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

Otsuka

Status and phase: Completed; Phase 1

Conditions: Colorectal Cancer

Treatments: Drug: OCV-103 and OCV-104

Study type: Interventional

Funder types: Industry

Identifiers

NCT01801930

JapicCTI-132075 (Other Identifier)

293-12-001

Details and patient eligibility

About

To assess the safety and tolerability of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapy

Full description

The incidence of dose limiting toxicity (DLT) will be evaluated in cohorts of six patients by starting OCV-C02 administration at dose level 1 (OCV-103 and OCV-104 at 0.3 mg each), increasing the dose to dose level 2 (at 1 mg each), level 3 (at 3 mg each), and then up to dose level 4 (at 6 mg each). Once-weekly administration will be repeated four times in each treatment cycle, and the incidence of DLT from Day 1 to Day 29 will be evaluated.

At the end of Cycle 1, patients who wish to continue OCV-C02 treatment and have provided their written consent will be permitted to continue participation in the trial using the same dosing schedule for each subsequent cycle as that for Cycle 1.

Enrollment: 24 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients who are HIV antibody test positive
• Patients with an active infection
• Patients who have or are suspected to have CNS metastasis of colon cancer (such as metastatis of the brain)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Dose level 1

Experimental group

Treatment:

Drug: OCV-103 and OCV-104

Dose level 2

Experimental group

Treatment:

Drug: OCV-103 and OCV-104

Dose level 3

Experimental group

Treatment:

Drug: OCV-103 and OCV-104

Dose level 4

Experimental group

Treatment:

Drug: OCV-103 and OCV-104