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

Trishula Therapeutics

Status and phase: Completed; Phase 1

Conditions: Solid Tumor, Adult

Treatments: Combination Product: Budigalimab and mFOLFOX6; Combination Product: TTX-030, nab-paclitaxel and gemcitabine; Combination Product: TTX-030, budigalimab and docetaxel; Combination Product: TTX-030, budigalimab and mFOLFOX6; Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine; Combination Product: TTX-030 and mFOLFOX6; Combination Product: TTX-030 and budigalimab; Combination Product: TTX-030 and pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04306900

TTX-030-002

Details and patient eligibility

About

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.

Enrollment: 185 patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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185 participants in 8 patient groups

Combo 1

Experimental group

Description:

TTX-030 plus budigalimab plus mFOLFOX6

Treatment:

Combination Product: TTX-030, budigalimab and mFOLFOX6

Combo 2

Experimental group

Description:

TTX-030 plus budigalimab plus docetaxel

Treatment:

Combination Product: TTX-030, budigalimab and docetaxel

Combo 3

Experimental group

Description:

TTX-030 plus mFOLFOX6

Treatment:

Combination Product: TTX-030 and mFOLFOX6

Combo 4

Experimental group

Description:

TTX-030 plus pembrolizumab

Treatment:

Combination Product: TTX-030 and pembrolizumab

Combo 5

Experimental group

Description:

TTX-030 plus budigalimab (selected tumors evaluated in expansion)

Treatment:

Combination Product: TTX-030 and budigalimab

Combo 6

Experimental group

Description:

TTX-030 plus budigalimab plus nab-paclitaxel + gemcitabine

Treatment:

Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine

Combo 7

Experimental group

Description:

TTX-030 plus nab-paclitaxel + gemcitabine

Treatment:

Combination Product: TTX-030, nab-paclitaxel and gemcitabine

Combo 8

Experimental group

Description:

Budigalimab plus mFOLFOX6

Treatment:

Combination Product: Budigalimab and mFOLFOX6