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

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: OCV-103 and OCV-104; Drug: OCV-103 and OCV-104; Drug: OCV-103 and OCV-104; Drug: OCV-103 and OCV-104

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Nagoya, Japan
  • Sunto-gun, Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose level 1	Drug: OCV-103 and OCV-104; 0.3 mg of each; Drug: OCV-103 and OCV-104; 1 mg of each; Drug: OCV-103 and OCV-104; 3 mg of each; Drug: OCV-103 and OCV-104; 6 mg of each
Experimental: Dose level 2	Drug: OCV-103 and OCV-104; 0.3 mg of each; Drug: OCV-103 and OCV-104; 1 mg of each; Drug: OCV-103 and OCV-104; 3 mg of each; Drug: OCV-103 and OCV-104; 6 mg of each
Experimental: Dose level 3	Drug: OCV-103 and OCV-104; 0.3 mg of each; Drug: OCV-103 and OCV-104; 1 mg of each; Drug: OCV-103 and OCV-104; 3 mg of each; Drug: OCV-103 and OCV-104; 6 mg of each
Experimental: Dose level 4	Drug: OCV-103 and OCV-104; 0.3 mg of each; Drug: OCV-103 and OCV-104; 1 mg of each; Drug: OCV-103 and OCV-104; 3 mg of each; Drug: OCV-103 and OCV-104; 6 mg of each

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Limiting Toxicity (DLT)	[Definition of DLT] Any of the following adverse events (AEs) that occurred by Day 29 of Cycle 1 and for which a causal relationship to OCV-C02 could not be ruled out: Grade 3 or higher non-hematological toxicities (except for injection site reaction and laboratory abnormalities lasting < 7 days without clinical symptoms); The following hematological toxicities: Grade 4 or higher anemia, Grade 4 or higher neutropenia or lymphocytopenia lasting 7 days, Grade 3 or higher febrile neutropenia, Grade 4 or higher platelet count decreased. The severity of AEs was graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Japanese version). In addition, a DLT-equivalent treatment-emergent adverse event (TEAE) was defined as a DLT occurred during the extend treatment period (at Cycle 2 and thereafter).	Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With CTCAE Grade 3 or Higher TEAEs	The severity (grade) of an AE was evaluated using the 5-point scale from Grade 1 to Grade 5 in accordance with CTCAE version 4.0 (Japanese version) , where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe or medically significant but not immediately life-threatening; Grade 4 = Life-threatening consequences; Grade 5 = Death related to AE.	From the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
Tumor Response Rate in Cycle 1	Tumor response was graded in accordance with the new Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Complete Response (CR): Disappearance of all target lesions (any malignant lymph nodes selected as target lesions must have a reduction in the minor axis to <10 mm) Partial Response (PR): At least a 30% decrease in the diameter sum of the target lesions as compared with the diameter sum at screening Progressive Disease (PD): At least a 20% increase in the diameter sum of the target lesions as compared with the smallest diameter sum recorded after the start of treatment, and at least 5 mm increase in the absolute increase of at least 5 mm Stable Disease (SD): Neither tumor shrinkage equivalent to PR nor tumor enlargement equivalent to PD Not Evaluable (NE): No examination is feasible or the tumor response cannot be considered as any of CR, PR, PD, and SD	Day 29

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Investigators: Study Director: Junichi Hashimoto, PhD, Otsuka Pharmaceutical Co., Ltd.

Publications and helpful links

General Publications

• Taniguchi H, Iwasa S, Yamazaki K, Yoshino T, Kiryu C, Naka Y, Liew EL, Sakata Y. Phase 1 study of OCV-C02, a peptide vaccine consisting of two peptide epitopes for refractory metastatic colorectal cancer. Cancer Sci. 2017 May;108(5):1013-1021. doi: 10.1111/cas.13227. Epub 2017 May 11.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: February 27, 2013
• First Submitted That Met QC Criteria: February 27, 2013
• First Posted (Estimate): March 1, 2013

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Antigen specific cancer immunotherapeutic; OCV-C02
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 293-12-001; JapicCTI-132075 (Other Identifier: Japic)