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BRIEF TITLE: TTX-030 (Anti-CD39) in Combination With Pembrolizumab or Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors

Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Pembrolizumab or Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors

  • Org Study ID: TTX-030-002
  • Secondary ID:
  • NCT ID: NCT04306900
  • NCT Alias:
  • Sponsor: Trishula Therapeutics, Inc. - Industry
  • Source: Trishula Therapeutics, Inc.

Brief Summary

This is a phase 1/1b study of TTX-030 in combination therapy, 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, pharmacodynamics and anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard chemotherapies.

Overal Status Start Date Phase Study Type
Recruiting March 30, 2020 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Adverse Events

Primary Outcome 1 - Time Frame: Through study completion, an average of 1 year


  • Solid Tumor, Adult


Abbreviated Inclusion Criteria:

1. Age 18 years or older, is willing and able to provide informed consent

2. Histologically confirmed diagnosis of unresectable or metastatic solid tumor
malignancy in selected tumor types

3. Life expectancy > 12 weeks

4. 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

4. History of severe autoimmune disease

5. Uncontrolled intercurrent illness or other active malignancy requiring ongoing
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Gender: All

Minimum Age: 18 Years

Maximum Age: 110 Years

Healthy Volunteers: No

Overall Contact

Name: Trishula Therapeutics, Inc.

Phone: +1 888-480-0554



Facility Status Contact
HonorHealth Research Institute
Scottsdale, Arizona 85258
United States
Recruiting Joyce Schaffer, RN
City of Hope Medical Center Clinical Trials Office
Duarte, California 91010
United States
Recruiting Tina Zhang
University of Southern California
Los Angeles, California 90007
United States
Recruiting Lorraine Martinez

Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
Recruiting Bethany Wendel, RN-BSN, CCRP
UCLA Hematology/Oncology
Los Angeles, California 90404
United States
Recruiting Lisa Yonemoto
Chao Family Comprehensive CC, UCI
Orange, California 92868
United States
Recruiting General Contact
UC Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Recruiting Corinne Turrell, CCRP
Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine
Miami, Florida 33136
United States
Recruiting Reisy Guedes, BS, CRC
Ocala Oncology Center PL
Ocala, Florida 34474
United States
Recruiting Sanjit Nirmalanandhan
Orlando Health UF Health Cancer Center
Orlando, Florida 32835
United States
Recruiting Karin Donaldson
IACT Health - John B. Amos Cancer Center
Columbus, Georgia 31904
United States
Recruiting Katrina Quidley, MHA, ACRP-CP
University of Chicago Medical Center
Chicago, Illinois 60637
United States
Recruiting Clinical Trial Recruitment
Norton Cancer Institute
Louisville, Kentucky 40202
United States
Recruiting Research Department
Ochsner Medical Center
New Orleans, Louisiana 70121
United States
Recruiting Sharon Jerdonek
Nebraska Cancer Center Oncology Hematology West P.C.
Omaha, Nebraska 68130
United States
Recruiting Megan Meays, M.A. CCRC
Montefiore Medical Center
Bronx, New York 10461
United States
Recruiting Mohammad Ghalib
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44122
United States
Recruiting Cancer Information Services
University of Toledo
Toledo, Ohio 43614
United States
Recruiting Jill Sholl
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Active, not recruiting
Prisma-Health Cancer Institute
Greenville, South Carolina 29605
United States
Recruiting Jane W McClain
West Cancer Center and Research Institute
Germantown, Tennessee 38138
United States
Recruiting Amanda Fletcher
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Recruiting Referral Line
NEXT Oncology
San Antonio, Texas 78229
United States
Recruiting Sarah Gomez
Hunstman Cancer Intitute
Salt Lake City, Utah 84112
United States
Recruiting Hannah Conway
Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
Recruiting Alexander Spira, MD
Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Recruiting General Cancer Center Info
National Cancer Center
Seogu, Busan 49201
Korea, Republic of
Recruiting Sung Yong Oh
National Cancer Center
Ilsandong-gu, Goyang-si, Gyeonggi-do 10408
Korea, Republic of
Recruiting Yongjun Cha
Seoul National University
Seongnam-si Bundan-gu, Kyunggi-do 13620
Korea, Republic of
Recruiting Keun-Wook Lee
Samsung Medical Center
Gangnam-gu, Seoul 06351
Korea, Republic of
Recruiting Seung Tae Kim
Asan Medical Center
Songpa-gu, Seoul 05505
Korea, Republic of
Recruiting Yoon-Koo Kang