A phase I study of cancer vaccine with CHP-MAGE-A4 in patients with advanced cancers expressing MAGE-A4 antigen

A phase I study of cancer vaccine with CHP-MAGE-A4 in patients with advanced cancers expressing MAGE-A4 antigen - CHP-MAGE-A4 cancer vaccine

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003188

Enrollment

Registered

2010-02-15

Start date

2009-09-01

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 esophageal cancer, stomach cancer, non-small cell lung cancer (NSCLC), colon cancer.

Interventions

CHP-MAGE-A4 300microgram Every 2 weeks x 6 times

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histological diagnosis of any type of cancers expressing MAGE-A4 antigen. 2.Advanced cancer patient. 3.Performance status of 0-2. 4.Age over 20 years. 5.At least 4 weeks since radiotherapy, biological therapy, chemotherapy or surgery prior to first dosing of study agent. 6.Life expectancy > 4 months. 7.Laboratory values within the following limits: WBC > 2000/mm3 Hemoglobin> 8.0 g/dL Platelet count > 75,000/mm3 Serum bilirubin < 2.0 mg/dl AST,ALT < 150 IU/l Serum creatmine < 2.5 mg/dL 9.Able and willing to give witnessed, written informed consent for participation in the trial

Exclusion criteria

Exclusion criteria: 1.Other serious illnesses. 2.History of immunodeficiency disease or autoimmune disease. 3.Metastatic disease to the central nervous system, unless treated and stable. 4.Other malignancy 5.Known HIV, positivity. 6.Concomitant treatment with steroids. 7.Pregnancy or lactation. 8.Lack of availability of the patient for immunological and clinical follow-up assessment.

Design outcomes

Primary

Measure	Time frame
Toxicities and adverse events defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale. NY-ESO-1 specific immunity.	—

Secondary

Measure	Time frame
Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST).	—

Countries

Japan

Contacts

Public ContactHisashi Wada

Osaka University Graduate School of Medicine Department of Surgery

hwada@gesurg.med.osaka-u.ac.jp06-6879-3251

Outcome results

None listed

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