CompletedPhase 1

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

United States56 participantsStarted 2019-04-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Advanced solid tumor malignancy or relapsed/refractory lymphoma, or
✓. Age 18 years or older, is willing and able to provide informed consent
✓. Evidence of measurable disease
✓. Life expectancy \> 12 weeks and Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Exclusion criteria

✕. History of allergy or hypersensitivity to study treatment components. Patients with a history of severe hypersensitivity reaction to any monoclonal antibody.
✕. Use of investigational agent within 28 days prior to the first dose of study treatment and throughout the study
✕. Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
✕. History of severe autoimmune disease
✕. Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment

What they're measuring

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

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

Objective Response Rate (ORR) - Arm 1 and Arm 2 Expansion Cohorts

Timeframe: Through study completion, an average of 1 year

Trial details

NCT IDNCT03884556

SponsorTrishula Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-30

Results submitted2024-11-04

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