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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
No Placebo-Only Group

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 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
5 Previous Clinical Trials
530 Total Patients Enrolled
Stephen Letrent, PharmD, PhDStudy DirectorTORL Biotherapeutics, LLC
6 Previous Clinical Trials
400 Total Patients Enrolled

Media Library

TORL-3-600 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05948826 — Phase 1
Colorectal Cancer Research Study Groups: Monotherapy Dose Dose Finding - Part 1, Expansion as Monotherapy - Part 2
Colorectal Cancer Clinical Trial 2023: TORL-3-600 Highlights & Side Effects. Trial Name: NCT05948826 — Phase 1
TORL-3-600 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05948826 — Phase 1
~24 spots leftby Sep 2025
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