← Back to Search

Monoclonal Antibodies

TORL-2-307-MAB 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

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Advanced solid tumor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will study a new drug for safety and how well it works in people with advanced cancer.

Who is the study for?

This trial is for adults with advanced solid tumors, including pancreatic, stomach, and gastroesophageal junction adenocarcinoma. Participants must have measurable disease and be in good physical condition (ECOG 0-1). They can't join if they've had certain blood cancers, untreated brain metastases, unresolved toxic effects from past treatments (except hair loss), recent cancer therapies within the last 14 to 28 days depending on the therapy type, serious health issues or infections, are pregnant/breastfeeding, have significant heart disease or another cancer within the last three years.Check my eligibility

What is being tested?

The study tests a new drug called TORL-2-307-MAB for safety and effectiveness against advanced cancers. It's a first-in-human study which means it's the first time this drug is being tried in people. The trial will also look at how the body processes the drug and its impact on tumor size.See study design

What are the potential side effects?

Since this is a first-in-human study of TORL-2-307-MAB for advanced cancers, potential side effects are not yet fully known but may include typical reactions related to immune-based therapies such as fatigue, nausea, inflammation-related symptoms or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or can carry out light work.

Select...

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

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-2-307-MAB

+17 more

Trial Design

2Treatment groups

Experimental Treatment

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

TORL-2-307-MAB

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

TORL-2-307-MAB

0 / 2Eligibility criteria met

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

Media Library

TORL-2-307-MAB (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05159440 — Phase 1

Gastroesophageal Junction Adenocarcinoma Research Study Groups: Monotherapy Dose Dose Finding - Part 1, Expansion as Monotherapy - Part 2

Gastroesophageal Junction Adenocarcinoma Clinical Trial 2023: TORL-2-307-MAB Highlights & Side Effects. Trial Name: NCT05159440 — Phase 1

TORL-2-307-MAB (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05159440 — Phase 1

Frequently Asked Questions

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

What key outcomes is this research seeking to uncover?

"According to the TORL Biotherapeutics, LLC clinical trial sponsor, Maximum Tolerated Dose (MTD) will be measured as a primary outcome over two years. Additionally, Objective Response Rate (ORR), Minimum Serum Concentration of TORL-2-307-MAB (Cmin), and Time of Maximum Serum Concentration of TORL-2-307-MAB (Tmax) are being assessed as secondary outcomes for this research study."

Answered by AI

What is the maximum capacity for subjects in this clinical investigation?

"Affirmative. The clinical trial is presently enlisting patients, with 70 slots available at 1 location; the original posting was on January 20th 2022 and data has been recently updated on January 24th 2022 according to information hosted by clinicaltrials.gov."

Answered by AI

Are patients still capable of enrolling in this experiment?

"According to the clinicaltrials.gov listing, this trial is continuing recruitment efforts which began on January 20th, 2022 and was last updated four days later on January 24th."

Answered by AI

To what degree is TORL-2-307-MAB hazardous to patient health?

"Due to its preliminary testing stages, TORL-2-307-MAB's safety is estimated at a score of 1. This assessment was made with reference to the limited evidence supporting both efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

First in Human Study of TORL-2-307-MAB in Participants With Advanced Cancer

2022. "First in Human Study of TORL-2-307-MAB in Participants With Advanced Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05159440.