Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 110 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10461
Contact:
Mohammad Ghalib
718-405-8515
mhghalib@montefiore.org

More Details

Status
Recruiting
Sponsor
Trishula Therapeutics, Inc.

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.