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

NCT03884556 | Completed Phase 1 Results FDA Drug

• 1 other identifier: TTX-030-001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Solid Tumor; Lymphoma

Keywords

Cancer; Metastatic Solid Tumors; Advanced Solid Tumors; Relapsed/Refractory Lymphoma; Prostrate Cancer; Pancreatic Cancer; Monotherapy; Combination Therapy; CD39; Adenosine Pathway; Immunotherapy; Immuno-oncology; PD-1; Checkpoint Inhibitor; Nab-paclitaxel; Gemcitabine; Pembrolizumab; Docetaxel; Bladder Cancer; Lung Cancer

Outcome Measures

Primary Outcomes (2)

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

  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.

  1 cycle (each cycle is 21-28 days)

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

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

  Through study completion, an average of 1 year

Secondary Outcomes (2)

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

  Through study completion, an average of 1 year

• Maximum Plasma Concentration (Cmax)

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

Study Arms (3)

Arm 1, Single Agent

EXPERIMENTAL

TTX-030

Drug: TTX-030

Arm 2, Anti-PD-1 Combination

EXPERIMENTAL

TTX-030 plus pembrolizumab

Drug: TTX-030; Drug: Pembrolizumab

Arm 4, Chemotherapy Combination

EXPERIMENTAL

TTX-030 plus gemcitabine plus nab-paclitaxel

Drug: TTX-030; Drug: Gemcitabine; Drug: nab paclitaxel

Interventions

TTX-030 DRUG

Variable dose and schedule

Arm 1, Single Agent; Arm 2, Anti-PD-1 Combination; Arm 4, Chemotherapy Combination

Pembrolizumab DRUG

Dose and schedule per standard of care

Arm 2, Anti-PD-1 Combination

Gemcitabine DRUG

Dose and schedule per standard of care

Arm 4, Chemotherapy Combination

nab paclitaxel DRUG

Dose and schedule per standard of care

Arm 4, Chemotherapy Combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trishula Therapeutics, Inc.: lead

Study Sites (16)

UC Irvine Cancer Center

Orange, California, 92868, United States

Location

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Nebraska Cancer Center Oncology Hematology West P.C.

Omaha, Nebraska, 68130, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44122, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

West Cancer Center and Research Institute

Germantown, Tennessee, 38138, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

Huntsman Cancer Intitute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Lymphoma; Neoplasms; Pancreatic Neoplasms; Urinary Bladder Neoplasms; Lung Neoplasms

Interventions

pembrolizumab; Gemcitabine; Taxes

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Economics; Health Care Economics and Organizations

Results Point of Contact

• Title: Trishula Info
• Organization: Trishula Therapeutics

info@trishulatx.com

(650) 509-5732

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2019
• First Posted: March 21, 2019
• Study Start: April 10, 2019
• Primary Completion: November 30, 2022
• Study Completion: September 29, 2023
• Last Updated: July 2, 2025
• Results First Posted: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)