A Phase I Study to Assess the Safety, Tolerability and Potential Therapeutic Dose of OMT-110 in Patients with metastatic colorectal cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0005336

Enrollment

Registered

2020-08-24

Start date

2017-10-09

Completion date

Unknown

Last updated

2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : The clinical trial is a traditional 3+3 method in which three or six subjects are registered per dose group, increased to the specified dose up to stage 4, and the maximum tolerated dose (MTD)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Male or female at least 20 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

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability	—

Secondary

Measure	Time frame
pharmacokinetic properties;tumor response evaluation	—

Countries

Korea, Republic of

Contacts

Public ContactSeung-Il BAEK

MetiMedi Pharmaceuticals

Outcome results