OMT-111 for Terminal Stage Solid Tumors

NCT04520386 | Unknown Phase 2

• 1 other identifier: Metimedi-202
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

Brief Summary

Patients with terminal stage of metastatic non-small cell lung cancer, metastatic triple negative breast cancer, or advanced or metastatic pancreatic adenocarcinoma resisting to standard therapies.

Conditions

Breast Cancer; Pancreatic Cancer; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate (DCR)

  Every two cycles (8 weeks)

  From the start of treatment to 48 weeks.

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  From the start of treatment to 48 weeks.

• Duration of Response (DoR)

  From the start of treatment to 48 weeks.

• Progression-Free Survival (PFS)

  From the start of treatment to 48 weeks.

• 18F-FDG- PET/CT (SUVmean and SUVmax)

  From the start of treatment to 48 weeks.

Study Arms (1)

Open label single arm

EXPERIMENTAL

1 cycle consists of 4 weeks (28 days). Each week consists of 5 days of treatment and 2 days of treatment-free interval

Drug: OMT-111

Interventions

OMT-111 DRUG

Pre-filled Syringe

Also known as: OMT-110

Open label single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast Cancer
• Female at least 18 years old or older at the time of informed consent
• Histologically or cytologically confirmed triple negative ductal adenocarcinoma of breast
• Patients who have visceral metastatic lesions not amenable by resection or radiotherapy (e.g., multiple visceral lesions)
• ECOG PS (Eastern Cooperative Oncology Group Performance Status): 0-2
• Patients with a life expectancy ≥ 12 weeks as judged by the investigator
• At least one measurable lesion or evaluable lesion defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• Pancreatic Cancer
• Male or female at least 18 years old or older at the time of informed consent
• Histologically or cytologically confirmed adenocarcinoma of pancreas
• Patients who have advanced or metastatic lesions not amenable by resection or radiotherapy
• ECOG PS (Eastern Cooperative Oncology Group Performance Status) ≤ 2
• Patients with a life expectancy ≥ 12 weeks as judged by the investigator
• At least one measurable lesion or evaluable lesion defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• Lung Cancer

You may not qualify if:

• Breast Cancer
• History of malignancy other than metastatic triple negative breast 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)
• Uncontrolled CNS metastasis (however, patients with treated and stable brain metastasis (radiographically stable for at least 30 days without steroids) are eligible)
• Primary cancer-related complications potentially requiring urgent surgery as judged by the investigator
• Grade ≥ 3 active infection requiring intravenous antibiotics per NCI-CTCAE version 5.0
• History of one or more of the following cardiovascular diseases
• Cerebrovascular disease, unstable angina, or myocardial infarction within 6 months prior to the screening visit (Visit 1)
• Congestive heart failure corresponding to New York Heart Association (NYHA) Class III or above (see Appendix 1. NYHA Classification)
• Serious cardiac arrhythmia not controlled with medication or clinically significant cardiovascular abnormality as judged by the investigator
• QTc \> 480 msec (Fredericia's formula) during 12-lead ECG at screening visit (Visit 1)
• Pregnant women, breast-feeding women or women with a positive pregnancy test at screening visit (Visit 1)
• Renal impairment or chronic renal failure patient requiring hemo- or peritoneal dialysis
• Previous treatment with the investigational product
• Treatment with other investigational product within 30 days prior to the first dose of the investigational product
• Unable to come to the site hospital on a daily basis for investigational product administration

Sponsors & Collaborators

• MetiMedi Pharmaceuticals: lead

Study Sites (2)

K Hospital

Hanoi, Vietnam

Location

Cho Ray Hospital

Hochiminh City, Vietnam

Location

MeSH Terms

Conditions

Breast Neoplasms; Pancreatic Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Soobong Park

  MetiMedi Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

DongChul Kim

CONTACT

84-93-510-7310; dongchool.kim@bigleapresearch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 20, 2020
• Study Start: October 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: October 1, 2022
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)