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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have adequate hepatic function based on specific criteria
Participants must have adequate renal function based on specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)
Awards & highlights
Study Summary
This trial is testing a new drug, TT-10, to see if it is safe and effective for people with advanced solid tumors. The first part of the trial will test different doses to see what the maximum tolerated dose is.
Who is the study for?
Adults with advanced solid tumors like oral, head and neck, kidney, prostate or lung cancer who've not responded to standard treatments can join. They must have a life expectancy over 3 months, good blood and organ function, and be able to consent. Some need accessible tumors for biopsies.Check my eligibility
What is being tested?
The trial is testing TT-10's safety when taken orally by patients with certain advanced cancers. It aims to find the highest dose patients can tolerate without severe side effects (MTD) or the suggested dose for future Phase 2 trials (RP2D).See study design
What are the potential side effects?
Specific side effects of TT-10 are not listed but generally may include typical reactions to cancer medications such as nausea, fatigue, risk of infection due to low blood counts, liver issues or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver is functioning well.
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My kidney function is within normal ranges.
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I am 18 years old or older.
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My cancer is confirmed and advanced.
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My advanced lung cancer has not responded to or is not suitable for standard treatments.
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I have kidney cancer that has spread and standard treatments haven't worked or I can't receive them.
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I have RCC, CRPC, or NSCLC and cannot receive standard treatments.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Define the maximum tolerated dose (MTD) or phase 2 recommended dose of TT-10 during the dose escalation phase
Expansion cohort primary objective - safety
Number of subjects with Dose Limiting Toxicities (DLTs) of TT-10 during the dose escalation phase
Secondary outcome measures
Area under the serum concentration versus time curve (AUC) of TT-10
Duration of Response (DoR)
Half-life of TT-10
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Multiple Ascending DoseExperimental Treatment1 Intervention
3+3 Dose escalation until MTD and/or R2PD of TT-10 is determined
Find a Location
Who is running the clinical trial?
Portage BiotechLead Sponsor
Tarus Therapeutics, Inc.Industry Sponsor
1 Previous Clinical Trials
69 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver is functioning well.I have not had radiotherapy in the last 2 weeks.My kidney function is within normal ranges.I have a history of hepatitis C.I have not had any cancer treatment in the last 4 weeks.I am 18 years old or older.I have RCC, CRPC, or NSCLC, can't get standard treatment, and my tumor can be biopsied.I have had a peptic ulcer or gastrointestinal bleed in the last 6 months.I am not pregnant or breastfeeding.My cancer is confirmed and advanced.I have metastatic prostate cancer and standard treatments haven't worked or I can't receive them.My cancer can be measured by scans and has grown in previously treated areas.I need medication to suppress my immune system.You have a positive hepatitis B surface antigen test without meeting certain requirements.I do not have any active cancer except for non-dangerous skin cancer, early-stage cervical or prostate cancer.I do not have any severe uncontrolled health conditions.My advanced lung cancer has not responded to or is not suitable for standard treatments.Your blood needs to be healthy based on certain standards.I haven't had a stroke, heart attack, or severe heart rhythm problems in the last 6 months.I have had lung conditions that needed steroid treatment.You have HIV.I need to take certain medications for my condition.I do not have any ongoing serious infections.I have not received a live vaccine in the last 6 weeks.I have had surgery or issues with my digestive system that could affect how drugs work in my body.I have kidney cancer that has spread and standard treatments haven't worked or I can't receive them.Your heart's electrical activity (QT interval) is longer than normal.You are expected to live for at least 3 more months.I have not had major surgery in the last 4 weeks.I have RCC, CRPC, or NSCLC and cannot receive standard treatments.I will provide a fresh tissue sample before treatment and agree to a biopsy during treatment.My cancer has spread to my brain.I am fully active or can carry out light work.My condition did not improve with standard treatments, or there are no suitable treatments available.
Research Study Groups:
This trial has the following groups:- Group 1: Multiple Ascending Dose
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.
Are there any current openings for participants in this research?
"The clinical trial in question is not currently active, as evidenced by the lack of recent updates on the website (the last update was on April 26th, 2022) and the original posting date of August 15th, 2022. Although this particular study is not looking for patients at the moment, there are 1057 other trials that are open for enrollment."
Answered by AI
What is the aim of this clinical trial?
"The aim of this study, which will take up to a year, is to monitor the number of Dose Limiting Toxicities (DLTs) during the dose escalation phase. Additionally, researchers are looking at secondary objectives including the Peak serum concentration (Cmax), Area under the serum concentration versus time curve (AUC), and Half-life of TT-10 - all defined as PK Parameters."
Answered by AI
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