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Monoclonal Antibodies
TORL-3-600 for Advanced Cancer
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will examine the safety and effectiveness of a new cancer drug in patients with advanced cancer.
Who is the study for?
This trial is for adults with advanced solid tumors, measurable disease, good performance status (able to carry out daily activities), and proper organ function. It's not for those who've had recent cancer treatments, have serious health issues or infections, a history of certain blood disorders or another cancer within the last 3 years (except some skin cancers and low-risk cases). Pregnant or breastfeeding women and individuals with significant heart disease or active brain metastases are also excluded.Check my eligibility
What is being tested?
The study tests TORL-3-600 in patients with advanced cancers to assess its safety, how well it's tolerated by the body, how the body processes it (pharmacokinetics), and its effectiveness against tumors. As this is a first-in-human study, participants will be among the first to receive this experimental treatment.See study design
What are the potential side effects?
Since TORL-3-600 is being tested for the first time in humans, potential side effects are unknown but may include typical reactions seen with other cancer therapies such as nausea, fatigue, allergic reactions or more serious complications depending on how it affects different organs.
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-3-600
+17 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Monotherapy Dose Dose Finding - Part 1Experimental Treatment1 Intervention
TORL-3-600
Group II: Expansion as Monotherapy - Part 2Experimental Treatment1 Intervention
TORL-3-600
Find a Location
Who is running the clinical trial?
Translational Research in OncologyOTHER
21 Previous Clinical Trials
6,607 Total Patients Enrolled
TORL Biotherapeutics, LLCLead Sponsor
4 Previous Clinical Trials
300 Total Patients Enrolled
Stephen Letrent, PharmD, PhDStudy DirectorTORL Biotherapeutics, LLC
6 Previous Clinical Trials
400 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious, uncontrolled illnesses or infections.I still experience side effects from past treatments, except for hair loss or acceptable lab results.I have not taken any cancer treatments recently before starting TORL-3-600.I am not pregnant or breastfeeding.I have had cancer before, but it was either a certain skin cancer or a low-risk type.My organs are working well.I have a history of serious heart problems.I am fully active or can carry out light work.I have a history of myelodysplastic syndrome or acute myeloid leukemia.My cancer is in an advanced stage and not just in one place.My brain cancer is getting worse or causing symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Monotherapy Dose 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.
What aims are the researchers attempting to attain through this clinical experiment?
"The primary goal of this clinical trial, which will take up to two years, is determine the Maximum Tolerated Dose (MTD). Secondary objectives include assessing Duration of Response (DOR), Progression Free Survival (PFS) and Time to Response (TTR)."
Answered by AI
Is there still an opportunity for potential participants to join this experiment?
"According to clinicaltrials.gov, the last update for this particular trial was posted on July 9th 2023 and it is no longer recruiting patients. Nonetheless, there are still over 1600 medical trials currently seeking candidates at present time."
Answered by AI
How reliable is the Monotherapy Dose Finding - Part 1 regimen for patient safety?
"Taking into account the limited safety and efficacy data, our team at Power has rated Monotherapy Dose Finding - Part 1 with a score of 1 on their scale."
Answered by AI
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