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Trial Title:
A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer
NCT ID:
NCT06005740
Condition:
Advanced Solid Tumor
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma, Hepatocellular
Conditions: Keywords:
ADC
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TORL-4-500
Description:
antibody drug conjugate
Arm group label:
Expansion as Monotherapy - Part 2
Arm group label:
Monotherapy Dose Dose Finding - Part 1
Summary:
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and
antitumor activity of TORL-4-500 in patients with advanced cancer.
For Part 1, any advanced or metastatic solid tumor malignancy will be evaluated
including, for example, adrenocortical carcinoma (ACC).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Advanced solid tumor
- Measurable disease, per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function
Exclusion Criteria:
- 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-4-500
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Providence Medical Foundation
Address:
City:
Fullerton
Zip:
92835
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yung Lyou, MD
Facility:
Name:
UCLA - JCCC Clinical Research Unit
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lee Rosen, MD
Phone:
310-829-5471
Facility:
Name:
Torrance Memorial Physician Network
Address:
City:
Torrance
Zip:
90505
Country:
United States
Status:
Recruiting
Contact:
Last name:
Justin Tiulim, MD
Investigator:
Last name:
Justin Tiulim, MD
Email:
Principal Investigator
Facility:
Name:
University Health Network, Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Erica Tsang
Investigator:
Last name:
Erica Tsang
Email:
Principal Investigator
Facility:
Name:
McGill University Health Centre
Address:
City:
Montréal
Zip:
H4A 3J1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Ramy Saleh, MD
Investigator:
Last name:
Ramy Saleh, MD
Email:
Principal Investigator
Start date:
December 4, 2023
Completion date:
October 31, 2026
Lead sponsor:
Agency:
TORL Biotherapeutics, LLC
Agency class:
Industry
Collaborator:
Agency:
Translational Research in Oncology
Agency class:
Other
Source:
TORL Biotherapeutics, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06005740
