A Phase IIa Study to Evaluate the Efficacy of OMT-111 in Patients with Metastatic Colorectal Cancer Resistant to Standard Therapies

Not Applicable

Recruiting

• Conditions: Diseases of the digestive system

• Registration Number: KCT0005343
• Lead Sponsor: MetiMedi Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1)Male or female at least 19 years old or older at the time of informed consent
2)Histologically or cytologically confirmed carcinoma of the Colorectal
3)Patients who have unresectable metastatic lesion
4)ECOG PS (Eastern Cooperative Oncology Group Performance status) = 2
5)Patients with a life expectancy = 12 weeks as judged by the investigator
6)At least one measurable lesion or evaluable lesion defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
7)Voluntarily provided written consent to participate in this study

Exclusion Criteria

1)History of malignancy other than metastatic colorectal cancer within 5 years prior to the first dose of investigational product (however, patients with effectively treated skin cancer, thyroid cancer, and carcinoma in situ that has been in complete remission for at least 3 years and thus considered cured by the investigator are eligible)
2)Uncontrolled CNS metastasis (however, patients with treated and stable brain metastasis (radiographically stable for at least 30 days) are eligible)
3)Primary cancer-related complication potentially requiring urgent surgery as judged by the investigator
4)Grade = 3 active infection requiring intravenous antibiotics per NCI-CTCAE version 5.0
5) Pregnant women, breast-feeding women or women with a positive pregnancy test at screening visit (Visit 1)
6)Previous treatment with the investigational product
7)Treatment with other investigational product within 30 days prior to the first dose of the investigational product
8)Patients who are otherwise considered to be ineligible for this study based on investigator’s judgment

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease control rate, DCR

Secondary Outcome Measures

Name	Time	Method
Objective response rate, ORR;Duration of Response (DoR);Progression-Free Survival (PFS);18F-FDG- PET/CT (SUVmean and SUVmax)