This study will enroll adults with confirmed metastatic pancreatic ductal adenocarcinoma (PDAC, systemic PDAC treatment naïve), Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1, and adequate organ function. Participants will receive pumitamig (also known as BNT327, BMS-986545, or PM8002) in combination with chemotherapy.
Participants will be assigned to treatment arms with modified (m) FOLFIRINOX administration (Treatment Arms 1 and 2) or the treatment arm with nab-paclitaxel + gemcitabine administration (Treatment Arm 3) based on the physician's choice of chemotherapy. Study participants assigned to arms with mFOLFIRINOX administration, will be randomized 1:1 to one of the two arms (Treatment Arms 1 or 2). Once enrollment of Treatment Arms 1 to 3 has been completed, enrollment into the exploratory cohorts (Treatment Arms 4A and 4B) will be opened. There will be a screening period of up to 28 days, followed by a treatment period lasting up to 2 years. After administration of the last dose of study treatment, participants will be followed-up for safety for up to 90 days or until the participant initiates new anticancer treatment (e.g., systemic, radiotherapy/surgery). Thereafter, survival follow-up will be conducted until the participant dies or withdraws consent for survival status follow-up, loss of contact, or study termination (whichever occurs first).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Intravenous (IV) infusion
IV infusion
IV infusion
IV infusion
Flinder's Medical Centre
Bedford Park, Australia
NOT_YET_RECRUITINGPindara Private Hospital
Benowa, Australia
NOT_YET_RECRUITINGPeninsula & South Eastern Haematology and Oncology Group
Frankston, Australia
RECRUITINGThe Alfred Hospital
Melbourne, Australia
NOT_YET_RECRUITINGSt Vincent's Hospital
Melbourne, Australia
NOT_YET_RECRUITINGOne Clinical Research
Mount Pleasant, Australia
NOT_YET_RECRUITINGGenesisCare
Saint Leonards, Australia
RECRUITINGSunshine Coast Private Hospital
Sunshine Coast, Australia
NOT_YET_RECRUITINGWestmead Hospital
Sydney, Australia
NOT_YET_RECRUITINGTsinghua Changgung Hospital
Beijing, China
RECRUITING...and 14 more locations
Confirmed overall response rate
For each treatment arm. Defined as the percentage of study participants in whom a confirmed complete response (CR) or confirmed partial response (PR) (assessed by the investigator per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]) is observed as best overall response.
Time frame: Up to 24 months
Occurrence of treatment emergent adverse events (TEAEs) by severity
According to (US National Cancer Institute) Common Terminology Criteria for Adverse Events version 5.0 \[CTCAE v5.0\]). By relationship and for each treatment arm.
Time frame: From the first dose of study treatment until 90 days after the last dose of study treatment (up to 32 months).
Occurrence of dose interruptions, reductions, and discontinuations due to TEAEs
For each treatment arm.
Time frame: Up to 24 months after first dose
Disease control rate
Defined as the percentage of study participants in whom a confirmed CR or confirmed PR or stable disease (SD), (per RECIST v1.1, SD assessed at least 6 weeks after randomization/assignment to treatment) is observed as best overall response.
Time frame: Up to 24 months
Duration of response
Defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (disease progression as assessed by the investigator per RECIST v1.1), or death from any cause, whichever occurs first.
Time frame: Up to 30 months
Progression free survival
Defined as the time from first dose of study treatment to first documented tumor progression (disease progression assessed by investigator per RECIST v1.1), or death from any cause, whichever occurs first.
Time frame: Up to 32 months
Overall survival
Defined as the time from first dose of study treatment to death from any cause.
Time frame: Up to 32 months
Pharmacokinetic (PK) assessment: Maximum concentration (Cmax) derived from serum concentration of pumitamig
At Cycle 1 and Cycle 6 as data permits.
Time frame: Up to 6 months from first dose of study treatment
PK assessment: Minimum concentration (Cmin) derived from serum concentration of pumitamig
At Cycle 1 and Cycle 6 as data permits.
Time frame: Up to 6 months from first dose of study treatment
Incidence of detectable pumitamig anti-drug antibodies in serum
From before the first dose of study treatment until the last survival follow-up visit.
Time frame: Up to 32 months
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