Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects 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.
 
ClinicalTrials.gov Identifier: NCT04306900
Recruitment Status : Recruiting
First Posted : March 13, 2020
Last Update Posted : June 19, 2020
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Tizona Therapeutics, Inc

Tracking Information
First Submitted Date  ICMJE March 4, 2020
First Posted Date  ICMJE March 13, 2020
Last Update Posted Date June 19, 2020
Actual Study Start Date  ICMJE March 30, 2020
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2020)
Adverse Events [ Time Frame: Through study completion, an average of 1 year ]
Number of study subjects experiencing adverse events (AEs), dose-limiting toxicities, and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2020)
  • Objective Response Rate (ORR) [ Time Frame: Through study completion, an average of 1 year ]
    ORR is defined as the proportion of subjects with CR or PR
  • Duration of response (DoR) [ Time Frame: Through study completion, an average of 1 year ]
    DoR will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
  • Disease control rate (DCR) [ Time Frame: Through study completion, an average of 1 year ]
    DCR is defined as the proportion of subjects with CR, PR, or SD
  • Progression-free survival (PFS) [ Time Frame: Through study completion, an average of 1 year ]
    PFS is measured from documentation of progression or death from any cause, whichever occurs first
  • Pharmacokinetics (PK) [ Time Frame: Cycles 1-4 (each cycle is 21-28 days) ]
    Serum concentrations of TTX-030 will be tabulated
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 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers
Official Title  ICMJE Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors
Brief Summary

This is a phase 1/1b study of TTX-030 in combination therapy, 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, pharmacodynamics and anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard chemotherapies.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor, Adult
Intervention  ICMJE
  • Combination Product: TTX-030, budigalimab and mFOLFOX6
    Dose and schedule per protocol
  • Combination Product: TTX-030, budigalimab and docetaxel
    Dose and schedule per protocol
  • Combination Product: TTX-030 and mFOLFOX6
    Dose and schedule per protocol
  • Combination Product: TTX-030 and budigalimab
    Dose and schedule per protocol
Study Arms  ICMJE
  • Experimental: Combo 1
    TTX-030 plus budigalimab plus mFOLFOX6
    Intervention: Combination Product: TTX-030, budigalimab and mFOLFOX6
  • Experimental: Combo 2
    TTX-030 plus budigalimab plus docetaxel
    Intervention: Combination Product: TTX-030, budigalimab and docetaxel
  • Experimental: Combo 3
    TTX-030 plus mFOLFOX6
    Intervention: Combination Product: TTX-030 and mFOLFOX6
  • Experimental: Combo 4
    TTX-030 plus budigalimab
    Intervention: Combination Product: TTX-030 and budigalimab
  • Experimental: Combo 5
    TTX-030 plus budigalimab (selected tumors evaluated in expansion)
    Intervention: Combination Product: TTX-030 and budigalimab
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 10, 2020)
152
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Abbreviated Inclusion Criteria:

  1. Age 18 years or older, is willing and able to provide informed consent
  2. Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy in selected tumor types
  3. Life expectancy > 12 weeks
  4. 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 to 110 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tizona Therapeutics Inc 888-585-2990 clinicaltrials@tizonatx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04306900
Other Study ID Numbers  ICMJE TTX-030-002
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 Tizona Therapeutics, Inc
Study Sponsor  ICMJE Tizona Therapeutics, Inc
Collaborators  ICMJE AbbVie
Investigators  ICMJE Not Provided
PRS Account Tizona Therapeutics, Inc
Verification Date June 2020

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