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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03884556
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 8, 2021
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Solid Tumor Lymphoma Drug: TTX-030 Drug: Pembrolizumab Drug: Docetaxel Drug: Gemcitabine Drug: nab paclitaxel Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Arm 1, Single Agent
Drug: TTX-030
Variable dose and schedule

Experimental: Arm 2, Anti-PD-1 Combination
TTX-030 plus pembrolizumab
Drug: TTX-030
Variable dose and schedule

Drug: Pembrolizumab
Dose and schedule per standard of care

Experimental: Arm 3, Chemotherapy Combination
TTX-030 plus docetaxel
Drug: TTX-030
Variable dose and schedule

Drug: Docetaxel
Dose and schedule per standard of care

Experimental: Arm 4, Chemotherapy Combination
TTX-030 plus gemcitabine plus nab-paclitaxel
Drug: TTX-030
Variable dose and schedule

Drug: Gemcitabine
Dose and schedule per standard of care

Drug: nab paclitaxel
Dose and schedule per standard of care

Primary Outcome Measures :
  1. Recommended Phase 2 Dose (RP2D) [ Time Frame: 1 cycle (each cycle is 21-28 days) ]
    Assess the safety profile, dose limiting toxicity (DLT), maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of TTX-030 when administered intravenously (IV) as a single agent and in combination with agents in specified regimens to subjects with advanced solid tumor malignancies or lymphoma

Secondary Outcome Measures :
  1. Anti-tumor activity [ Time Frame: Through study completion, an average of 1 year ]
    Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens

  2. Maximum Plasma Concentration (Cmax) [ Time Frame: Cycles 1-3 (each cycle is 21-28 days) ]
    Pharmacokinetics (PK) of TTX-030

  3. CD39 Expression [ Time Frame: Through study completion, an average of 1 year ]
    Pharmacodynamic (PD) biomarkers relating to mechanism of action and immune responses

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03884556

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Contact: Trishula Therapeutics, Inc. +1 888-480-0554

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United States, California
UC Irvine Cancer Center Recruiting
Orange, California, United States, 92868
Contact: Dorothy Chang    714-509-2199   
UC Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Stacy Joo    916-734-4913   
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Cancer Immunotherapy program   
United States, Florida
Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Isabel Fernandez, CCRC    305-243-2647   
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40202
Contact: Ben Orem    502-629-2500 ext 19471   
Contact: Pamela Adkisson, RN    502-629-2500 ext 19460   
United States, Nebraska
Nebraska Cancer Center Oncology Hematology West P.C. Recruiting
Omaha, Nebraska, United States, 68130
Contact: Megan Meays, M.A. CCRC    402-691-6971   
United States, New Jersey
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Olga Kovalenko    973-972-3173   
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Mohammad Ghalib    718-405-8515   
Contact: Sanjay Goel, MD    718-405-8404   
Columbia University Irving Medical Center Recruiting
New York, New York, United States, 10032
Contact: Lisa Olmos    212-342-5162   
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Maggie Reynolds    646-888-4404   
Contact: Erin Fredericksen    646-888-4440   
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44122
Contact: Cancer Information Services    800-641-2422      
United States, Pennsylvania
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Abigail Kessler    412-623-3793   
United States, Tennessee
West Cancer Center and Research Institute Recruiting
Germantown, Tennessee, United States, 38138
Contact: Amanda Fletcher    901-683-0055   
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Referral Line    615-329-7478   
United States, Texas
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: Cynthia De Leon    210-580-9521   
United States, Utah
Huntsman Cancer Intitute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Ashley Leary, RN, BSN    801-213-8429   
Sponsors and Collaborators
Trishula Therapeutics, Inc.
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Responsible Party: Trishula Therapeutics, Inc. Identifier: NCT03884556    
Other Study ID Numbers: TTX-030-001
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 8, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Trishula Therapeutics, Inc.:
Metastatic Solid Tumors
Advanced Solid Tumors
Relapsed/Refractory Lymphoma
Prostrate Cancer
Pancreatic Cancer
Combination Therapy
Adenosine Pathway
Checkpoint Inhibitor
Bladder Cancer
Lung Cancer
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological