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

Phase 1

Completed

• Conditions: Lymphoma; Solid Tumor
• Interventions: Drug: TTX-030; Drug: Pembrolizumab; Drug: Gemcitabine; Drug: nab paclitaxel

• Registration Number: NCT03884556
• Lead Sponsor: Trishula Therapeutics, Inc.

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-03-16
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-21
• Study Start: 2019-04-10
• Primary Completion: 2022-11-30
• Study Completion: 2023-09-29
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm 1, Single Agent	TTX-030	TTX-030
Arm 2, Anti-PD-1 Combination	TTX-030	TTX-030 plus pembrolizumab
Arm 4, Chemotherapy Combination	TTX-030	TTX-030 plus gemcitabine plus nab-paclitaxel
Arm 4, Chemotherapy Combination	nab paclitaxel	TTX-030 plus gemcitabine plus nab-paclitaxel
Arm 2, Anti-PD-1 Combination	Pembrolizumab	TTX-030 plus pembrolizumab
Arm 4, Chemotherapy Combination	Gemcitabine	TTX-030 plus gemcitabine plus nab-paclitaxel

Primary Outcome Measures

Name	Time	Method
Recommended Phase 2 Dose (RP2D)	1 cycle (each cycle is 21-28 days)	Assess the safety profile, dose limiting toxicity (DLT), maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of TTX-030 when administered intravenously (IV) as a single agent and in combination with agents in specified regimens to subjects with advanced solid tumor malignancies or lymphoma

Secondary Outcome Measures

Name	Time	Method
Anti-tumor activity	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
CD39 Expression	Through study completion, an average of 1 year	Pharmacodynamic (PD) biomarkers relating to mechanism of action and immune responses
Maximum Plasma Concentration (Cmax)	Cycles 1-3 (each cycle is 21-28 days)	Pharmacokinetics (PK) of TTX-030

Trial Locations

Locations (16)

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

West Cancer Center and Research Institute; 🇺🇸 Germantown, Tennessee, United States

NEXT Oncology; 🇺🇸 San Antonio, Texas, United States

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Nebraska Cancer Center Oncology Hematology West P.C.; 🇺🇸 Omaha, Nebraska, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

UPMC Hillman Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

UC Irvine Cancer Center; 🇺🇸 Orange, California, United States

UC Davis Comprehensive Cancer Center; 🇺🇸 Sacramento, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

Norton Cancer Institute; 🇺🇸 Louisville, Kentucky, United States

Huntsman Cancer Intitute; 🇺🇸 Salt Lake City, Utah, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States