Phase 1
Completed N=24
A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer
Source: ClinicalTrials.gov NCT01801930 ↗Enrolled (actual)
24
Serious AEs
33.3%
Results posted
Feb 2021
Primary outcomePrimary: Dose Limiting Toxicity (DLT) — 0; 0; 0; 0 participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Limiting Toxicity (DLT) |
0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With CTCAE Grade 3 or Higher TEAEs |
3; 4; 1; 3 | — |
| SECONDARY Tumor Response Rate in Cycle 1 |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01801930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.