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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

Condition:

  • Solid Tumor, Adult

Eligibility

Criteria:
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
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: 110 Years

Healthy Volunteers: No

Overall Contact

Name: Trishula Therapeutics, Inc.

Phone: +1 888-480-0554

Email: clinicaltrials@trishulatx.com

Locations

Facility Status Contact
HonorHealth Research Institute
Scottsdale, Arizona 85258
United States
Recruiting Joyce Schaffer, RN
480-323-1791
clinicaltrials@honorhealth.com
City of Hope Medical Center Clinical Trials Office
Duarte, California 91010
United States
Recruiting Tina Zhang
626-218-0867
tizhang@coh.org
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
310-967-4339
cancer.trial.info@cshs.org
UCLA Hematology/Oncology
Los Angeles, California 90404
United States
Recruiting Lisa Yonemoto
310-633-8400
lyonemoto@mednet.ucla.edu
Chao Family Comprehensive CC, UCI
Orange, California 92868
United States
Recruiting General Contact
877-827-8839
ucstudy@uci.edu
UC Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Recruiting Corinne Turrell, CCRP
916-734-3089
ceturrell@ucdavis.edu
Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine
Miami, Florida 33136
United States
Recruiting Reisy Guedes, BS, CRC
305-243-8807
rxg957@med.miami.edu
Ocala Oncology Center PL
Ocala, Florida 34474
United States
Recruiting Sanjit Nirmalanandhan
352-547-1958
sanjit.nirmalanandhan@usoncology.com
Orlando Health UF Health Cancer Center
Orlando, Florida 32835
United States
Recruiting Karin Donaldson
321-841-9821
karin.donaldson@orlandohealth.com
IACT Health - John B. Amos Cancer Center
Columbus, Georgia 31904
United States
Recruiting Katrina Quidley, MHA, ACRP-CP
706-229-7439
kquidley@iacthealth.com
University of Chicago Medical Center
Chicago, Illinois 60637
United States
Recruiting Clinical Trial Recruitment

cancerclinicaltrials@bsd.uchicago.edu
Norton Cancer Institute
Louisville, Kentucky 40202
United States
Recruiting Research Department
502-629-2500
MISC-NCIResearch@nortonhealthcare.org
Ochsner Medical Center
New Orleans, Louisiana 70121
United States
Recruiting Sharon Jerdonek
504-842-3929
sharon.jerdonek@ochsner.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
Montefiore Medical Center
Bronx, New York 10461
United States
Recruiting Mohammad Ghalib
718-405-8515
mhghalib@montefiore.org
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44122
United States
Recruiting Cancer Information Services
800-641-2422
University of Toledo
Toledo, Ohio 43614
United States
Recruiting Jill Sholl
419-383-4553
jill.sholl@utoledo.edu
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
864-455-3781
jmcclain@ghs.org
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 Sarah Gomez
210-580-9521
sgomez@nextsat.com
Hunstman Cancer Intitute
Salt Lake City, Utah 84112
United States
Recruiting Hannah Conway
801-587-4021
hannah.conway@hci.utah.edu
Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
Recruiting Alexander Spira, MD
703-280-5390
alexander.spira@usoncology.com
Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Recruiting General Cancer Center Info
414-805-8900
cccto@mcw.edu
National Cancer Center
Seogu, Busan 49201
Korea, Republic of
Recruiting Sung Yong Oh
+82-51-240-2808
drosy@dau.ac.kr
National Cancer Center
Ilsandong-gu, Goyang-si, Gyeonggi-do 10408
Korea, Republic of
Recruiting Yongjun Cha
+82-31-920-1668
yongjuncha@ncc.re.kr
Seoul National University
Seongnam-si Bundan-gu, Kyunggi-do 13620
Korea, Republic of
Recruiting Keun-Wook Lee
+82-31-787-7037
imdoctor@snu.ac.kr
Samsung Medical Center
Gangnam-gu, Seoul 06351
Korea, Republic of
Recruiting Seung Tae Kim
+82-2-3410-0297
seungtae1.kim@samsung.com
Asan Medical Center
Songpa-gu, Seoul 05505
Korea, Republic of
Recruiting Yoon-Koo Kang
+82-2-3010-8771
ykkang@amc.seoul.kr