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

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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

INTRODUCTION

  • Org Study ID: TTX-030-001
  • Secondary ID: N/A
  • NCT ID: NCT03884556
  • Sponsor: Trishula Therapeutics, Inc.

BRIEF SUMMARY

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.

  • Overall Status
    Completed
  • Start Date
    April 10, 2019
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Recommended Phase 2 Dose (RP2D)

Primary Outcome 1 - Timeframe: 1 cycle (each cycle is 21-28 days)

CONDITION

  • Solid Tumor
  • Lymphoma

ELIGIBILITY

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

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

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