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Completed

NCT Number: NCT04306900

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

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.

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Key information

Conditions

Solid Tumor, Adult Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Center, Seogu, Busan, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Abbreviated Inclusion Criteria:

  • Age 18 years or older, is willing and able to provide informed consent
  • Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy in selected tumor types
  • Life expectancy > 12 weeks
  • 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.
  • 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

Treatment and study plan

TTX-030, budigalimab and mFOLFOX6

Combination Product

Dose and schedule per protocol

TTX-030, budigalimab and docetaxel

Combination Product

Dose and schedule per protocol

TTX-030 and mFOLFOX6

Combination Product

Dose and schedule per protocol

TTX-030 and budigalimab

Combination Product

Dose and schedule per protocol

TTX-030, budigalimab, nab-paclitaxel and gemcitabine

Combination Product

Dose and schedule per protocol

TTX-030 and pembrolizumab

Combination Product

Dose and schedule per protocol

TTX-030, nab-paclitaxel and gemcitabine

Combination Product

Dose and schedule per protocol

Budigalimab and mFOLFOX6

Combination Product

Dose and schedule per protocol

Primary outcomes

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

    Time frame: 7 day load + 1 cycle (1 cycle is 28 days)

    A DLT was defined as the occurrence of any of the following toxicities within the DLT Evaluation Period if judged by the Investigator and Sponsor to be possibly, probably, or definitely related to TTX-030 or budigalimab.

  2. The Incident of Adverse Events

    Time frame: Through study completion, an average of 1 year

    Number of study subjects experiencing adverse events (AEs) and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.

Secondary outcomes

  1. Confirmed Objective Response Rate (ORR)

    Time frame: Through study completion, an average of 1 year

    ORR is defined as the proportion of subjects with CR or PR.

  2. Best Response (BOR)

    Time frame: Through study completion, an average of 1 year

    The BOR was defined as the best response (in the order of CR, PR, stable disease, and PD) by RECIST 1.1 documented from first dose until the end of study, first disease progression, death, or start of new anticancer therapy, whichever was earliest.

  3. Duration of Response (DOR)

    Time frame: Through study completion, an average of 1 year

    DoR will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.

  4. Disease Control Rate (DCR)

    Time frame: Through study completion, an average of 1 year

    DCR is defined as the proportion of subjects with CR, PR, or SD per RECIST 1.1

  5. Progression-free Survival (PFS)

    Time frame: Through study completion, an average of 1 year

    PFS is measured from documentation of progression or death from any cause, whichever occurs first

  6. Overall Survival (OS)

    Time frame: Through study completion, an average of 1 year

    OS was defined as the time interval from the first dose of study treatment to death from any cause. Participants who were lost to follow-up or survived until the end of the study were censored at the last date that they were known to be alive. Medians, Q1, and Q3 of OS and the proportion of participants who were alive at 3, 6, 9, and 12 months from Study Day 1 were derived using KM methods.

  7. Pharmacokinetics (PK)

    Time frame: Cycles 1-4 (each cycle is 21-28 days)

    Serum concentrations of TTX-030 will be tabulated

Sponsors and collaborators

Lead sponsor

Trishula Therapeutics, Inc.

Industry

Collaborators

  • AbbVie

Registry information

Official study title

Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Pembrolizumab or Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
Mar 13, 2020
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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