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

Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Pembrolizumab or Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors

INTRODUCTION

  • Org Study ID: TTX-030-002
  • Secondary ID: N/A
  • NCT ID: NCT04306900
  • Sponsor: 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.

  • Overall Status
    Active, not recruiting
  • Start Date
    March 30, 2020
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Solid Tumor
  • Adult

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact