Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients

Study Overview
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Brief Summary
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This is a Phase 2, multicenter, open-label, 3-arm, randomized, parallel group study to evaluate the efficacy and safety of TTX-030 with or without budigalimab in combination with chemotherapy (gemcitabine + nab-paclitaxel) in subjects with metastatic PDAC who did not have prior treatment for metastatic disease and are eligible to receive gemcitabine and nab-paclitaxel chemotherapy as SOC.

Official Title
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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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Combination Product: TTX-030, nab-paclitaxel and gemcitabine
* Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine
* Combination Product: Nab-Paclitaxel and gemcitabine


Participation Criteria
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Eligibility Criteria
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Abbreviated Inclusion Criteria: Age 18 years or older, is willing and able to provide informed consent Histologically or cytologically confirmed diagnosis of metastatic PDAC. No prior systemic treatment for metastatic disease. Evidence of measurable disease per RECIST 1.1. Appropriate for treatment with nab-paclitaxel and gemcitabine chemotherapy. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. Abbreviated Exclusion Criteria: History of clinically significant allergy or hypersensitivity to planned study treatment components or to any monoclonal antibody Use of investigational agent within 14 days prior to the first dose of study drug History of autoimmune disease Subject has received live vaccine within 28 days prior to the first dose of study drug Has uncontrolled intercurrent illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Parallel Group Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>TTX-030 plus nab-paclitaxel and gemcitabine | Combination Product: TTX-030, nab-paclitaxel and gemcitabine<br>* Dose and schedule per protocol<br>|
| Experimental: Arm 2<br>TTX-030 plus budigalimab plus nab-paclitaxel and gemcitabine | Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine<br>* Dose and schedule per protocol<br>|
| Active Comparator: Arm 3<br>Nab-Paclitaxel and gemcitabine | Combination Product: Nab-Paclitaxel and gemcitabine<br>* Dose and schedule per protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) - Biomarker Enriched Population | PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) - Overall Population | PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first | Through study completion, an average of 1 year | 
| Objective Response Rate (ORR) | ORR is defined as the percentage of subjects who achieve best overall response (BOR) of either complete response (CR) or partial response (PR) | Through study completion, an average of 1 year | 
| Duration of Response (DoR) | DoR will be defined as the time from the first documentation of disease response (CR or PR) until first documentation of progression or death from any cause, whichever comes first. | Through study completion, an average of 1 year | 
| Overall Survival (OS) | OS is defined as the time from randomization until death due to any cause. | Through study completion, an average of 1 year | 
| Adverse Events | Type, severity, and frequency of treatment-emergent AEs | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Pancreatic Adenocarcinoma, Combination Therapy, CD39, Adenosine Pathway, Immunotherapy, Immuno-oncology, Pancreatic Ductal Adenocarcinoma, PD-1 Checkpoint Inhibitor, Budigalimab, TTX-030, metastatic