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A Phase I Study of SCC244

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03457532
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : March 9, 2018
Information provided by (Responsible Party):
Haihe Biopharma Co., Ltd.

Brief Summary:
This is a Phase 1a/1b multi-center and open label study to evaluate the safety, tolorability, pharmacokinetics and priliminary efficacy of SCC244 in advanced solid tumors patients with c-MET alteration

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: Glumetinib for tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Open-label, Dose Escalation and Dose Extension Phase 1 Study to Evaluate the Safety , Tolerability, Pharmacokinetics and Preliminary Efficacy of SCC244 in Advanced Solid Tumors Patients With c-MET Alteration
Actual Study Start Date : December 16, 2017
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : November 30, 2021

Arm Intervention/treatment
Experimental: Dose escalation study of Glumetinib
To determine the maximum tolerated dose (MTD) of Glumetinib
Drug: Glumetinib for tablet
25mg; 50mg; 100mg; 200mg; 400mg; 600mg BID or QD(Decided by SMC accroding to the safty and PK data)

Primary Outcome Measures :
  1. DLT(Dose limit toxity) [ Time Frame: 35 days ]
    To evaluate the DLT in patients with advanced solid tumor

  2. MTD(Max tolerance does) [ Time Frame: 35 days ]
    To evaluate the MTD in patients with advanced solid tumor

  3. BED(Biological effective dose) [ Time Frame: 35 days ]
    To evaluate the BED in patients with advanced solid tumor

  4. objective response rate (ORR) [ Time Frame: 8 weeks ]
    To evaluate the ORR in patients with advanced solid tumor in Ib

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Main Inclusion:

  1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
  2. Male and/or female subjects of non-childbearing potential between the ages of 18 and 70 years, inclusive.
  3. Life expectancy ≥ 12 weeks by the Investigator's judgment
  4. Locally advanced or metastatic solid tumor patients who have failed or relapsed on current standard of care for Phase 1a and advanced solid tumor patients who have failed or relapsed on current standard of care for Phase 1b.
  5. Patients with c-MET alteration:1) c-MET amplification; 2) c-MET over-expression or 3) c-MET axon 14 skipping.
  6. At least 1 measurable target lesion on the baseline scan as per RECIST 1.1
  7. Available qualified tissue sample (either fresh biopsy or archival tissue sample) is mandatory for phase Ib period, while fine needle aspiration and cytology samples are not sufficient for study eligibility screening.
  8. For phase Ia stage, ECOG performance score 0-1; For phase Ib stage, ECOG performance score 0-2
  9. Adequate organ function as documented
  10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures.
  11. International normalized ratio (INR) ≤ 1.5, or activated partial thromboplastin time (aPTT) ≤ 1.5 ULN

Main Exlcusion:

  1. Pregnant (serum human chorionic gonadotropin positive) or breastfeeding female patient.
  2. Prior received anti-tumor treatment, including anticancer drugs for the treatment within 28 days of first dose of study treatment or 5 half-lives of the agent, whichever is longer
  3. Prior received major surgery within 4 weeks of the first does.
  4. Palliative radiotherapy to bone metastasis within 4 weeks of the first does.
  5. Prior treated with another c-Met inhibitor
  6. Prior or concomitant other malignant tumor (except effectively controlled non-melanoma skin cancer, breast carcinoma in situ or cervix cancer in situ and superficial bladder cancer within past 5 years).
  7. Cardiac function impairment or clinically significant heart disease including congestive heart-failure ≥ Grade 2 according to grading of New York Heart Association, arrhythmia, conduction disorders requiring treatment, myocardium diseases, unstable angina or uncontrollable hypertension within 6 months prior to screening.
  8. QTcF-prolongation > 470 msec; or has risk factors for Torsades De Pointe, hypokalemia (serum potassium <3.0 mmol/L) or family history of long-QT-Syndrome
  9. History of stroke within 6 months prior to screening

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 identifier (NCT number): NCT03457532

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Contact: JIN LI, M.D 021-38804518 ext 22229

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Shanghai East hospital Recruiting
Shanghai, China
Contact: Jin Li, M.D.    +86-021-38804518 ext 22229   
Principal Investigator: Jin Li, M.D.         
Sponsors and Collaborators
Haihe Biopharma Co., Ltd.
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Responsible Party: Haihe Biopharma Co., Ltd. Identifier: NCT03457532    
Other Study ID Numbers: SCC244-104
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haihe Biopharma Co., Ltd.:
Safety, Tolerability, Pharmacokinetics, Anti-tumor Activity