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

Trishula Therapeutics

Status and phase: Completed; Phase 1

Conditions: Solid Tumor; Lymphoma

Treatments: Drug: TTX-030; Drug: Pembrolizumab; Drug: nab paclitaxel; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03884556

TTX-030-001

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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56 participants in 3 patient groups

Arm 1, Single Agent

Experimental group

Description:

TTX-030

Treatment:

Drug: TTX-030

Arm 2, Anti-PD-1 Combination

Experimental group

Description:

TTX-030 plus pembrolizumab

Treatment:

Drug: Pembrolizumab

Drug: TTX-030

Arm 4, Chemotherapy Combination

Experimental group

Description:

TTX-030 plus gemcitabine plus nab-paclitaxel

Treatment:

Drug: Gemcitabine

Drug: nab paclitaxel

Drug: TTX-030