STEALTH-001A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
VET3-TGI
+ Pembrolizumab
Squamous Cell Carcinoma of Head and Neck+43
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: September 16, 2024
Actual date on which the first participant was enrolled.This clinical trial focuses on testing a new treatment called VET3-TGI for people with advanced solid tumors. The study aims to find out the safest and most effective dose of VET3-TGI when given alone or alongside another drug called pembrolizumab. VET3-TGI is specially designed in the lab to target and destroy cancer cells while sparing healthy ones. This new approach is important because it could offer a new way to treat cancers that have not responded well to other treatments. Participants in the study receive VET3-TGI either through direct injection into their tumors or by intravenous infusion. The study involves several groups to determine how much of VET3-TGI can be safely given on its own and in combination with pembrolizumab. Once the best dose is identified, more patients may receive that dose to further assess how well it works. This approach helps ensure that the treatment is both safe and potentially effective in fighting the cancer.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Key Inclusion Criteria: * Have pathologically confirmed, advanced, unresectable, or metastatic solid tumors. Preferred indications include, but are not limited to, breast carcinoma, bladder carcinoma, cervical squamous carcinoma, colorectal carcinoma, esophageal carcinoma, head and neck squamous carcinoma, renal cell carcinoma, ovarian carcinoma, sarcoma, thymoma, and uterine carcinoma. * Failed, intolerant to, or refused potentially curative treatment options, including but not limited to, standard of care molecularly targeted agents, immunotherapy (e.g., anti -pembrolizumab/PDL1 antibodies), and chemotherapy * Measurable disease as per RECIST 1.1 criteria * At least one tumor amenable to safe ITu injections and/or biopsies * ECOG performance status 0 or 1 * Demonstrate adequate organ function * Must be willing to comply with all protocol procedures and adhere to post-treatment care instructions Additional Inclusion criteria exist Key Exclusion Criteria: * Prior systemic therapy washout (dependent upon the therapy) * Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections. * CNS metastases and/or carcinomatous meningitis that have not been completely resected or completely irradiated. * Prior history of myocarditis * Known HIV/AIDS, active HBV or HCV infection. * Receiving high dose immunosuppressive medication or has a significant immunodeficiency (e.g. transplant recipient, etc). Additional Exclusion criteria exist
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 7 locations
USC/Norris Comprehensive Cancer Center
Los Angeles, United StatesOpen USC/Norris Comprehensive Cancer Center in Google MapsUC Irvine Health
Orange, United StatesUniversity of Miami
Miami, United StatesCommunity Health Network
Indianapolis, United States