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Brief Title: TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers

Phase 1/1b Study of the Safety of TTX-030 as a Single Agent and in Combination With Pembrolizumab or Chemotherapy in Patients With Lymphoma or Solid Tumor Malignancies

INTRODUCTION

  • Org Study ID: TTX-030-001
  • Secondary ID: N/A
  • NTC ID: NCT03884556
  • Sponsor: Trishula Therapeutics, Inc.

BRIEF SUMMARY


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.


  • Overall Status
    Recruiting
  • Start Date
    April 10, 2019
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Recommended Phase 2 Dose (RP2D)

Primary Outcome 1 - Timeframe: 1 cycle (each cycle is 21-28 days)

CONDITION

  • Solid Tumor
  • Lymphoma

ELIGIBILITY


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

Gender: All

Minimum Age: N/A

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: UC Irvine Cancer Center
Orange, California 92868
United States
Status: Recruiting Contact:
Dorothy Chang
714-509-2199
dorothc@hs.uci.edu
Facility: UC Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Status: Recruiting Contact:
Stacy Joo
916-734-4913
ssjoo@ucdavis.edu
Facility: University of California, San Francisco
San Francisco, California 94143
United States
Status: Recruiting Contact:
Cancer Immunotherapy program

HDFCCC.CIP@ucsf.edu
Facility: Sylvester Comprehensive Cancer Center
Miami, Florida 33136
United States
Status: Recruiting Contact:
Isabel Fernandez, CCRC
305-243-2647
i.fernandez6@med.miami.edu
Facility: Rush University Cancer Center
Chicago, Illinois 60612
United States
Status: Recruiting Contact:
Cancer Studies
312-CANCER-1
Facility: Norton Cancer Institute
Louisville, Kentucky 40202
United States
Status: Recruiting Contact:
Ben Orem
502-629-2500
ben.orem@nortonhealthcare.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: Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United States
Status: Recruiting Contact:
Olga Kovalenko
973-972-3173
kovaleoa@cinj.rutgers.edu
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: 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: Huntsman Cancer Intitute
Salt Lake City, Utah 84112
United States
Status: Recruiting Contact:
Ashley Leary, RN, BSN
801-213-8429
ashley.leary@hci.utah.edu