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NCT Number: NCT03884556

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

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.

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Key information

Conditions

Solid Tumor Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UC Irvine Cancer Center, Orange, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Abreviated Inclusion Criteria

  • 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.
  • Age 18 years or older, is willing and able to provide informed consent
  • Evidence of measurable disease
  • Life expectancy > 12 weeks and Eastern Cooperative Oncology Group (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

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

Primary outcomes

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

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

    A DLT was defined as any clinically significant AE that occurred during Treatment Cycle 1 that the Investigator or Sponsor considered as possibly or likely related to TTX-030 as a single agent, or the combination of TTX-030 and other agent(s), and met the following criteria: NCI CTCAE Version 5.0 Grade 5 event, Grade 4 hematological or Grade≥3 non-hematological toxicities, or Grade≥3 irAEs. Laboratory abnormalities that were asymptomatic and deemed not clinically significant were not regarded as DLTs.

    During Dose Escalation, each dosing cohort was completed through the DLT observation window before escalation was allowed within its arm. In each Safety Lead-in cohort, all participants were closely monitored for the occurrence of DLTs.

  2. Objective Response Rate (ORR) - Arm 1 and Arm 2 Expansion Cohorts

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

    Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens

Secondary outcomes

  1. Objective Response Rate (ORR) (Except for Arm 1 and 2 Expansion Cohorts, Where ORR Was a Primary Endpoint)

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

    Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens

  2. Maximum Plasma Concentration (Cmax)

    Time frame: Cycles 1-3 (each cycle is 21-28 days)

    PK parameters of serum TTX-030 by Arm and Dose - Cycle 1

Sponsors and collaborators

Lead sponsor

Trishula Therapeutics, Inc.

Industry

Registry information

Official study title

Phase 1/1b Study of the Safety of TTX-030 as a Single Agent and in Combination With Pembrolizumab or Chemotherapy in Patients With Lymphoma or Solid Tumor Malignancies

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Mar 21, 2019
Registry last updated
Jul 2, 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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