A Phase I Study of SCC244

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03457532
• Other study ID #: SCC244-104
• Status: Recruiting
• Phase: Phase 1
• First received: February 9, 2018
• Last updated: March 8, 2018
• Start date: December 16, 2017
• Est. completion date: November 30, 2021

Study information

• Verified date: February 2018
• Source: ShangHai HaiHe Pharmaceutical
• Contact: JIN LI, M.D
• Phone: 021-38804518
• Email: lijin[@]csco.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: November 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor

Intervention

Drug:
• Glumetinib for tablet
25mg; 50mg; 100mg; 200mg; 400mg; 600mg BID or QD(Decided by SMC accroding to the safty and PK data)

Locations

Country	Name	City	State
China	Shanghai East hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
ShangHai HaiHe Pharmaceutical

Country where clinical trial is conducted

China, 

Outcome

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