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

Lymphoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03884556
• Other study ID #: TTX-030-001
• Status: Completed
• Phase: Phase 1
• Start date: April 10, 2019
• Est. completion date: September 29, 2023

Study information

• Verified date: October 2023
• Source: Trishula Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 29, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Abreviated Inclusion Criteria

1. 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.

2. Age 18 years or older, is willing and able to provide informed consent

3. Evidence of measurable disease

4. Life expectancy > 12 weeks and Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Abbreviated Exclusion Criteria

1. History of allergy or hypersensitivity to study treatment components. Patients with a history of severe hypersensitivity reaction to any monoclonal antibody.

2. Use of investigational agent within 28 days prior to the first dose of study treatment and throughout the study

3. Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy

4. History of severe autoimmune disease

5. Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment

Related Conditions & MeSH terms

• Lymphoma
• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	West Cancer Center and Research Institute	Germantown	Tennessee
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Columbia University Irving Medical Center	New York	New York
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	UC Irvine Cancer Center	Orange	California
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	UC Davis Comprehensive Cancer Center	Sacramento	California
United States	Huntsman Cancer Intitute	Salt Lake City	Utah
United States	NEXT Oncology	San Antonio	Texas
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Trishula Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recommended Phase 2 Dose (RP2D)	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	1 cycle (each cycle is 21-28 days)
Secondary	Anti-tumor activity	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	Maximum Plasma Concentration (Cmax)	Pharmacokinetics (PK) of TTX-030	Cycles 1-3 (each cycle is 21-28 days)
Secondary	CD39 Expression	Pharmacodynamic (PD) biomarkers relating to mechanism of action and immune responses	Through study completion, an average of 1 year