64Cu-NCAB001 in patients with pancreatic cancer

JRCT ID: jRCT2031230311

Registered date:29/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic cancer without clinically distant metastasis
• Date of first enrollment: 01/09/2023
• Target sample size: 18
• Study type: Interventional
• Intervention(s): A single dose of 64Cu-NCAB001 is administered intraperitoneally under endoscopic ultrasound.

Outcome(s)

• Primary Outcome: Dose Limiting Toxicity (DLT) expression rate (CTCAE v5.0-JCOG)

Secondary Outcome

- Adverse event expression rate (CTCAE v5.0-JCOG)
- Adverse reaction (side effect) due to the investigational product (CTCAE v5.0-JCOG)
- Adverse reaction (side effect) due to EUS (CTCAE v5.0-JCOG)
- Adverse reaction (side effect) due to EUS-FNA (CTCAE v5.0-JCOG)
- Adverse reaction (side effect) due to intraperitoneal administration (CTCAE v5.0-JCOG)
- Adverse event expression rate (Lexicon classification)
- Adverse reaction (side effect) due to EUS (Lexicon classification)
- Adverse reaction (side effect) due to EUS-FNA (Lexicon classification)
- Adverse reaction (side effect) due to intraperitoneal administration (Lexicon classification)
- Presence or absence of abnormal accumulation of investigational product
- Effective radiation dosage at each dose level
- Absorbed radiation dosege in each organ
- Pharmacokinetic parameters: t1/2, AUC, urinary radioactivity excretion rate, and evaluation of dissocation of 64-Cu ion from antibody in blood and urine

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old

Include criteria

1) Contrast-enhanced CT shows typical imaging findings such as pancreatic mass/dilation of the caudal pancreatic duct with low absorption area, and as a result of diagnostic imaging, it shows strong clinical suspicion of pancreatic cancer due to such as elevation tumor maker (CA19-9). However, the participant has regional lymph node metastasis around the primary tumor and is diagnosed as resectable or resectable borderline pancreatic cancer, is eligible
2) Schedluded for cytological or histoligical diagnosis with EUS
3) Age at registration is between 18 and 80 years
4) Performance Status (ECOG) is 0 or 1
5) Not receieved surgical resection, chemotherapy, or radiation therapy (including gamma knife and cyber knife) for pancreatic or gastrointestinal cancer
6) Having all laboratory tests performed within 14 days before registration and the values are within the following range. Howerber, participants should not recieve administration of blood transfusion within 14 days before the blood collection.
(1) White blood cells count >= 3,500 /mm3
(2) Hemoglobin >=9.0 g/dL
(3) Platelet count >=100,000 /mm3
(4) Albmine >=3.0 g/dL
(5) Aspartate aminotransferase (AST) <=100 U/L and Alanine aminotransferase (ALT) <=100 U/L ( <=150
U/L with bile duct drainage)
(6) Total bilirubin <=2.0 mg/dL (<=3.0 mg/dL with bile duct drainage)
(7) Serum creatinine <=1.2 mg/dL
(8) PT-INR <=1.5
7) Consent to at least 4 months of restriction of breastfeeding for lactating participant, and consent to
at least 4 months of contraception(*) from the start of administration with investigational product
for male participant.
*Contraceptive method: Dual contraception by any two of the following: condom, oral contraceptive pills, or intrauterine device. However, implanted contraceptive devices, pessaries (including those with sprmicide), cervival caps with spermicides, and contraceptive sponges (including spermicides) are disable because of not approved or certified in Japan.
8) Written informed consent

Exclude criteria

1) Participants with a strong clinical suspicion of pancreatic cancer but unresectable (with locally advanced or distant metastasis) by contrast-enhanced CT performed within 14 days prior to the date of registration
2) Active double primary cancer (but not (1)-(3)): (1) completely resected following cancers: basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, (2) gastrointestinal cancer curatively resected with ESD or EMR, and (3) other cancers with no recurrence for more than 5 years.)
3) Participants with infections requiring systemic treatment.
4) Previous serious(*) hypersensitive reaction or allergy to CT contraset agent, cetuximab, or component of investigational product
5) Participants with complications or history of interstitial pneumonia or pulmonary fibrosis diagnosed by imaging or clinical findings
6) Participants with ascites or pleural effusion that exceeds the physiological range
7) Participants with uncontrolled diabetes mellitus, serious(*) heart disease, angina pectoris, history of myocardial infarction within 3 months prior to the date of registration, serious(*) hepatic disorder, or serious(*) phychiatric disease
8) Female participants who are pregnant or may become pregnant : Non-menopausal female particiapants who have not undergone surgical sterlization (hysterectomy or bilateral oophorectomy). Menopause is defined as her 12 months or longer without menstruation without other medical reasons such as medication.
9) Participants who are judged by the investigator or sub-investigator to be unsuitable for the trial due to medical, psychological or other factors
*: "serious" is defined as Grade 2 in the "Criteria for Classifying Seriousness of Adverse Drug Ractions (Notification No. 80 of the Safety Division of the Pharmaceutical Affairs Bureau, Ministry of Health and Welfare dated June 29, 1992)".
https://www.mhlw.go.jp/shingi/2005/10/dl/s1006-4f2.pdf

Related Information

• Primary Sponsor: Hijioka Susumu
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development