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QBI-139 for Advanced Cancer
Phase 1
Waitlist Available
Research Sponsored by Quintessence Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >18 years
ECOG performance status <2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycles 1 and 2 (six weeks)
Awards & highlights
Study Summary
This trial is designed to find the maximum tolerated dose of QBI-139 in patients with advanced, refractory solid tumors.
Who is the study for?
This trial is for adults over 18 with advanced solid tumors that no longer respond to standard treatments. They must have measurable tumor growth, be in relatively good health (ECOG <2), and have normal organ/marrow function. Participants should not be pregnant or trying to conceive and must understand the study's consent form. Prior cancer treatments are okay if enough time has passed.Check my eligibility
What is being tested?
The trial tests QBI-139, given through IV once a week for three weeks in cycles of 21 days, continuing unless there's disease progression or severe side effects. The goal is to find the highest dose patients can take without serious side effects by gradually increasing doses among small groups.See study design
What are the potential side effects?
Potential side effects include reactions related to the infusion process, toxicity affecting various organs due to high drug doses, and general discomforts like fatigue or digestive issues which are common with cancer therapies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
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I can do most of my daily activities without help.
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My organ and bone marrow functions are normal.
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I am not pregnant, breastfeeding, or planning to conceive during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycle 1 (three weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 (three weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate the toxicity and tolerability of and the maximum tolerated dose for QBI-139 in patients with advanced refractory solid tumors.
Secondary outcome measures
To determine the patient response rate to QBI-139 using the RECIST criteria.
To evaluate the pharmacokinetics of QBI-139
Find a Location
Who is running the clinical trial?
Quintessence Biosciences, Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently in another clinical trial or haven't been in one for the last 4 weeks.I have not fully recovered from my previous surgeries.I have cancer that has spread to my brain or the lining around my brain.I have a weakened immune system or have had an organ transplant.I haven't had a heart attack or new chest pain in the last 6 months.I've had chemotherapy or radiation, but any major side effects are now minimal.I am older than 18 years.I can do most of my daily activities without help.I am being treated with Ranpirnase (Onconase®).I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My organ and bone marrow functions are normal.I am not pregnant, breastfeeding, or planning to conceive during the study.I haven't had a serious GI bleed or severe diarrhea recently.I am not pregnant or breastfeeding.My condition hasn't improved with standard treatments.
Research Study Groups:
This trial has the following groups: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.
Has this therapy gained the sanction of regulatory bodies?
"The treatment's safety has been rated a 1, as this is just the initial Phase 1 trial and there are only scant amounts of data that indicate efficacy or security."
Answered by AI
Are there still positions available to join this research project?
"The clinicaltrials.gov website confirms that this medical trial is no longer actively recruiting participants; the original post was published on January 1st 2009 and the most recent edit occurred on January 27th 2015. However, 449 alternative trials are seeking volunteers at present."
Answered by AI
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