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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: OCV-103 and OCV-104
* Drug: OCV-103 and OCV-104
* Drug: OCV-103 and OCV-104
* Drug: OCV-103 and OCV-104


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCV-C02, Colorectal Cancer, Antigen specific cancer immunotherapeutic