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

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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)

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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