An investigator-initiated, phase II clinical trial of the peptide-based cancer vaccine targeting WT1, DSP-7888, for colorectal adenomas in familial adenomatous polyposis

JRCT ID: jRCT2051200082

Registered date:06/11/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: familial adenomatous polyposis
• Date of first enrollment: 04/12/2020
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Induction phase: intradermal administration of DSP-7888 dosing emulsion 3.5mg once every 14 days for 2 months (5 times in total)
Maintenance phase: intradermal administration of DSP-7888 dosing emulsion 3.5mg once every 28 days for 6 months (6 times in total)

Outcome(s)

• Primary Outcome: Percentage of patients with newly detected polyps of >=5 mm in diameter in the colon and/or rectum

Secondary Outcome

(1)Clinical efficacy
- Macroscopic changes of polyps, such as diameter and height, at the target areas of the colon and rectum
- Changes in the number of polyps >=2.5 mm in diameter at the target areas of the colon and rectum
(2)Safety
- Incidence of adverse reactions
- Incidence of adverse events
(3)Immune response
- WT1-specific cellular immunity
- WT1-specific humoral immunity

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 50age old
• Gender: Both

Include criteria

1) Patients diagnosed familial adenomatous polyposis (FAP) with more than 100 colorectal adenomas and a presence of disease-causing mutation of the APC gene.
2) 20 - 50 years old on the date of consent.
3) ECOG-PS 0 -1.
4) No polyps larger than 5 mm in diameter in the colon and rectum.
5) Patients who have undergone endoscopic observation for at least 2 years after diagnosis of FAP.
6) Patients with intact colons and rectums. (Any history of appendectomy or endoscopic polypectomy does not matter)
7) Patients who have not regularly taken nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin and sulindac, within 6 months before enrollment.
8) The most recent test values within 28 days before enrollment meet the criteria in the protocol.
9) Patients who have given written consent voluntarily to participate in this study.

Exclude criteria

1) Patients with active malignancies.
2) Patients with a history of allergy to oily products.
3) Patients with infections requiring systemic treatment.
4) Patients with uncontrolled comorbidities (cardiovascular diseases, respiratory diseases, renal diseases, liver diseases, hematologic diseases, skin diseases, etc.).
5) Patients with diseases requiring oral or intravenous administration of corticosteroid or immunosuppressants.
6) Patients with symptomatic or active autoimmune diseases, except for autoimmune thyroid diseases such as Graves' disease and Hashimoto's disease, endocrine diseases manageable with appropriate hormone replacement therapies, and type1 diabetes manageable with insulin replacement.
7) Patients positive for HBs antigen, for HBV-DNA with HBc-antibody-positive or HBs-antibody-positive, or for HCV antibody.
8) Patients positive for HIV antibody.
9) Patients who have been participating in other clinical studies, except for an observational study, at the enrollment or who received other investigational products within 6 months before enrollment.
10) Women who are pregnant, possibly pregnant (ex. positive pregnancy test), within 28 days postpartum, or breastfeeding (possible to enroll if she can stop breastfeeding from the first administration of the study drug until 180 days after the last administration of the study drug) or patients and their partners have no intention of contraception from the date of consent until 180 days after the last administration of the study drug.
11) Patients who are considered difficult to participate in the study, because of mental disorders or a mental condition that interfere with daily activities.
12) Patients deemed inappropriate by the investigator.

Related Information

• Primary Sponsor: Shichijo Satoki
• Secondary Sponsor: Nishida Sumiyuki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development