This is a phase 1/1b study of TTX-030, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response. 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.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | April 10, 2019 | Phase 1 | Interventional |
Primary Outcome 1 - Measure: Recommended Phase 2 Dose (RP2D)
Primary Outcome 1 - Time Frame: 1 cycle (each cycle is 21-28 days)
Criteria:
Abreviated Inclusion Criteria
1. Advanced solid tumor malignancy or relapsed/refractory lymphoma, or
- 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
Abbreviated Exclusion Criteria
1. History of allergy or hypersensitivity to study treatment components. Patients with a
history of severe hypersensitivity reaction to any monoclonal antibody.
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
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Trishula Therapeutics, Inc.
Phone: +1 888-480-0554
Email: clinicaltrials@trishulatx.com
Facility | Status | Contact |
---|---|---|
UC Irvine Cancer Center Orange, California 92868 United States |
Recruiting |
Dorothy Chang 714-509-2199 dorothc@hs.uci.edu |
UC Davis Comprehensive Cancer Center Sacramento, California 95817 United States |
Recruiting |
Stacy Joo 916-734-4913 ssjoo@ucdavis.edu |
University of California, San Francisco San Francisco, California 94143 United States |
Recruiting |
Cancer Immunotherapy program HDFCCC.CIP@ucsf.edu |
Sylvester Comprehensive Cancer Center Miami, Florida 33136 United States |
Recruiting |
Isabel Fernandez, CCRC 305-243-2647 i.fernandez6@med.miami.edu |
Norton Cancer Institute Louisville, Kentucky 40202 United States |
Recruiting |
Ben Orem 502-629-2500 ben.orem@nortonhealthcare.org |
Nebraska Cancer Center Oncology Hematology West P.C. Omaha, Nebraska 68130 United States |
Recruiting |
Megan Meays, M.A. CCRC 402-691-6971 mmeays@nebraskacancer.com |
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey 08903 United States |
Recruiting |
Olga Kovalenko 973-972-3173 kovaleoa@cinj.rutgers.edu |
Montefiore Medical Center Bronx, New York 10461 United States |
Recruiting |
Mohammad Ghalib 718-405-8515 mhghalib@montefiore.org |
Columbia University Irving Medical Center New York, New York 10032 United States |
Recruiting |
Lisa Olmos 212-342-5162 cancerclinicaltrials@cumc.columbia.edu |
Memorial Sloan Kettering Cancer Center New York, New York 10065 United States |
Recruiting |
Maggie Reynolds 646-888-4404 reynoldm@mskcc.org |
University Hospitals Cleveland Medical Center Cleveland, Ohio 44122 United States |
Recruiting |
Cancer Information Services 800-641-2422 |
UPMC Hillman Cancer Center Pittsburgh, Pennsylvania 15232 United States |
Recruiting |
Abigail Kessler 412-623-3793 monacoa2@upmc.edu |
West Cancer Center and Research Institute Germantown, Tennessee 38138 United States |
Recruiting |
Amanda Fletcher 901-683-0055 afletcher@westclinic.com |
Sarah Cannon Research Institute Nashville, Tennessee 37203 United States |
Recruiting |
Referral Line 615-329-7478 Cann.researchreferrals@scresearch.net |
NEXT Oncology San Antonio, Texas 78229 United States |
Recruiting |
Cynthia De Leon 210-580-9521 cdeleon@nextoncology.com |
Huntsman Cancer Intitute Salt Lake City, Utah 84112 United States |
Recruiting |
Ashley Leary, RN, BSN 801-213-8429 ashley.leary@hci.utah.edu |