Clinical Trials /

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

NCT03884556

Description:

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.

Related Conditions:
  • Lymphoma
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: TTX-030-001
  • NCT ID: NCT03884556

Conditions

  • Solid Tumor
  • Lymphoma

Interventions

DrugSynonymsArms
TTX-030Arm 1, Single Agent
PembrolizumabArm 2, Anti-PD-1 Combination
DocetaxelArm 3, Chemotherapy Combination
GemcitabineArm 4, Chemotherapy Combination
nab paclitaxelArm 4, Chemotherapy Combination

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Arm 1, Single AgentExperimentalTTX-030
  • TTX-030
Arm 2, Anti-PD-1 CombinationExperimentalTTX-030 plus pembrolizumab
  • TTX-030
  • Pembrolizumab
Arm 3, Chemotherapy CombinationExperimentalTTX-030 plus docetaxel
  • TTX-030
  • Docetaxel
Arm 4, Chemotherapy CombinationExperimentalTTX-030 plus gemcitabine plus nab-paclitaxel
  • TTX-030
  • Gemcitabine
  • nab paclitaxel

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Recommended Phase 2 Dose (RP2D)
Time Frame:1 cycle (each cycle is 21-28 days)
Safety Issue:
Description: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

Secondary Outcome Measures

Measure:Anti-tumor activity
Time Frame:Through study completion, an average of 1 year
Safety Issue:
Description:Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens
Measure:Maximum Plasma Concentration (Cmax)
Time Frame:Cycles 1-3 (each cycle is 21-28 days)
Safety Issue:
Description:Pharmacokinetics (PK) of TTX-030
Measure:CD39 Expression
Time Frame:Through study completion, an average of 1 year
Safety Issue:
Description:Pharmacodynamic (PD) biomarkers relating to mechanism of action and immune responses

Details

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

Trial Keywords

  • Cancer
  • Metastatic Solid Tumors
  • Advanced Solid Tumors
  • Relapsed/Refractory Lymphoma
  • Prostrate Cancer
  • Pancreatic Cancer
  • Monotherapy
  • Combination Therapy
  • CD39
  • Adenosine Pathway
  • Immunotherapy
  • Immuno-oncology
  • PD-1
  • Checkpoint Inhibitor
  • Nab-paclitaxel
  • Gemcitabine
  • Pembrolizumab
  • Docetaxel
  • Bladder Cancer
  • Lung Cancer

Last Updated

May 3, 2021