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2020-03-30
2022-11-30
2024-03-27
185
NCT04306900
Trishula Therapeutics, Inc.
Trishula Therapeutics, Inc.
INTERVENTIONAL
TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-03-04 | 2025-06-20 | 2025-07-09 |
2020-03-10 | 2025-07-09 | 2025-07-29 |
2020-03-13 | 2025-07-29 | 2025-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Combo 1 TTX-030 plus budigalimab plus mFOLFOX6 | COMBINATION_PRODUCT: TTX-030, budigalimab and mFOLFOX6
|
| EXPERIMENTAL: Combo 2 TTX-030 plus budigalimab plus docetaxel | COMBINATION_PRODUCT: TTX-030, budigalimab and docetaxel
|
| EXPERIMENTAL: Combo 3 TTX-030 plus mFOLFOX6 | COMBINATION_PRODUCT: TTX-030 and mFOLFOX6
|
| EXPERIMENTAL: Combo 4 TTX-030 plus pembrolizumab | COMBINATION_PRODUCT: TTX-030 and pembrolizumab
|
| EXPERIMENTAL: Combo 5 TTX-030 plus budigalimab (selected tumors evaluated in expansion) | COMBINATION_PRODUCT: TTX-030 and budigalimab
|
| EXPERIMENTAL: Combo 6 TTX-030 plus budigalimab plus nab-paclitaxel + gemcitabine | COMBINATION_PRODUCT: TTX-030, budigalimab, nab-paclitaxel and gemcitabine
|
| EXPERIMENTAL: Combo 7 TTX-030 plus nab-paclitaxel + gemcitabine | COMBINATION_PRODUCT: TTX-030, nab-paclitaxel and gemcitabine
|
| EXPERIMENTAL: Combo 8 Budigalimab plus mFOLFOX6 | COMBINATION_PRODUCT: Budigalimab and mFOLFOX6
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | A DLT was defined as the occurrence of any of the following toxicities within the DLT Evaluation Period if judged by the Investigator and Sponsor to be possibly, probably, or definitely related to TTX-030 or budigalimab. | 7 day load + 1 cycle (1 cycle is 28 days) |
| The Incident of Adverse Events | Number of study subjects experiencing adverse events (AEs) and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations. | Through study completion, an average of 1 year |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Confirmed Objective Response Rate (ORR) | ORR is defined as the proportion of subjects with CR or PR. | Through study completion, an average of 1 year |
| Best Response (BOR) | The BOR was defined as the best response (in the order of CR, PR, stable disease, and PD) by RECIST 1.1 documented from first dose until the end of study, first disease progression, death, or start of new anticancer therapy, whichever was earliest. | Through study completion, an average of 1 year |
| Duration of Response (DOR) | 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. | Through study completion, an average of 1 year |
| Disease Control Rate (DCR) | DCR is defined as the proportion of subjects with CR, PR, or SD per RECIST 1.1 | Through study completion, an average of 1 year |
| Progression-free Survival (PFS) | PFS is measured from documentation of progression or death from any cause, whichever occurs first | Through study completion, an average of 1 year |
| Overall Survival (OS) | OS was defined as the time interval from the first dose of study treatment to death from any cause. Participants who were lost to follow-up or survived until the end of the study were censored at the last date that they were known to be alive. Medians, Q1, and Q3 of OS and the proportion of participants who were alive at 3, 6, 9, and 12 months from Study Day 1 were derived using KM methods. | Through study completion, an average of 1 year |
| Pharmacokinetics (PK) | Serum concentrations of TTX-030 will be tabulated | Cycles 1-4 (each cycle is 21-28 days) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
