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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
Must not have
Pregnant or breastfeeding if female
History of significant cardiac disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new drug called TORL-1-23 in patients with advanced cancer to see if it is safe and effective. Researchers will study how the drug behaves in the body and its ability to fight cancer.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is in an advanced stage and not just in one place.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.
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I have a history of serious heart problems.
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I do not have any serious, uncontrolled illnesses or infections.
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I have a history of myelodysplastic syndrome or acute myeloid leukemia.
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My cancer has spread to my brain and is getting worse or causing symptoms.

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-1-23
+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 Finding - Part 1Experimental Treatment1 Intervention
TORL-1-23
Group II: Expansion as Monotherapy - Part 2Experimental Treatment1 Intervention
TORL-1-23

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies, immunotherapies, and chemotherapy. Targeted therapies, such as EGFR inhibitors (e.g., osimertinib) and ALK inhibitors (e.g., crizotinib), work by specifically targeting and inhibiting the activity of mutated proteins that drive cancer growth. Immunotherapies, like PD-1/PD-L1 inhibitors (e.g., pembrolizumab), enhance the immune system's ability to recognize and destroy cancer cells. Chemotherapy, using agents like cisplatin and pemetrexed, kills rapidly dividing cells, including cancer cells, by interfering with DNA replication. These treatments are crucial for NSCLC patients as they offer personalized and effective options to manage the disease, potentially improving survival and quality of life. The antitumor agent TORL-1-23, being studied for its safety and efficacy, likely represents a novel approach within these categories, aiming to provide additional therapeutic benefits.

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
5 Previous Clinical Trials
510 Total Patients Enrolled
Stephen Letrent, PharmD, PhDStudy DirectorTORL Biotherapeutics, LLC
6 Previous Clinical Trials
380 Total Patients Enrolled

Media Library

TORL-1-23 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05103683 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Monotherapy Dose Finding - Part 1, Expansion as Monotherapy - Part 2
Non-Small Cell Lung Cancer Clinical Trial 2023: TORL-1-23 Highlights & Side Effects. Trial Name: NCT05103683 — Phase 1
TORL-1-23 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05103683 — Phase 1
~22 spots leftby Nov 2025
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