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TORL-1-23 for Advanced Cancer (TRIO049 Trial)
TRIO049 Trial Summary
This trial will test a new cancer drug to see if it is safe and works against tumors.
TRIO049 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTRIO049 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TRIO049 Trial Design
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Who is running the clinical trial?
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- I am not pregnant or breastfeeding.I still experience side effects from past treatments, except for hair loss or acceptable lab results.I have a history of serious heart problems.My organs are functioning well.I have not had cancer treatment within the trial's specified time.I do not have any serious, uncontrolled illnesses or infections.I have had cancer before, but it meets the trial's exception criteria.I have a history of myelodysplastic syndrome or acute myeloid leukemia.My cancer is in an advanced stage and not just in one place.I am fully active or can carry out light work.My cancer has spread to my brain and is getting worse or causing symptoms.
- Group 1: Monotherapy Dose Finding - Part 1
- Group 2: Expansion as Monotherapy - Part 2
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there any spots open for volunteers in this clinical trial?
"The study, which is currently looking for participants, was first posted on clinicaltrials.gov on 11/17/2021 and updated on 9/8/2022."
What is the FDA's stance on TORL-1-23?
"The TORL-1-23 intervention is still in early stages of testing, so it only received a score of 1 for safety."
What are the goals that researchers hope to achieve with this clinical trial?
"The primary outcome of this study, to be measured over the course of two years, is the Recommended Phase 2 Dose (RP2D). Additionally, researchers will also observe and take note of the Accumulation ratio (Rac) of TORL-1-23 , Time of Maximum Serum Concentration of TORL-1-23 (Tmax), and Maximum Serum Concentration of TORL-1-23 (Cmax) as secondary outcomes."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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