First In Human Study Of TORL-2-307-ADC In Participants With Advanced Cancer

Study Overview

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

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-ADC in patients with advanced cancer

N/A

Advanced Solid Tumor
Gastric Cancer
Pancreas Cancer
Gastroesophageal Junction Adenocarcinoma

DRUG: TORL-2-307-ADC

TORL2307ADC-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-12-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-02
First Submitted that Met QC Criteria 2021-12-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-03
First Posted (ACTUAL) 2021-12-14	Results First Posted N/A	Last Verified 2024-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Monotherapy Dose Dose Finding - Part 1 TORL-2-307-ADC	DRUG: TORL-2-307-ADC antibody drug conjugate
EXPERIMENTAL: Expansion as Monotherapy - Part 2 TORL-2-307-ADC	DRUG: TORL-2-307-ADC antibody drug conjugate

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Monotherapy Dose Dose Finding - Part 1

TORL-2-307-ADC

DRUG: TORL-2-307-ADC

antibody drug conjugate

EXPERIMENTAL: Expansion as Monotherapy - Part 2

TORL-2-307-ADC

DRUG: TORL-2-307-ADC

antibody drug conjugate

Primary Outcome Measures	Measure Description	Time Frame
Incidence and severity of adverse events and serious adverse events	Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0	up to 2 years
Maximum Tolerated Dose (MTD)	Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants	28 Days
Recommended Phase 2 Dose (RP2D)	Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data	up to 2 years

Secondary Outcome Measures	Measure Description	Time Frame
Objective Response Rate (ORR)	Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1	up to 2 years
Duration of Response (DOR)	Time from CR or PR to objective disease progression or death to any cause	up to 2 years
Progression Free Survival (PFS)	PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause	up to 2 years
Time to Response (TTR)	Time from start of treatment to complete response or partial response	up to 2 years
1 Year Overall Survival (1YOS)	Proportion of participants alive at 1 year from the start of treatment to death from any cause	1 year
2 Year Overall Survival (2YOS)	Proportion of participants alive at 2 years from the start of treatment to death from any cause	2 years
Number of anti-drug antibody (ADA) Positive Participants	Immunogenicity will be measured by the number of participants that are ADA positive.	up to 2 years
Maximum Serum Concentration of TORL-2-307-ADC (Cmax)	PK assessment	21 days
Minimum Serum Concentration of TORL-2-307-ADC (Cmin)	PK assessment	21 days
Maximum Serum Concentration of TORL-2-307-ADC at Steady State (Cmax,ss)	PK assessment	63 days
Minimum Serum Concentration of TORL-2-307-ADC at Steady State (Cmin,ss)	PK assessment	63 days
Time of Maximum Serum Concentration of TORL-2-307-ADC (Tmax)	PK assessment	21 days
Time of Minimum Serum Concentration of TORL-2-307-ADC (Tmin)	PK Assessment	21 days
Time of Minimum Serum Concentration of TORL-2-307-ADC at Steady State (Tmin,ss)	PK Assessment	63 days
Terminal Half-life (t1/2) of Serum TORL-2-307-ADC	PK Assessment	63 days
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-2-307-ADC	PK Assessment	21 days
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-2-307-ADC	PK Assessment	63 days
Apparent volume of distribution during the terminal phase (Vz) of TORL-2-307-ADC	PK Assessment	63 days
Clearance (CL) of TORL-2-307-ADC	PK Assessment	63 days
Accumulation ratio (Rac) of TORL-2-307-ADC	PK Assessment	63 days

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Ibrahim Qazi, PharmD

Phone Number: 310-348-9636

Email: ibrahim.qazi@torlbio.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Advanced solid tumor
Measurable disease, per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Adequate organ function

Has not recovered [recovery is defined as NCI CTCAE, version 5.0, grade ≤1] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements
Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-2-307-ADC
Progressive or symptomatic brain metastases
Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
History of significant cardiac disease
History of myelodysplastic syndrome (MDS) or AML
History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded
If female, is pregnant or breastfeeding

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Translational Research in Oncology

Investigators

STUDY_CHAIR: Ibrahim Qazi, PharmD, TORL Biotherapeutics, LLC

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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