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

NCT03272256 | Completed Phase 1 DMC

• 1 other identifier: IM_IM156-01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicity (DLT)

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

  4 weeks

Secondary Outcomes (8)

• Maximum plasma concentration (Cmax)

  4 weeks

• Time to Cmax (Tmax)

  4 weeks

• Area under the curve (AUC)

  4 weeks

• Plasma half life (T1/2)

  4 weeks

• Volume of distribution (V/F)

  4 weeks

Study Arms (1)

IM156, Dose escalation

EXPERIMENTAL

Drug: IM156

Interventions

IM156 DRUG

Sequential 3+3 design.

IM156, Dose escalation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ImmunoMet Therapeutics, Inc.: lead

Study Sites (3)

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Yonsei University Severance Hospital

Seoul, South Korea

Location

Study Officials

• Sun Young Rha, MD, PhD

  Department of oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 5, 2017
• Study Start: October 9, 2017
• Primary Completion: December 2, 2019
• Study Completion: July 28, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

KR (3)