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

INTRODUCTION

Org Study ID: TTX-030-002
Secondary ID: N/A
NTC ID: NCT04306900
Sponsor: Trishula Therapeutics, Inc.

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 Outcome 1 - Measure: Adverse Events

Primary Outcome 1 - Timeframe: 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
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

Name: N/A

Role: N/A

Affiliation: N/A

Name: N/A

Phone: +1 888-480-0554

Email: clinicaltrials@trishulatx.com

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

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

BRIEF SUMMARY

PRIMARY OUTCOMES

CONDITION

ELIGIBILITY

OFFICIAL INFORMATION

Overall Contact

LOCATION

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