Randomized Phase 3 Trial of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

JRCT ID: jRCT2061240084

Registered date:14/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Metastatic pancreatic ductal adenocarcinoma (mPDAC)
• Date of first enrollment: 20/01/2025
• Target sample size: 50
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

Arm A (Experimental Arm)
Quemliclustat, Nab-paclitaxel, and Gemcitabine will be administered by injection.

Arm B (Comparator Arm)
Placebo, Nab-paclitaxel, and Gemcitabine will be administered by injection.

Outcome(s)

• Primary Outcome: Overall survival (OS)

Secondary Outcome

Progression-free Survival (PFS)
Objective response rate (ORR)
Duration of response (DoR)
Disease Control Rate (DCR)
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Have histologically or cytologically confirmed PDAC that is metastatic.
2. Have not been previously treated for PDAC in the metastatic setting.
a. Prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed at least 12 months before randomization.
b. Prior palliative radiotherapy is allowed if completed at least 2 weeks prior to randomization and adverse events (AEs) have resolved to Grade 1 or less before randomization. Prior and/or placement of a biliary stent/tube is permitted if any treatment-related AEs have improved to Grade <= 1 and the patient is not exhibiting any signs/symptoms of biliary obstruction.
3. Eastern Cooperative Oncology Group PS of 0 to 1 within 7 days of randomization.
4. At least 1 target lesion measurable by computed tomography (CT)/magnetic resonance imaging (MRI) per RECIST v1.1. not within a field of prior radiation therapy.

Exclude criteria

1.Previously treated for locally advanced, unresectable PDAC.
2.History of brain metastases or leptomeningeal metastases.
3.Prior treatment with a CD73 antagonist or inhibitor.
4.Underlying medical or psychiatric conditions that, in the investigator or sponsor's opinion, will make the administration of study-specified therapy hazardous.

Related Information

• Primary Sponsor: Nasermoaddeli Ali
• Secondary Sponsor: Arcus Biosciences, Inc.
• Secondary ID(s): NCT06608927