Pancreatic cancer anatomy concept , malignant tumor of pancreas: © Лилия Захарчук - stock.adobe.com
About the Phase 2 Study of TX-030
Trial Name: An Open-Label Multicenter 3-Arm Randomized Phase 2 Study to Assess the Efficacy and Safety of TTX-030 and Chemotherapy With or Without Budigalimab, Compared to Chemotherapy Alone, for the Treatment of Patients Not Previously Treated for Metastatic Pancreatic Adenocarcinoma
ClinicalTrials.gov Identifier: NCT06119217
Sponsor: Trishula Therapeutics, Inc.
Completion Date: June 2027
A phase 2 trial (NCT06119217) evaluating the safety and efficacy of TTX-030 as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (PDAC) has been initiated, according to Trishula Therapeutics, Inc.1
TX-030 is a potential first-in-class, anti-CD39 antibody which works to inhibit the activity of CD39, the first step in the generation of adenosine in the tumor microenvironment. The agent halts immune-suppressive extracellular adenosine from forming and can maintain high levels of immune-activating extracellular adenosine triphosphate. This then stimulates dendritic and myeloid-derived cells, leading to the promotion of innate and adaptive antitumor immunity.
The trial plans to assess TTX-030 combined with chemotherapy, with or without budigalimab, an investigational anti-PD-1 antibody, compared with chemotherapy alone for patients with PDAC.
"There is significant unmet need for new treatment options for pancreatic cancer," said Anil Singhal, chief executive officer of Trishula Therapeutics, in a press release.1 "We look forward to building on the promising phase 1 results to potentially advance the treatment landscape with TTX-030, which may bring benefit to patients with advanced pancreatic cancer."
The phase 2 study plans to enroll approximately 180 patients who will be randomly assigned into 1 of 3 treatment arms.2 In the first arm, patients will receive TTX-030 and chemotherapy, consisting of gemcitabine and nab-paclitaxel. In the second arm, TTX-030 and chemotherapy plus budigalimab will be administered. In the third arm, patients will be treated with chemotherapy alone.
Enrollment is open to patients aged 18 years or older who have a histologically or cytologically confirmed diagnosis of metastatic PDAC. Patients must not have received prior systemic treatment for metastatic disease, have any evidence of measurable disease per RECIST 1.1, and have an ECOG performance status of 0 or 1. Additionally, patients must be appropriate for treatment with nab-paclitaxel and gemcitabine.
If patients have a history of clinically significant allergy or hypersensitivity to planned study treatment components or to any monoclonal antibody or have used an investigational agent within 14 days prior to the first dose of the study drug, they will be excluded from the study. Patients with a history of autoimmune disease, those who have received live vaccine within 28 days prior to the first dose of study drug, and those with uncontrolled intercurrent illness will also be excluded from the trial.
The primary end point being investigated in the trial is progression-free survival (PFS) in a biomarker-enriched population, and secondary end points consist of PFS in the overall population, safety, objective response rate, duration of response, and overall survival.
The estimated study completion date is June 2027.
Trishula Therapeutics initiates phase 2 trial of TTX-030, an anti-CD39 antibody, in first line metastatic pancreatic cancer patients. News release. Trishula Therapeutics, Inc. November 9, 2023. Accessed November 9, 2023. https://tinyurl.com/yckt5s8b
Phase 2 study of TTX-030 and chemotherapy with or without budigalimab for 1L mPDAC patients. ClinicalTrials.gov. Updated November 7, 2023. Accessed November 9, 2023. https://clinicaltrials.gov/study/NCT06119217