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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
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence and severity of adverse events and serious adverse events
Maximum Tolerated Dose (MTD)
Recommended Phase 2 Dose (RP2D)
Secondary study objectives
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
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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
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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.
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