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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03272256
Recruitment Status : Completed
First Posted : September 5, 2017
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
ImmunoMet Therapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: IM156 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 9, 2017
Actual Primary Completion Date : December 2, 2019
Actual Study Completion Date : July 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: IM156, Dose escalation Drug: IM156
Sequential 3+3 design.




Primary Outcome Measures :
  1. Dose Limiting Toxicity (DLT) [ Time Frame: 4 weeks ]
    Evaluate the safety and tolerability to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)


Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: 4 weeks ]
  2. Time to Cmax (Tmax) [ Time Frame: 4 weeks ]
  3. Area under the curve (AUC) [ Time Frame: 4 weeks ]
  4. Plasma half life (T1/2) [ Time Frame: 4 weeks ]
  5. Volume of distribution (V/F) [ Time Frame: 4 weeks ]
  6. Plasma Clearance (CL/F) [ Time Frame: 4 weeks ]
  7. Exploratory Surrogate Biomarker [ Time Frame: 2 weeks ]
    Explore potential surrogate biomarkers in peripheral blood mononuclear cells (PBMC).

  8. Preliminary tumor response [ Time Frame: Every 8 weeks up to end of treatment (EOT) ]
    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].



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged at least 19 years old.
  2. Patients histologically or cytologically diagnosed with advanced solid tumor.
  3. Patients for whom no standard therapies are available or who have failed in the existing conventional therapies.
  4. Patients with a measurable or evaluable lesion by the RECIST v1.1 [for patients with recurrent glioblastoma, the RANO guideline is applied].
  5. Patients with the Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
  6. Patients with the adequate function of bone marrow, kidney and liver as follows.

    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

  7. Patients with the life expectancy ≥ 12 weeks.
  8. 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)

  9. Patients who have voluntarily signed an informed consent to participate in this clinical study.

Exclusion Criteria:

  1. Patients with a history of hypersensitivity to the active ingredient or any component of the investigational product or biguanides.
  2. Patients with a current evidence of diabetes mellitus who are currently being treated with another biguanide (e.g., metformin)
  3. 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.)
  4. 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.
    • 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.
  5. Patients who have not been recovered from the toxicities to grade 1 of the therapy received prior to screening.
  6. Pregnant women or nursing mothers.
  7. Patients who were administered another investigational product within 3 weeks prior to screening.
  8. 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.
  9. Patients with suspected serious infectious diseases, intestinal paralysis, bowel obstruction, interstitial pneumonia, or pulmonary fibrosis.
  10. Patients with a history of psychiatric disorders likely to threaten the compliance with this protocol.
  11. Patients with a history of alcohol or drug abuse within 12 weeks prior to screening.
  12. Human Immunodeficiency Virus (HIV) infection or active hepatitis B or C. Patients with no detectable viral load could be enrolled.
  13. Patients with severe traumatism.
  14. 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.
  15. 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.
  16. Patients who are otherwise considered to be ineligible for this study on investigator's judgment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272256


Locations
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Korea, Republic of
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
Asan Medical Center
Seoul, Korea, Republic of
Yonsei University Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
ImmunoMet Therapeutics, Inc.
Investigators
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Principal Investigator: Sun Young Rha, MD, PhD Department of oncology
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Responsible Party: ImmunoMet Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03272256    
Other Study ID Numbers: IM_IM156-01
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases