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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 : September 21, 2020
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Trishula Therapeutics, Inc.

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.


Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Combination Product: TTX-030, budigalimab and mFOLFOX6 Combination Product: TTX-030, budigalimab and docetaxel Combination Product: TTX-030 and mFOLFOX6 Combination Product: TTX-030 and budigalimab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 30, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: Combo 1
TTX-030 plus budigalimab plus mFOLFOX6
Combination Product: TTX-030, budigalimab and mFOLFOX6
Dose and schedule per protocol

Experimental: Combo 2
TTX-030 plus budigalimab plus docetaxel
Combination Product: TTX-030, budigalimab and docetaxel
Dose and schedule per protocol

Experimental: Combo 3
TTX-030 plus mFOLFOX6
Combination Product: TTX-030 and mFOLFOX6
Dose and schedule per protocol

Experimental: Combo 4
TTX-030 plus budigalimab
Combination Product: TTX-030 and budigalimab
Dose and schedule per protocol

Experimental: Combo 5
TTX-030 plus budigalimab (selected tumors evaluated in expansion)
Combination Product: TTX-030 and budigalimab
Dose and schedule per protocol




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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

  5. Pharmacokinetics (PK) [ Time Frame: Cycles 1-4 (each cycle is 21-28 days) ]
    Serum concentrations of TTX-030 will be tabulated



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04306900


Contacts
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Contact: Trishula Therapeutics, Inc. +1 888-480-0554 clinicaltrials@trishulatx.com

Locations
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United States, Florida
Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Reisy Guedes, BS, CRC    305-243-8807    rxg957@med.miami.edu   
Ocala Oncology Center PL Recruiting
Ocala, Florida, United States, 34474
Contact: Sanjit Nirmalanandhan    352-547-1958    sanjit.nirmalanandhan@usoncology.com   
Orlando Health UF Health Cancer Center Recruiting
Orlando, Florida, United States, 32835
Contact: Karin Donaldson    321-841-9821    karin.donaldson@orlandohealth.com   
United States, Georgia
IACT Health - John B. Amos Cancer Center Recruiting
Columbus, Georgia, United States, 31904
Contact: Katrina Quidley, MHA, ACRP-CP    706-229-7439    kquidley@iacthealth.com   
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    mmeays@nebraskacancer.com   
United States, Ohio
University of Toledo Recruiting
Toledo, Ohio, United States, 43614
Contact: Jill Sholl    419-383-4553    jill.sholl@utoledo.edu   
Contact: Jessica Obarski    419-383-6972    jessica.obarski@utoledo.edu   
United States, South Carolina
Prisma-Health Cancer Institute Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jane W McClain    864-455-3781    jmcclain@ghs.org   
United States, Tennessee
West Cancer Center and Research Institute Recruiting
Germantown, Tennessee, United States, 38138
Contact: Amanda Fletcher    901-683-0055    afletcher@westclinic.com   
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Referral Line    615-329-7478    Cann.researchreferrals@scresearch.net   
United States, Texas
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: Sarah Gomez    210-580-9521    sgomez@nextsat.com   
Sponsors and Collaborators
Trishula Therapeutics, Inc.
AbbVie
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Responsible Party: Trishula Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04306900    
Other Study ID Numbers: TTX-030-002
First Posted: March 13, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
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.:
Gastric (gastroesophageal cancer)
Advanced Solid Tumor
Prostate cancer
Colorectal cancer
Head and neck squamous cell carcinoma
Renal cell carcinoma
Cancer
Metastatic Solid Tumor
Combination Therapy
CD39
Adenosine Pathway
Immunotherapy Immuno-oncology
PD-1 Checkpoint Inhibitor
Docetaxel
Budigalimab
ABBV-181
TTX-030
NSCLC
Non-small cell lung cancer
Breast cancer
Additional relevant MeSH terms:
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Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action