A Phase III study to assess the efficacy and safety of STNM01 as a second-line therapy in patients with unresectable pancreatic cancer who failed to respond to first-line chemotherapy

JRCT ID: jRCT2031240526

Registered date:06/12/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Patients with unresectable advanced pancreatic cancer who have not adequately responded to first-lin
• Date of first enrollment: 06/12/2024
• Target sample size: 250
• Study type: Interventional

Intervention(s)

In the STNM01 + nal-IRI/FL group, the study drug treatment period is from Week 0 to Week 30 or the time of discontinuation. An assessment after three doses of STNM01 (First: Week 0, Second: Week 2, Third: Week 4) will be performed at Week 6 (Two weeks after the third dose). After the Week 6 assessment, the interval between the assessment and the next dose will be 2 weeks, with this 8-week course defined as 1 cycle. For each participant, administration of STNM01 solution will be continued up to Cycle 4.
In the nal-IRI/FL group, the investigational medical product will be administered from Week 0 to Week 30 or when treatment is discontinued. Treatment will be administered every 2 weeks after the completion of nal-IRI/FL at Week 0 in Cycle 1.
In the STNM01 + nal-IRI/FL group, nal-IRI/FL therapy will be initiated after STNM01 administration at Week 0 in Cycle 1, and every 2 weeks thereafter.
However, if the investigator, etc. determines that treatment is urgent, nal-IRI/FL therapy may be initiated before the first dose of STNM01, after all screening procedures have been performed.

Outcome(s)

• Primary Outcome: Overall survival (OS)

Secondary Outcome

-Progression-free survival (PFS) according to RECIST ver. 1.1, according to the investigator
-Disease control rate (DCR) according to RECIST ver. 1.1, according to the investigator
-Response rate (RR) according to RECIST ver. 1.1, according to the investigator
-Quality of life (QOL) assessment (EORTC-QLQ-C30, EORTC-QOL-PAN26)
-Percentage of CD3, CD8, and glycosyltransferase 15 (CHST15) positive areas by histopathology
-Adverse events
-Tumor markers (CA19-9, CEA)
-Blood CD8, Blood CD33

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable

Include criteria

-Those who have voluntarily signed a written informed consent approved by the Institutional Review Board.
-Those who are 20 years of age or older at the time of acquisition of consent.
-Those whose CD8 positive area ratio was confirmed by the histopathological examination performed at screening.
-Patients with histopathologically confirmed adenocarcinoma and a clinical diagnosis of unresectable advanced pancreatic cancer, including diagnostic imaging. If test results are available prior to the date of informed consent, the results can be used. In addition, if the investigator or subinvestigator (investigator, etc.) diagnosed pancreatic cancer based on a diagnosis made at another medical institution, the results can be used.
-Patients who received first-line chemotherapy using a gemcitabine hydrochloride-associated regimen for unresectable pancreatic cancer and were judged to have been refractory or intolerant.
Note:
--Refractory is defined as evidence of radiological or clinical progression.
--Intolerant is defined as discontinuation of a gemcitabine hydrochloride-associated regimen for reasons such as delayed recovery from adverse events.
-Patients diagnosed with cStageIII or cStageIV according to the General Rules for Pancreatic Cancer, 7th Revised and Enlarged Edition (September 2020) at the time of initial diagnosis.
-Patients with no history of radiotherapy or chemoradiotherapy for the primary disease.
-Patients with at least 1 measurable primary pancreatic lesion with a maximum diameter of => 10 mm at screening. [Conforms to the measurement methods defined in the New Guideline for Evaluation of Therapeutic Response in Solid Tumors (RECIST) version 1.1 guidelines]
-Patients who are scheduled to receive nal-IRI/FL as second-line chemotherapy.
-Patients whose performance status (ECOG PS) is 0 or 1.
-Patients who can take food orally.
-Patients whose laboratory test results at screening meet the following criteria:
--White blood cell count: => 3,000/mm3
--Neutrophil count: => 1,500/mm3
--Platelet count: => 100,000/mm3
--Hemoglobin: => 10 g/dL
--Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): <= 2.5 times the upper limit of normal (<= 5 times the upper limit of normal in patients with liver metastasis)
--Creatinine: <= 2.0 mg/dL
--Creatinine clearance: => 30 mL/min
--Albumin: => 2.5 g/dL
--Serum total bilirubin: <= 1.5 times the upper limit of the normal range
-Patients who are expected to live for at least 2 months from the date of informed consent.
-Patients who are able to comply with the visits and examinations specified in the protocol.

Exclude criteria

-Patients with serious complications (intestinal paralysis, intestinal obstruction, difficult-to-control diabetes mellitus, heart disease, blood disease, lung disease, liver failure, renal failure, etc.). Patients with a serious medical history of serious heart disease, hematologic disease, or pulmonary disease.
-Patients with moderate or severe pleural effusion or ascites.
-Patients with brain metastasis or a history of brain metastasis.
-Patients with a history of malignancy other than pancreatic cancer, except for the following:
--Malignancies that have been treated with the aim of cure, for which an active disease has not been confirmed within 2 years before the randomization date, and which are considered at low risk of recurrence by the investigator, etc.
--Sufficiently treated carcinoma in situ with no signs of disease.
-Patients with active infections.
-Patients with residual adverse events of Grade => 2 due to previous surgery, antineoplastic therapy, etc.
Note: Grades are based on the Common Terminology Criteria for Adverse Events ver. 5.0, translated into Japanese by the Japan Clinical Oncology Group (JCOG) (Common terminology criteria for adverse events (CTCAE) ver. 5.0-JCOG).
-Patients with, or having a history of clinically serious allergies.
-Patients with a bleeding tendency, except for the following:
--Patients who are taking anticoagulants or antiplatelet agents can consider suspension of treatment based on the description of gastrointestinal endoscopy with a high risk of bleeding in the Guideline for Gastrointestinal Endoscopy in Patients Taking Antithrombotic Agents and Supplement 2017 of the Guideline for Gastrointestinal Endoscopy in Patients Taking Antithrombotic Agents on Anticoagulants Including Direct Oral Anticoagulants (DOAC).
-Patients with interstitial lung disease or pulmonary fibrosis.
-Patients who are positive for hepatitis B virus surface (HBs) antigen, hepatitis C virus (HCV) antibody, or a serologic test for syphilis.
-Patients with concomitant autoimmune disease requiring immunosuppressive therapy.
-Patients with psychosis or psychiatric symptoms, for whom participation in the study is considered difficult.
-Patients for whom the testing specified in the protocol is impossible or restricted.
-Women who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the study.
-Men who wish to have children or donate sperm during the study period.
-Fertile men and female participants who do not intend to use contraception under the guidance of the investigator during the treatment period.
-Those who are currently participating in or plan to participate in other clinical trials during the study period (non-interventional observational studies are allowed). Patients who received another study drug within 28 days before randomization.
-Patients who have received STNM01 in the past.
-Patients who are deemed ineligible to participate in the study by the investigators.

Related Information

• Primary Sponsor: Hiroyuki Yoneyama