TORL-2-307-ADC for Gastroesophageal Junction Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Fort Wayne Medical Oncology and Hematology, Fort Wayne, INGastroesophageal Junction Adenocarcinoma+3 MoreTORL-2-307-ADC - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new cancer drug to see if it is safe and effective.

Eligible Conditions
  • Advanced Solid Tumors
  • Stomach Cancer
  • Pancreatic Cancer
  • Gastroesophageal Junction Adenocarcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 20 Secondary · Reporting Duration: 2 years

1 year
1 Year Overall Survival (1YOS)
2 years
2 Year Overall Survival (2YOS)
21 days
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-1-23
Maximum Serum Concentration of TORL-2-307-ADC (Cmax)
Minimum Serum Concentration of TORL-2-307-ADC (Cmin)
Time of Maximum Serum Concentration of TORL-2-307-ADC (Tmax)
Time of Minimum Serum Concentration of TORL-2-307-ADC (Tmin)
28 Days
Maximum Tolerated Dose (MTD)
63 days
Accumulation ratio (Rac) of TORL-2-307-ADC
Apparent volume of distribution during the terminal phase (Vz) of TORL-2-307-ADC
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-1-23
Clearance (CL) of TORL-2-307-ADC
Maximum Serum Concentration of TORL-2-307-ADC at Steady State (Cmax,ss)
Minimum Serum Concentration of TORL-2-307-ADC at Steady State (Cmin,ss)
Terminal Half-life (t1/2) of Serum TORL-2-307-ADC
Time of Minimum Serum Concentration of TORL-2-307-ADC at Steady State (Tmin,ss)
up to 2 years
Duration of Response (DOR)
Incidence and severity of adverse events and serious adverse events
Number of anti-drug antibody (ADA) Positive Participants
Objective Response Rate (ORR)
Progression Free Survival (PFS)
Recommended Phase 2 Dose (RP2D)
Time to Response (TTR)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Monotherapy Dose Dose Finding - Part 1
1 of 2
Expansion as Monotherapy - Part 2
1 of 2

Experimental Treatment

70 Total Participants · 2 Treatment Groups

Primary Treatment: TORL-2-307-ADC · No Placebo Group · Phase 1

Monotherapy Dose Dose Finding - Part 1
Drug
Experimental Group · 1 Intervention: TORL-2-307-ADC · Intervention Types: Drug
Expansion as Monotherapy - Part 2
Drug
Experimental Group · 1 Intervention: TORL-2-307-ADC · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

TORL Biotherapeutics, LLCLead Sponsor
2 Previous Clinical Trials
160 Total Patients Enrolled
Translational Research in OncologyOTHER
19 Previous Clinical Trials
6,789 Total Patients Enrolled
Stephen Letrent, PharmD, PhDStudy DirectorTORL Biotherapeutics, LLC
4 Previous Clinical Trials
334 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a type of cancer that has spread to other parts of your body.

Who else is applying?

What state do they live in?
California100.0%
How old are they?
65+100.0%
What site did they apply to?
UCLA - JCCC Clinical Research Unit100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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)." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.