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Breast CancerPhase 2NCT04520386

OMT-111 for Terminal Stage Solid Tumors

A Phase 2 study testing OMT-111 in people with Breast Cancer and Pancreatic Cancer, run by MetiMedi Pharmaceuticals at 2 sites in Vietnam.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Pancreatic Cancer, Lung Cancer
What is being tested?
OMT-111
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
2 sitesVietnam
Study dates
Oct 2020to Oct 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 21Show fewer
  • 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
  • Male or female at least 18 years old or older at the time of informed consent
  • Histologically or cytologically confirmed carcinoma of the lung (small cell lung cancer not included)
  • Patients who have unresectable metastatic lesion
  • 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

Who cannot join

  • 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
Show all 48Show fewer
  • 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
  • Patients who are otherwise considered to be ineligible for this study based on investigator's judgment.
  • Pancreatic Cancer
  • History of malignancy other than advanced or metastatic pancreatic adenocarcinoma 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 complication 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
  • Patients who are otherwise considered to be ineligible for this study based on investigator's judgment
  • Lung Cancer
  • History of malignancy other than metastatic non-small cell lung 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) are eligible)
  • Primary cancer-related complication 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
  • Patients who are otherwise considered to be ineligible for this study based on investigator's judgment

Trial locations and contacts

2 sites in 1 country.

DongChul Kim contact

84-93-510-7310

dongchool.kim@bigleapresearch.com

Vietnam2 sites

  • K Hospital

    Hanoi

    Dao Van Tu

  • Cho Ray Hospital

    Hochiminh City

    Le Tuan Anh

Other trials in Vietnam

About this study

Official title: A Multi-site, Single Arm, Phase II Clinical Trial, to Evaluate the Efficacy of OMT-111 in Supporting the Treatment of Terminal Stage Solid Tumors

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.

Read the detailed description

This is a multi-site, single arm, Phase II study designed to explore the efficacy of OMT-111 in patients with terminal stage solid tumors resistant to standard therapies.

Subjects who voluntarily provide written consent to participate in this study undergo screening tests within 4 weeks prior to the first dose of investigational product. Those who meet the inclusion/exclusion criteria are enrolled in the study.

1 cycle consists of 4 weeks (28 days). Each week consists of 5 days of treatment and 2 days of treatment-free interval (20 days of treatment and 8 days of treatment-free interval per cycle in total). This study is planned to enroll approximately 76 subjects including 42 subjects with lung cancer, 22 subjects with breast cancer, and 12 subjects with pancreatic cancer. Treatment will be provided for 12 cycles (48 weeks). During the study, tests and procedures to evaluate the efficacy and safety will be carried out according to the planned schedule.

Being tested
OMT-111
Medical subject headings
Breast Neoplasms, Pancreatic Neoplasms, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OMT-111Drug

    Also called OMT-110

    Pre-filled Syringe

Study groups in NCT04520386
Study groupRoleWhat they receive
Open label single armExperimental1 cycle consists of 4 weeks (28 days). Each week consists of 5 days of treatment and 2 days of treatment-free interval
Receives: Drug: OMT-111

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Control Rate (DCR)

    Every two cycles (8 weeks)

    Measured: From the start of treatment to 48 weeks.

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    Every two cycles (8 weeks)

    Measured: From the start of treatment to 48 weeks.

  2. Duration of Response (DoR)

    Every two cycles (8 weeks)

    Measured: From the start of treatment to 48 weeks.

  3. Progression-Free Survival (PFS)

    Every two cycles (8 weeks)

    Measured: From the start of treatment to 48 weeks.

  4. 18F-FDG- PET/CT (SUVmean and SUVmax)

    Every two cycles (8 weeks)

    Measured: From the start of treatment to 48 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2020
  2. Study startOct 2020 (estimated)
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completionOct 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04520386
Sponsor's protocol ID
Metimedi-202
Status last verified
Sep 2020
First submitted
12 Aug 2020
Last updated
9 Sep 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OMT-111 in people with Breast Cancer and Pancreatic Cancer, run by MetiMedi Pharmaceuticals at 2 sites in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact DongChul Kim (84-93-510-7310, dongchool.kim@bigleapresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Control Rate (DCR) (time frame: From the start of treatment to 48 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04520386.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.

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OMT-111 for Terminal Stage Solid Tumors (NCT04520386) | AzTrials