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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 : May 3, 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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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: May 3, 2021
Last Verified: April 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