Back to Clinical Trials

Brief Title: TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers

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

INTRODUCTION

  • Org Study ID: TTX-030-002
  • Secondary ID: N/A
  • NTC ID: NCT04306900
  • Sponsor: 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.


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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Adverse Events

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

CONDITION

  • Solid Tumor
  • Adult

ELIGIBILITY


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

Gender: All

Minimum Age: 110 Years

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: +1 888-480-0554

Email: clinicaltrials@trishulatx.com

LOCATION

Facility Status Contact
Facility: HonorHealth Research Institute
Scottsdale, Arizona 85258
United States
Status: Recruiting Contact:
Joyce Schaffer, RN
480-323-1791
clinicaltrials@honorhealth.com
Facility: City of Hope Medical Center Clinical Trials Office
Duarte, California 91010
United States
Status: Recruiting Contact:
Tina Zhang
626-218-0867
tizhang@coh.org
Facility: University of Southern California
Los Angeles, California 90007
United States
Status: Recruiting Contact:
Lorraine Martinez

Facility: Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
Status: Recruiting Contact:
Bethany Wendel, RN-BSN, CCRP
310-967-4339
cancer.trial.info@cshs.org
Facility: UCLA Hematology/Oncology
Los Angeles, California 90404
United States
Status: Recruiting Contact:
Lisa Yonemoto
310-633-8400
lyonemoto@mednet.ucla.edu
Facility: Chao Family Comprehensive CC, UCI
Orange, California 92868
United States
Status: Recruiting Contact:
General Contact
877-827-8839
ucstudy@uci.edu
Facility: UC Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Status: Recruiting Contact:
Corinne Turrell, CCRP
916-734-3089
ceturrell@ucdavis.edu
Facility: Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine
Miami, Florida 33136
United States
Status: Recruiting Contact:
Reisy Guedes, BS, CRC
305-243-8807
rxg957@med.miami.edu
Facility: Ocala Oncology Center PL
Ocala, Florida 34474
United States
Status: Recruiting Contact:
Sanjit Nirmalanandhan
352-547-1958
sanjit.nirmalanandhan@usoncology.com
Facility: Orlando Health UF Health Cancer Center
Orlando, Florida 32835
United States
Status: Recruiting Contact:
Karin Donaldson
321-841-9821
karin.donaldson@orlandohealth.com
Facility: IACT Health - John B. Amos Cancer Center
Columbus, Georgia 31904
United States
Status: Recruiting Contact:
Katrina Quidley, MHA, ACRP-CP
706-229-7439
kquidley@iacthealth.com
Facility: University of Chicago Medical Center
Chicago, Illinois 60637
United States
Status: Recruiting Contact:
Clinical Trial Recruitment

cancerclinicaltrials@bsd.uchicago.edu
Facility: Norton Cancer Institute
Louisville, Kentucky 40202
United States
Status: Recruiting Contact:
Research Department
502-629-2500
MISC-NCIResearch@nortonhealthcare.org
Facility: Ochsner Medical Center
New Orleans, Louisiana 70121
United States
Status: Recruiting Contact:
Sharon Jerdonek
504-842-3929
sharon.jerdonek@ochsner.org
Facility: Nebraska Cancer Center Oncology Hematology West P.C.
Omaha, Nebraska 68130
United States
Status: Recruiting Contact:
Megan Meays, M.A. CCRC
402-691-6971
mmeays@nebraskacancer.com
Facility: Montefiore Medical Center
Bronx, New York 10461
United States
Status: Recruiting Contact:
Mohammad Ghalib
718-405-8515
mhghalib@montefiore.org
Facility: University Hospitals Cleveland Medical Center
Cleveland, Ohio 44122
United States
Status: Recruiting Contact:
Cancer Information Services
800-641-2422
Facility: University of Toledo
Toledo, Ohio 43614
United States
Status: Recruiting Contact:
Jill Sholl
419-383-4553
jill.sholl@utoledo.edu
Facility: Prisma-Health Cancer Institute
Greenville, South Carolina 29605
United States
Status: Recruiting Contact:
Jane W McClain
864-455-3781
jmcclain@ghs.org
Facility: West Cancer Center and Research Institute
Germantown, Tennessee 38138
United States
Status: Recruiting Contact:
Amanda Fletcher
901-683-0055
afletcher@westclinic.com
Facility: Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Status: Recruiting Contact:
Referral Line
615-329-7478
Cann.researchreferrals@scresearch.net
Facility: NEXT Oncology
San Antonio, Texas 78229
United States
Status: Recruiting Contact:
Sarah Gomez
210-580-9521
sgomez@nextsat.com
Facility: Hunstman Cancer Intitute
Salt Lake City, Utah 84112
United States
Status: Recruiting Contact:
Hannah Conway
801-587-4021
hannah.conway@hci.utah.edu
Facility: Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
Status: Recruiting Contact:
Alexander Spira, MD
703-280-5390
alexander.spira@usoncology.com
Facility: Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Status: Recruiting Contact:
General Cancer Center Info
414-805-8900
cccto@mcw.edu
Facility: National Cancer Center
Seogu, Busan 49201
Korea, Republic of
Status: Recruiting Contact:
Sung Yong Oh
+82-51-240-2808
drosy@dau.ac.kr
Facility: National Cancer Center
Ilsandong-gu, Goyang-si, Gyeonggi-do 10408
Korea, Republic of
Status: Recruiting Contact:
Yongjun Cha
+82-31-920-1668
yongjuncha@ncc.re.kr
Facility: Seoul National University
Seongnam-si Bundan-gu, Kyunggi-do 13620
Korea, Republic of
Status: Recruiting Contact:
Keun-Wook Lee
+82-31-787-7037
imdoctor@snu.ac.kr
Facility: Samsung Medical Center
Gangnam-gu, Seoul 06351
Korea, Republic of
Status: Recruiting Contact:
Seung Tae Kim
+82-2-3410-0297
seungtae1.kim@samsung.com
Facility: Asan Medical Center
Songpa-gu, Seoul 05505
Korea, Republic of
Status: Recruiting Contact:
Yoon-Koo Kang
+82-2-3010-8771
ykkang@amc.seoul.kr