Description:
This is a phase 1/1b study of TTX-030 in combination therapy, 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, pharmacodynamics and
anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard
chemotherapies.
Title
- Brief Title: TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers
- Official Title: Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Pembrolizumab or Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
TTX-030-002
- NCT ID:
NCT04306900
Conditions
Purpose
This is a phase 1/1b study of TTX-030 in combination therapy, 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, pharmacodynamics and
anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard
chemotherapies.
Trial Arms
Name | Type | Description | Interventions |
---|
Combo 1 | Experimental | TTX-030 plus budigalimab plus mFOLFOX6 | |
Combo 2 | Experimental | TTX-030 plus budigalimab plus docetaxel | |
Combo 3 | Experimental | TTX-030 plus mFOLFOX6 | |
Combo 4 | Experimental | TTX-030 plus pembrolizumab | |
Combo 5 | Experimental | TTX-030 plus budigalimab (selected tumors evaluated in expansion) | |
Combo 6 | Experimental | TTX-030 plus budigalimab + nab-paclitaxel + gemcitabine | |
Eligibility Criteria
Abbreviated Inclusion Criteria:
1. Age 18 years or older, is willing and able to provide informed consent
2. Histologically confirmed diagnosis of unresectable or metastatic solid tumor
malignancy in selected tumor types
3. Life expectancy > 12 weeks
4. 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: | 110 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Adverse Events |
Time Frame: | Through study completion, an average of 1 year |
Safety Issue: | |
Description: | Number of study subjects experiencing adverse events (AEs), dose-limiting toxicities, and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations. |
Secondary Outcome Measures
Measure: | Objective Response Rate (ORR) |
Time Frame: | Through study completion, an average of 1 year |
Safety Issue: | |
Description: | ORR is defined as the proportion of subjects with CR or PR |
Measure: | Duration of response (DoR) |
Time Frame: | Through study completion, an average of 1 year |
Safety Issue: | |
Description: | DoR will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first. |
Measure: | Disease control rate (DCR) |
Time Frame: | Through study completion, an average of 1 year |
Safety Issue: | |
Description: | DCR is defined as the proportion of subjects with CR, PR, or SD |
Measure: | Progression-free survival (PFS) |
Time Frame: | Through study completion, an average of 1 year |
Safety Issue: | |
Description: | PFS is measured from documentation of progression or death from any cause, whichever occurs first |
Measure: | Pharmacokinetics (PK) |
Time Frame: | Cycles 1-4 (each cycle is 21-28 days) |
Safety Issue: | |
Description: | Serum concentrations of TTX-030 will be tabulated |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Trishula Therapeutics, Inc. |
Trial Keywords
- Gastric (gastroesophageal cancer)
- Advanced Solid Tumor
- Colorectal cancer
- Cancer
- Metastatic Solid Tumor
- Combination Therapy
- CD39
- Adenosine Pathway
- Immunotherapy Immuno-oncology
- PD-1 Checkpoint Inhibitor
- Docetaxel
- Budigalimab
- ABBV-181
- TTX-030
- Non-small cell lung cancer
- Urothelial cell cancer
- Pancreatic cancer
- Pembrolizumab
- Keytruda
- Bladder cancer
- Gemcitabine
- Nab-paclitaxel
Last Updated
June 15, 2021