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

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ClinicalTrials.gov Identifier: NCT03884556
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
Trishula Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE March 16, 2019
First Posted Date  ICMJE March 21, 2019
Last Update Posted Date May 3, 2021
Actual Study Start Date  ICMJE April 10, 2019
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • 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
  • Maximum Plasma Concentration (Cmax) [ Time Frame: Cycles 1-3 (each cycle is 21-28 days) ]
    Pharmacokinetics (PK) of TTX-030
  • CD39 Expression [ Time Frame: Through study completion, an average of 1 year ]
    Pharmacodynamic (PD) biomarkers relating to mechanism of action and immune responses
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor
  • Lymphoma
Intervention  ICMJE
  • Drug: TTX-030
    Variable dose and schedule
  • Drug: Pembrolizumab
    Dose and schedule per standard of care
  • Drug: Docetaxel
    Dose and schedule per standard of care
  • Drug: Gemcitabine
    Dose and schedule per standard of care
  • Drug: nab paclitaxel
    Dose and schedule per standard of care
Study Arms  ICMJE
  • Experimental: Arm 1, Single Agent
    TTX-030
    Intervention: Drug: TTX-030
  • Experimental: Arm 2, Anti-PD-1 Combination
    TTX-030 plus pembrolizumab
    Interventions:
    • Drug: TTX-030
    • Drug: Pembrolizumab
  • Experimental: Arm 3, Chemotherapy Combination
    TTX-030 plus docetaxel
    Interventions:
    • Drug: TTX-030
    • Drug: Docetaxel
  • Experimental: Arm 4, Chemotherapy Combination
    TTX-030 plus gemcitabine plus nab-paclitaxel
    Interventions:
    • Drug: TTX-030
    • Drug: Gemcitabine
    • Drug: nab paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Trishula Therapeutics, Inc. +1 888-480-0554 clinicaltrials@trishulatx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03884556
Other Study ID Numbers  ICMJE TTX-030-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Trishula Therapeutics, Inc.
Study Sponsor  ICMJE Trishula Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Trishula Therapeutics, Inc.
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP