A Phase I Study of SCC244

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

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

Study Overview

• Status: Unknown
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: Glumetinib for tablet

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: JIN LI, M.D; Phone Number: 22229 021-38804518; Email: lijin@csco.org.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai East Hospital
    • Principal Investigator: Jin Li, M.D.
    • Contact: Jin Li, M.D.; Phone Number: 22229 +86-021-38804518; Email: lijin@csco.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MTD(Max tolerance does)	To evaluate the MTD in patients with advanced solid tumor	35 days
DLT(Dose limit toxity)	To evaluate the DLT in patients with advanced solid tumor	35 days
BED(Biological effective dose)	To evaluate the BED in patients with advanced solid tumor	35 days
objective response rate (ORR)	To evaluate the ORR in patients with advanced solid tumor in Ib	8 weeks

Collaborators and Investigators

• Sponsor: Haihe Biopharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2017
• Primary Completion (Anticipated): July 30, 2021
• Study Completion (Anticipated): November 30, 2021

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): March 9, 2018
• Last Update Submitted That Met QC Criteria: March 8, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Safety, Tolerability, Pharmacokinetics, Anti-tumor Activity
• Other Study ID Numbers: SCC244-104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No