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Trial record 1 of 1 for:    TTX-030-001
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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884556
Recruitment Status : Active, not recruiting
First Posted : March 21, 2019
Last Update Posted : April 12, 2023
Sponsor:
Information provided by (Responsible Party):
Trishula Therapeutics, Inc.

Study Description
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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: Gemcitabine Drug: nab paclitaxel Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 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
Actual Primary Completion Date : November 30, 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1, Single Agent
TTX-030
 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 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


Outcome Measures
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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


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

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03884556


Locations
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United States, California
UC Irvine Cancer Center
Orange, California, United States, 92868
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Florida
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Kentucky
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
United States, Nebraska
Nebraska Cancer Center Oncology Hematology West P.C.
Omaha, Nebraska, United States, 68130
United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Columbia University Irving Medical Center
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44122
United States, Pennsylvania
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
West Cancer Center and Research Institute
Germantown, Tennessee, United States, 38138
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
NEXT Oncology
San Antonio, Texas, United States, 78229
United States, Utah
Huntsman Cancer Intitute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Trishula Therapeutics, Inc.
More Information
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Responsible Party: Trishula Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03884556    
Other Study ID Numbers: TTX-030-001
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: April 12, 2023
Last Verified: April 2023
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.:
Cancer
Metastatic Solid Tumors
Advanced Solid Tumors
Relapsed/Refractory Lymphoma
Prostrate Cancer
Pancreatic Cancer
Monotherapy
Combination Therapy
CD39
Adenosine Pathway
 Immunotherapy
Immuno-oncology
PD-1
Checkpoint Inhibitor
Nab-paclitaxel
Gemcitabine
Pembrolizumab
Docetaxel
Bladder Cancer
Lung Cancer
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Paclitaxel
Gemcitabine
Pembrolizumab
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors