Einstein Montefiore

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

Purpose

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.

Condition

Solid Tumor, Adult

Eligibility

Eligible Ages: Between 18 Years and 110 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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

Study Design

Phase: Phase 1
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Combo 1	TTX-030 plus budigalimab plus mFOLFOX6	Combination Product: TTX-030, budigalimab and mFOLFOX6 Dose and schedule per protocol
Experimental Combo 2	TTX-030 plus budigalimab plus docetaxel	Combination Product: TTX-030, budigalimab and docetaxel Dose and schedule per protocol
Experimental Combo 3	TTX-030 plus mFOLFOX6	Combination Product: TTX-030 and mFOLFOX6 Dose and schedule per protocol
Experimental Combo 4	TTX-030 plus pembrolizumab	Combination Product: TTX-030 and pembrolizumab Dose and schedule per protocol
Experimental Combo 5	TTX-030 plus budigalimab (selected tumors evaluated in expansion)	Combination Product: TTX-030 and budigalimab Dose and schedule per protocol
Experimental Combo 6	TTX-030 plus budigalimab plus nab-paclitaxel + gemcitabine	Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine Dose and schedule per protocol
Experimental Combo 7	TTX-030 plus nab-paclitaxel + gemcitabine	Combination Product: TTX-030, nab-paclitaxel and gemcitabine Dose and schedule per protocol
Experimental Combo 8	Budigalimab plus mFOLFOX6	Combination Product: Budigalimab and mFOLFOX6 Dose and schedule per protocol

More Details

Status: Completed
Sponsor: Trishula Therapeutics, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.