Clinical trial NCT03884556: TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: Trishula Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-21
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recommended Phase 2 Dose (RP2D)
timeFrame: 1 cycle (each cycle is 21-28 days)
Secondary outcomes:
measure: Anti-tumor activity
timeFrame: Through study completion, an average of 1 year
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Cycles 1-3 (each cycle is 21-28 days)
measure: CD39 Expression
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Orange
country: United States
facility: UC Irvine Cancer Center
state: California
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Omaha
country: United States
facility: Nebraska Cancer Center Oncology Hematology West P.C.
state: Nebraska
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Germantown
country: United States
facility: West Cancer Center and Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: San Antonio
country: United States
facility: NEXT Oncology
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Intitute
state: Utah
Study officials:
References: