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TORL-1-23 for Advanced Cancer (TRIO049 Trial)
Phase 1
Recruiting
Research Sponsored by TORL Biotherapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Advanced solid tumor
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
TRIO049 Trial Summary
This trial will test a new cancer drug to see if it is safe and works against tumors.
Who is the study for?
This trial is for adults with advanced solid tumors, including specific cancers like non-small cell lung cancer and ovarian cancer. Participants must have measurable disease, be relatively fit (ECOG status 0-1), and their organs must function well. They can't join if they have serious brain metastases, unresolved side effects from past treatments, recent other cancer therapies, severe health issues unrelated to the tumor, certain blood disorders or another recent cancer.Check my eligibility
What is being tested?
The study is testing TORL-1-23's safety and effectiveness in treating advanced cancers. It's a first-in-human study which means it's the first time this drug is being given to people. Researchers will look at how patients tolerate the drug, its behavior in the body (pharmacokinetics), and whether it shrinks tumors.See study design
What are the potential side effects?
Since TORL-1-23 is new and this is its first trial in humans, potential side effects are not fully known yet. However, common side effects of similar cancer drugs may include fatigue, nausea, allergic reactions or infusion-related reactions.
TRIO049 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is in an advanced stage and not just in one place.
Select...
I am fully active or can carry out light work.
TRIO049 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of adverse events and serious adverse events
Maximum Tolerated Dose (MTD)
Recommended Phase 2 Dose (RP2D)
Secondary outcome measures
1 Year Overall Survival (1YOS)
2 Year Overall Survival (2YOS)
Accumulation ratio (Rac) of TORL-1-23
+17 moreTRIO049 Trial Design
2Treatment groups
Experimental Treatment
Group I: Monotherapy Dose Finding - Part 1Experimental Treatment1 Intervention
TORL-1-23
Group II: Expansion as Monotherapy - Part 2Experimental Treatment1 Intervention
TORL-1-23
Find a Location
Who is running the clinical trial?
Translational Research in OncologyOTHER
21 Previous Clinical Trials
6,587 Total Patients Enrolled
TORL Biotherapeutics, LLCLead Sponsor
4 Previous Clinical Trials
280 Total Patients Enrolled
Stephen Letrent, PharmD, PhDStudy DirectorTORL Biotherapeutics, LLC
6 Previous Clinical Trials
380 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Monotherapy Dose Finding - Part 1
- Group 2: Expansion as Monotherapy - Part 2
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 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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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