shorter.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation ORB-011
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree might patients be at risk when exposed to Dose Escalation ORB-011?
"Our assessment of ORB-011's safety rating is 1 as this drug is in its early stages, with only limited data regarding both efficacy and risk."
Answered by AI
What is the current enrollment capacity for this trial?
"Affirmative, clinicaltrials.gov attests that this trial is presently recruiting participants. This medical trial was first published on August 1st 2023 and its details were most recently updated on the 9th of the same month. 36 people need to be enrolled from a single site for successful completion of the study."
Answered by AI
Are there vacancies within this research study for participants?
"Affirmative. According to the clinical trials database, this medical study began being advertised on August 1st 2023 and is still recruiting participants as of today. The trial needs 36 patients from a single centre."
Answered by AI
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