Clinical Trials /

TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers

NCT04306900

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers
  • 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

Clinical Trial IDs

  • ORG STUDY ID: TTX-030-002
  • NCT ID: NCT04306900

Conditions

  • Solid Tumor, Adult

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.

Trial Arms

NameTypeDescriptionInterventions
Combo 1ExperimentalTTX-030 plus budigalimab plus mFOLFOX6
    Combo 2ExperimentalTTX-030 plus budigalimab plus docetaxel
      Combo 3ExperimentalTTX-030 plus mFOLFOX6
        Combo 4ExperimentalTTX-030 plus budigalimab
          Combo 5ExperimentalTTX-030 plus budigalimab (selected tumors evaluated in expansion)

            Eligibility 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
                  
            Maximum Eligible Age:110 Years
            Minimum Eligible Age:18 Years
            Eligible Gender:All
            Healthy Volunteers:No

            Primary Outcome Measures

            Measure:Adverse Events
            Time Frame:Through study completion, an average of 1 year
            Safety Issue:
            Description: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

            Measure:Objective Response Rate (ORR)
            Time Frame:Through study completion, an average of 1 year
            Safety Issue:
            Description:ORR is defined as the proportion of subjects with CR or PR
            Measure:Duration of response (DoR)
            Time Frame:Through study completion, an average of 1 year
            Safety Issue:
            Description: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.
            Measure:Disease control rate (DCR)
            Time Frame:Through study completion, an average of 1 year
            Safety Issue:
            Description:DCR is defined as the proportion of subjects with CR, PR, or SD
            Measure:Progression-free survival (PFS)
            Time Frame:Through study completion, an average of 1 year
            Safety Issue:
            Description:PFS is measured from documentation of progression or death from any cause, whichever occurs first
            Measure:Pharmacokinetics (PK)
            Time Frame:Cycles 1-4 (each cycle is 21-28 days)
            Safety Issue:
            Description:Serum concentrations of TTX-030 will be tabulated

            Details

            Phase:Phase 1
            Primary Purpose:Interventional
            Overall Status:Recruiting
            Lead Sponsor:Tizona Therapeutics, Inc

            Trial Keywords

            • 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
            • Tizona

            Last Updated

            March 30, 2020