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Antibody-drug conjugate

TORL-2-307-ADC 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 test a new cancer drug to see if it is safe and effective.

Who is the study for?
This trial is for adults with advanced solid tumors, including specific cancers of the stomach and pancreas. Participants must have measurable disease, be relatively fit (ECOG status 0-1), and have good organ function. They can't join if they've had recent cancer treatments, unresolved side effects from past therapies (except hair loss or certain lab abnormalities), brain metastases, serious heart conditions, other active cancers within the last 3 years (with some exceptions), or are pregnant/breastfeeding.Check my eligibility
What is being tested?
The study is testing TORL-2-307-ADC's safety and effectiveness against advanced cancers. It's a first-in-human trial meaning it's the first time this drug is being tested in people to see how well it works and how safe it is.See study design
What are the potential side effects?
Since this is a first-in-human study of TORL-2-307-ADC, potential side effects aren't fully known yet but may include typical reactions to cancer drugs such as nausea, fatigue, allergic reactions to the medication infusion itself, blood count changes increasing infection risk.

Eligibility Criteria

Inclusion Criteria

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

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

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-ADC
+17 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Monotherapy Dose Dose Finding - Part 1Experimental Treatment1 Intervention
TORL-2-307-ADC
Group II: Expansion as Monotherapy - Part 2Experimental Treatment1 Intervention
TORL-2-307-ADC

Find a Location

Who is running the clinical trial?

TORL Biotherapeutics, LLCLead Sponsor
4 Previous Clinical Trials
300 Total Patients Enrolled
Translational Research in OncologyOTHER
21 Previous Clinical Trials
6,607 Total Patients Enrolled
Stephen Letrent, PharmD, PhDStudy DirectorTORL Biotherapeutics, LLC
6 Previous Clinical Trials
400 Total Patients Enrolled

Media Library

TORL-2-307-ADC (Antibody-drug conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT05156866 — 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-ADC Highlights & Side Effects. Trial Name: NCT05156866 — Phase 1
TORL-2-307-ADC (Antibody-drug conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05156866 — Phase 1

Frequently Asked Questions

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

Are potential patients able to enroll in this experiment at the moment?

"Affirmatively, this clinical trial is actively recruiting patients. Initially posted on February 2nd 2022 and recently updated on the 10th of that same month, all necessary information can be found hosted on clinicaltrials.gov."

Answered by AI

Has the Food and Drug Administration accepted TORL-2-307-ADC for use in humans?

"Due to the early stage nature of this trial, TORL-2-307-ADC received a score of 1 in terms of safety. This is because there are only limited data points illustrating its efficacy and lack thereof concerning its security."

Answered by AI

What outcomes is this investigation attempting to realize?

"This clinical trial, evaluated over a two-year period, aims to determine the Maximum Tolerated Dose (MTD) of an unnamed medication. Secondary objectives include determining Area under the Serum Concentration-Time curve from dosing time until infinity (AUCinf), 1 Year Overall Survival rate (1YOS), and Apparent volume of distribution during terminal phase (Vz)."

Answered by AI

How many individuals have been accepted into this clinical experiment?

"Yes, the details listed on clinicaltrials.gov demonstrate that this medical experiment is still recruiting. This research was initially posted on 2/2/2022 and has been revised as recently as 2/10/2022 - they are aiming to include 70 patients at a single location."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
65+
What site did they apply to?
UCLA - JCCC Clinical Research Unit
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer
2022. "First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05156866.
~16 spots leftby Jan 2025
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