Phase I study safety and immunogenicity of vaccination with XAGE1 long peptides in patients with advanced lung adenocarcinoma

Phase I study safety and immunogenicity of vaccination with XAGE1 long peptides in patients with advanced lung adenocarcinoma - XAGE1 cancer vaccine against advanced lung adenocaricinoma

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026493

Enrollment

Registered

2017-05-22

Start date

2017-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced lung adenocarcinoma

Interventions

XAGE1 cancer vaccine 0.5mg will be administered 4 times every 2 week. XAGE1 cancer vaccine 1mg will be administered 4 times every 2 week. XAGE1 cancer vaccine 2mg will be administered 4 times every 2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)XAGE1 expression or XAGE1 antibody positive advanced lung adenocarcinoma (2)Patients with refractory or intolerable to standard therapy, patients who have no standard therapy or refuse standard therapy. (3)Performance status 0-2 (4)Patients should be 20 years or older at informed consent. (5)patients did not received anticancer agent, immune suppressant, immune enhancer, cytokine therapy, radiotherapy or surgery for the primary disease within 4 weeks. (6)Life expectancy >= 3 months (7) No serious disorder of major organs (bone marrow, heart, lung, liver and kidney) and meet the following conditions. 1) WBC count: >=1,500/mm3 2) Hemoglobin: >=8.0g/dL 3) Platelet count: >=100,000/mm3 4) Serum total bilirubin: <=1.5 x ULN 5) AST and ALT: <=2.5 x ULN 6) Serum creatinine: <=1.5 mg/dL (8)Given written informed consent. (9)Without the history of penicillin hypersensitivity.

Exclusion criteria

Exclusion criteria: (1) Patients with HIV antibody positive. (2) Patients with HCV antibody positive. (3) Patients with HBs antigen or HBV-DNA positive. (4) Patients with active autoimmune disease. (5) History of serious anaphylaxis induced by antibody preparation. (6) Within 4 weeks after treatment with anticancer agent, immune suppressant, immune enhancer, cytokine therapy, radiotherapy or surgery for the primary disease. (7) Patients with double cancer. (8) Patients who need continuous systemic administration of adrenocorticosteroid. (9) Refuse to use birth control including condom etc. from the time of obtaining the first consent to 24 weeks after the final administration of the study drug (except female after menopause (1 year or more after the last menstruation) and female/male after the operation for sterilization). (10) Patients with active infection. (11) Patients with psychosis or dementia. (12) Patients who have received hematopoietic stem cell transplantation. (13) Any other inadequacy for this study.

Design outcomes

Primary

Measure	Time frame
Adverse events	—

Secondary

Measure	Time frame
XAGE1 antibody respose	—

Countries

Japan

Contacts

Public ContactKOJI KUROSE

Secretariat of clinical trial coordinating committee (none)

kuro-ko.66@med.kawasaki-m.ac.jp086-462-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026