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Advanced Solid TumorPhase 1NCT03272256

Phase 1 Study of IM156 in Patients With Advanced Solid Tumor and Lymphoma

A Phase 1 study testing IM156 in people with Advanced Solid Tumor, run by ImmunoMet Therapeutics, Inc. at 3 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of first-in-human IM156 study is to evaluate the safety and tolerability, and to determine the maximum tolerated dose and recommended phase 2 dose of IM156. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
IM156
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
3 sitesSouth Korea
Study dates
9 Oct 2017to 28 Jul 2020
Phase
Phase 1
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged at least 19 years old.
  • Patients histologically or cytologically diagnosed with advanced solid tumor.
  • Patients for whom no standard therapies are available or who have failed in the existing conventional therapies.
  • Patients with a measurable or evaluable lesion by the RECIST v1.1 [for patients with recurrent glioblastoma, the RANO guideline is applied].
  • Patients with the Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
  • Patients with the adequate function of bone marrow, kidney and liver as follows.
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  • ① Absolute Neutrophil Count ≥ 1,500/mm³, Platelet ≥ 100,000/mm³, Hemoglobin ≥ 9.0 g/dL (In case of hemoglobin < 9.0 g/dL, the patient can be enrolled if the value is reversed to ≥ 9.0 g/dL. However, blood transfusion to meet this criterion within 1 week is not allowed.)
  • ② Serum creatinine ≤ 1.5 X upper limit of normal (ULN)
  • ③ Total bilirubin ≤ 1.5 X UNL, AST, ALT ≤ 3 ×ULN (for patients with liver disease ≤ 5 ×ULN)
  • ④ Fasting serum glucose ≤ 160 mg/dL
  • Patients with the life expectancy ≥ 12 weeks.
  • Patients who have agreed to use acceptable methods for contraception during the study treatment period.
  • (e.g.: sterilization of the patient and his/her partner, intrauterine device of the partner, barrier contraception, combination with diaphragm or condom)
  • Patients who have voluntarily signed an informed consent to participate in this clinical study.

Who cannot join

  • Patients with a history of hypersensitivity to the active ingredient or any component of the investigational product or biguanides.
  • Patients with a current evidence of diabetes mellitus who are currently being treated with another biguanide (e.g., metformin)
  • Patients with a history of serious gastrointestinal bleeding within 6 weeks prior to screening or patients with any disease possibly affecting the absorption of oral agents. (malabsorption syndrome, hemorrhagic gastric ulcer, etc.)
  • At the time of screening,
  • For patients who underwent major surgery, at least 4 weeks have not elapsed after surgery.
  • For patients who underwent radiotherapy, at least 3 weeks have not elapsed from the last treatment day.
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  • For patients who underwent chemotherapy, at least 3 weeks have not elapsed from the last treatment day. (6 weeks for nitrosurea compounds).
  • For patients treated with biologic agents including hormone therapy, at least 5 half-lives or 3 weeks, whichever is shorter.
  • Patients who have not been recovered from the toxicities to grade 1 of the therapy received prior to screening.
  • Pregnant women or nursing mothers.
  • Patients who were administered another investigational product within 3 weeks prior to screening.
  • Patients with uncontrolled metastasis to the central nervous system. However, patients with treated and stable brain metastases (stable at least for 30 days on radiology imaging) are allowed to enroll.
  • Patients with suspected serious infectious diseases, intestinal paralysis, bowel obstruction, interstitial pneumonia, or pulmonary fibrosis.
  • Patients with a history of psychiatric disorders likely to threaten the compliance with this protocol.
  • Patients with a history of alcohol or drug abuse within 12 weeks prior to screening.
  • Human Immunodeficiency Virus (HIV) infection or active hepatitis B or C. Patients with no detectable viral load could be enrolled.
  • Patients with severe traumatism.
  • Patients with any clinically significant abnormal intestinal findings that may interfere with the administration, passage, or absorption of the investigational product, which makes the patients unable to orally take the tablet form of drugs.
  • Patients with severe cardiac disorders (e.g. myocardial infarction, congestive heart failure, arrhythmia showing dramatic change in electrocardiogram (ECG), severe or unstable angina, other serious cardiac disorders) or patients with comorbidities of other serious internal disorders (e.g. uncontrolled diabetes mellitus, chronic obstructive pulmonary disorder, renal failure, etc.) on investigator's judgment.
  • Patients who are otherwise considered to be ineligible for this study on investigator's judgment.

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • CHA Bundang Medical Center

    Seongnam-si, Gyeonggi-do, 13496

  • Asan Medical Center

    Seoul

  • Yonsei University Severance Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Multi Center, Open-label, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IM156 in Patients With Advanced Solid Tumors and Lymphoma

The main purpose of first-in-human IM156 study is to evaluate the safety and tolerability, and to determine the maximum tolerated dose and recommended phase 2 dose of IM156.

Being tested
IM156

What participants receive

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

  • IM156Drug

    Sequential 3+3 design.

Study groups in NCT03272256
Study groupRoleWhat they receive
IM156, Dose escalationExperimentalNot described
Receives: Drug: IM156

What is being measured

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

  1. Dose Limiting Toxicity (DLT)

    Evaluate the safety and tolerability to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)

    Measured: 4 weeks

Secondary outcomes (8)

  1. Maximum plasma concentration (Cmax)

    Measured: 4 weeks

  2. Time to Cmax (Tmax)

    Measured: 4 weeks

  3. Area under the curve (AUC)

    Measured: 4 weeks

  4. Plasma half life (T1/2)

    Measured: 4 weeks

  5. Volume of distribution (V/F)

    Measured: 4 weeks

  6. Plasma Clearance (CL/F)

    Measured: 4 weeks

  7. Exploratory Surrogate Biomarker

    Explore potential surrogate biomarkers in peripheral blood mononuclear cells (PBMC).

    Measured: 2 weeks

  8. Preliminary tumor response

    Assess objective tumor response and progression based on the Response Evaluation Criteria for Solid Tumor (RECIST) v1.1 [for patients with recurrent glioblastoma, the Response Assessment in Neuro-Oncology (RANO) guideline is applied].

    Measured: Every 8 weeks up to end of treatment (EOT)

Timeline

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

  1. First posted5 Sep 2017
  2. Study start9 Oct 2017
  3. Primary completion2 Dec 2019
  4. Study completion28 Jul 2020

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03272256
Sponsor's protocol ID
IM_IM156-01
Status last verified
Oct 2020
First submitted
29 Aug 2017
Last updated
19 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IM156 in people with Advanced Solid Tumor, run by ImmunoMet Therapeutics, Inc. at 3 sites in South Korea.

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 14 inclusion and 20 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: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (DLT) (time frame: 4 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 NCT03272256.

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 19 Oct 2020.

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