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Monoclonal Antibodies

TORL-4-500 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 study a drug's safety, effectiveness, and how it moves through the body in people with advanced cancer.

Who is the study for?

This trial is for adults with advanced solid tumors, including liver cancer, who have measurable disease and are in good physical condition (ECOG 0-1). They must have proper organ function and not be recovering from severe side effects of previous treatments. People with brain metastases, significant heart issues, recent cancer therapies, uncontrolled diseases or infections, a history of certain blood disorders or another cancer within the last three years cannot join.Check my eligibility

What is being tested?

The study tests TORL-4-500 to see how safe it is and how well it works against advanced cancers. It will also look at how the body processes the drug. This is an early-phase trial designed to gather initial data on this new potential treatment's effects on people with serious forms of cancer.See study design

What are the potential side effects?

Since TORL-4-500 is being tested for the first time in humans, specific side effects are unknown but may include typical reactions seen with other cancer drugs such as nausea, fatigue, allergic reactions or more serious complications affecting organs which will be closely monitored.

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

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-4-500

+17 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Monotherapy Dose Dose Finding - Part 1Experimental Treatment1 Intervention

TORL-4-500 iv once every 3 weeks

Group II: Expansion as Monotherapy - Part 2Experimental Treatment1 Intervention

TORL-4-500 iv once every 3 weeks

Do I qualify?Apply below to find out

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment actively recruiting participants?

"Clinicaltrials.gov reveals that this medical investigation is not currently enrolling participants, with the initial posting on October 31st 2023 and the last update occuring in August of 2023. Despite this trial's lack of availability for candidacy, there are still 1178 other studies actively searching for volunteers at present."

Answered by AI

What is the safety profile of Monotherapy Dose Dose Finding - Part 1 for participants?

"Our in-house experts assigned Monotherapy Dose Finding - Part 1 a score of 1, as it is only at the Phase 1 stage and thus has limited data illustrating its safety and efficacy."

Answered by AI

What is the desired outcome of this trial?

"The primary objective of this research is to identify the Maximum Tolerated Dose (MTD). Secondary endpoints include Duration of Response (DOR), Progression Free Survival (PFS) and Time to Response (TTR). This trial's duration will span approximately two years."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer

2023. "A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06005740.