What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy agents like carboplatin and paclitaxel can cause side effects such as nausea, fatigue, hair loss, and increased risk of infection. Targeted therapies, which focus on specific genetic mutations, may lead to skin rashes, diarrhea, and liver toxicity. Immunotherapies, such as pembrolizumab and nivolumab, can result in immune-related side effects including colitis, pneumonitis, and thyroid dysfunction. The antitumor agent TORL-1-23, being an investigational therapy, may have a unique side effect profile, but it is likely to share some common adverse effects with these established treatments.

What prior FDA approvals exist?

The FDA has approved several antitumor agents for the treatment of advanced Non-Small Cell Lung Cancer (NSCLC). Notable approvals include pembrolizumab and nivolumab, which are immune checkpoint inhibitors targeting PD-1, and atezolizumab, targeting PD-L1. These drugs have shown efficacy in improving overall survival and progression-free survival in patients with advanced NSCLC. Additionally, combinations of these immunotherapies with chemotherapy have been approved, such as pembrolizumab with carboplatin and paclitaxel. These treatments are similar to the investigational antitumor agent TORL-1-23, which is being studied for its safety, tolerability, and antitumor activity in advanced cancer.

What other types of research exist?

Promising novel alternatives to TORL-1-23 for NSCLC patients include: 1) Pembrolizumab, which has shown improved overall survival and progression-free survival in combination with chemotherapy for advanced NSCLC. 2) Nivolumab, which has demonstrated intracranial response in NSCLC patients with brain metastases. 3) Atezolizumab, which has shown safety and efficacy in advanced NSCLC patients with or without baseline brain metastases. 4) Lorlatinib, which has shown brain penetration and efficacy in ALK-positive NSCLC. 5) Alectinib, which has shown activity against systemic disease and brain metastases in ALK-rearranged NSCLC.

← Back to Search

Other

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

Select...

My cancer is in an advanced stage and not just in one place.

Select...

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:

Select...

I am not pregnant or breastfeeding.

Select...

I have a history of serious heart problems.

Select...

I do not have any serious, uncontrolled illnesses or infections.

Select...

I have a history of myelodysplastic syndrome or acute myeloid leukemia.

Select...

My cancer has spread to my brain and is getting worse or causing symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

0 / 7Eligibility criteria met

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.