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

Part of paid clinical trials in Orange, California.

Sponsor
Trishula Therapeutics, Inc.
Study ID
NCT03884556
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TTX-030 — DRUG
    Variable dose and schedule
  • Pembrolizumab — DRUG
    Dose and schedule per standard of care
  • Gemcitabine — DRUG
    Dose and schedule per standard of care
  • nab paclitaxel — DRUG
    Dose and schedule per standard of care

Study Details

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.

Key Dates

Start date
Apr 10, 2019
Status verified
Jun 2025
Primary completion
Nov 30, 2022
Completion
Sep 29, 2023

Study Design

Enrollment
56 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1, Single Agent
    TTX-030
  • Experimental: Arm 2, Anti-PD-1 Combination
    TTX-030 plus pembrolizumab
  • Experimental: Arm 4, Chemotherapy Combination
    TTX-030 plus gemcitabine plus nab-paclitaxel

Primary Outcome Measure

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) [ Time Frame: 1 cycle (each cycle is 21-28 days) ]

Locations (16)

FacilityCityStateZIPSite coordinators
UC Irvine Cancer CenterOrangeCalifornia92868-
UC Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
University of California, San FranciscoSan FranciscoCalifornia94143-
Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Norton Cancer InstituteLouisvilleKentucky40202-
Nebraska Cancer Center Oncology Hematology West P.C.OmahaNebraska68130-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Columbia University Irving Medical CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Montefiore Medical CenterThe BronxNew York10461-
University Hospitals Cleveland Medical CenterClevelandOhio44122-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
West Cancer Center and Research InstituteGermantownTennessee38138-
Sarah Cannon Research InstituteNashvilleTennessee37203-
NEXT OncologySan AntonioTexas78229-
Huntsman Cancer IntituteSalt Lake CityUtah84112-

Related coverage on Hipa.ai

Find similar trials in Orange, CA

By research site
UC Irvine Cancer Center· Orange, CAUC Davis Comprehensive Cancer Center· Sacramento, CAUniversity of California, San Francisco· San Francisco, CASylvester Comprehensive Cancer Center· Miami, FLNorton Cancer Institute· Louisville, KYNebraska Cancer Center Oncology Hematology West P.C.· Omaha, NE

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