TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers
NCT ID: NCT03884556
Last Updated: 2025-07-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
56 participants
INTERVENTIONAL
2019-04-10
2023-09-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This trial will study the safety, tolerability, pharmacokinetics, and anti-tumor activity of TTX-030 as a single agent and in combination with an approved anti-PD-1 immunotherapy and standard chemotherapies.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
3-AP and Gemcitabine in Treating Patients With Advanced Solid Tumors or Lymphoma
NCT00293345
Study of Tisagenlecleucel in Combination With Pembrolizumab in r/r Diffuse Large B-cell Lymphoma Patients
NCT03630159
Study of SNX281 in Subjects With Advanced Solid Tumors and Lymphoma
NCT04609579
TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers
NCT04485013
A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies
NCT03329950
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1, Single Agent
TTX-030
TTX-030
Variable dose and schedule
Arm 2, Anti-PD-1 Combination
TTX-030 plus pembrolizumab
TTX-030
Variable dose and schedule
Pembrolizumab
Dose and schedule per standard of care
Arm 4, Chemotherapy Combination
TTX-030 plus gemcitabine plus nab-paclitaxel
TTX-030
Variable dose and schedule
Gemcitabine
Dose and schedule per standard of care
nab paclitaxel
Dose and schedule per standard of care
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TTX-030
Variable dose and schedule
Pembrolizumab
Dose and schedule per standard of care
Gemcitabine
Dose and schedule per standard of care
nab paclitaxel
Dose and schedule per standard of care
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* eligible to receive single-agent pembrolizumab as standard of care, or
* eligible to receive single-agent docetaxel as standard of care, or
* advanced pancreatic adenocarcinoma and eligible to receive gemcitabine plus nab-paclitaxel as standard of care.
2. Age 18 years or older, is willing and able to provide informed consent
3. Evidence of measurable disease
4. Life expectancy \> 12 weeks and Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Exclusion Criteria
2. Use of investigational agent within 28 days prior to the first dose of study treatment and throughout the study
3. Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
4. History of severe autoimmune disease
5. Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Trishula Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UC Irvine Cancer Center
Orange, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
University of California, San Francisco
San Francisco, California, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Nebraska Cancer Center Oncology Hematology West P.C.
Omaha, Nebraska, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Columbia University Irving Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
West Cancer Center and Research Institute
Germantown, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
NEXT Oncology
San Antonio, Texas, United States
Huntsman Cancer Intitute
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TTX-030-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.