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A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer

A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapy

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222029
Enrollment
24
Registered
2013-02-22
Start date
2013-03-12
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 or Relapsed Colorectal Cancer

Interventions

investigational material(s) Generic name etc : OCV-C02 INN of investigational material : - Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material

Sponsors

Otsuka Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Patients who have human leukocyte antigen (HLA)-A*24:02 - Patients with histologically confirmed colorectal cancer (adenocarcinoma) - Patients with advanced or relapsed colorectal cancer who are refractory or intolerant to standard chemotherapy - Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 at the time of study enrollment

Exclusion criteria

Exclusion criteria: - Patients who are HIV antibody positive - Patients with an active infection - Patients who have or are suspected to have CNS metastasis

Design outcomes

Primary

MeasureTime frame
safety Dose Limiting Toxicity (DLT) Common Terminology Criteria for Adverse Events (CTCAE), ver. 4.0

Secondary

MeasureTime frame
safety Safety Common Terminology Criteria for Adverse Events (CTCAE), ver. 4.0 efficacy Tumor response Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1 efficacy Immune-response DTH reactions, CTL Measurement, Blood Regulatory T Cell Measurement

Countries

Japan

Outcome results

None listed

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