Description:
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.
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
TTX-030-001
- NCT ID:
NCT03884556
Conditions
Interventions
Drug | Synonyms | Arms |
---|
TTX-030 | | Arm 1, Single Agent |
Pembrolizumab | | Arm 2, Anti-PD-1 Combination |
Docetaxel | | Arm 3, Chemotherapy Combination |
Gemcitabine | | Arm 4, Chemotherapy Combination |
nab paclitaxel | | Arm 4, Chemotherapy Combination |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm 1, Single Agent | Experimental | TTX-030 | |
Arm 2, Anti-PD-1 Combination | Experimental | TTX-030 plus pembrolizumab | |
Arm 3, Chemotherapy Combination | Experimental | TTX-030 plus docetaxel | |
Arm 4, Chemotherapy Combination | Experimental | TTX-030 plus gemcitabine plus nab-paclitaxel | - TTX-030
- Gemcitabine
- nab paclitaxel
|
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Recommended Phase 2 Dose (RP2D) |
Time Frame: | 1 cycle (each cycle is 21-28 days) |
Safety Issue: | |
Description: | 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
Measure: | Anti-tumor activity |
Time Frame: | Through study completion, an average of 1 year |
Safety Issue: | |
Description: | Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens |
Measure: | Maximum Plasma Concentration (Cmax) |
Time Frame: | Cycles 1-3 (each cycle is 21-28 days) |
Safety Issue: | |
Description: | Pharmacokinetics (PK) of TTX-030 |
Measure: | CD39 Expression |
Time Frame: | Through study completion, an average of 1 year |
Safety Issue: | |
Description: | Pharmacodynamic (PD) biomarkers relating to mechanism of action and immune responses |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Trishula Therapeutics, Inc. |
Trial 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
Last Updated
May 3, 2021