A Phase I Study of SCC244 in Patients with Advanced MET Alterations Solid Tumors

NCT03457532 | Completed Phase 1 DMC

• 1 other identifier: SCC244-104
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Solid Tumor

Keywords

Safety, Tolerability, Pharmacokinetics, Anti-tumor Activity

Outcome Measures

Primary Outcomes (4)

• DLT(Dose limit toxity)

  To evaluate the DLT in patients with advanced solid tumor

  35 days

• MTD(Max tolerance does)

  To evaluate the MTD 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

Study Arms (1)

Dose escalation study of Gumarontinib

EXPERIMENTAL

To determine the maximum tolerated dose (MTD) of Gumarontinib

Drug: Gumarontinib Tablets

Interventions

Gumarontinib Tablets DRUG

25mg; 50mg; 100mg; 200mg; 400mg; 600mg BID or QD(Decided by SMC accroding to the safty and PK data)

Also known as: SCC244

Dose escalation study of Gumarontinib

Eligibility Criteria

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

You may qualify if:

• Fully understand the study and signed the informed consent must be obtained prior to any screening procedures.
• Adults are more than 18 years old at the time of informed consent.
• Life expectancy is more than 12 weeks by the Investigator's discretion.
• For phase Ia study and cohort 1 in phase Ib study: Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors who failed the standard treatment or with no standard treatment available. For cohort 2 in phase Ib study: a) Patients with stage IIIb or IIIc NSCLC who are not candidates for definitive surgical resection or concurrent chemoradiation or patients with stage IV NSCLC (including PSC) confirmed histologically or cytologically. b) Patients who received is less than 2 lines of prior anti-tumor systemic therapy and had not previously used MET inhibitors. c) Participants with advanced/metastatic NSCLC must be unsuitable for chemotherapy or refused chemotherapy after fully informed or have failed one or two prior lines of systemic therapy
• Patients with MET alteration：1) MET amplification; 2) MET over-expression; 3）MET axon 14 skipping mutation or 4) MET fusion;
• At least 1 measurable target lesion according to RECIST 1.1;
• ECOG performance status of 0-1;
• Patients with HCC must be satisfied with liver function of Child Pugh Class A;
• Patients must have adequate organ function;
• International normalized ratio (INR) is less than 1.5 or activated partial thromboplastin time (aPTT) is less than 1.5 x ULN;
• Patients must have recovered from all toxicities related to prior anticancer therapies to grade is less than 1 (CTCAE v 4.03) with the exception of alopecia and grade 2 prior neuropathy;
• Patients who are willing and able to receive scheduled visits, treatment plan, laboratory tests and other required study procedures;
• Males and females of child-bearing potential must agree to use highly effective methods of contraception during dosing and for 6 months after stopping treatment. Males with pregnancy or nursing partner must adopt double barrier contraception to prevent sperm from affecting the fetus or child;
• Female patients can only participate in this study;
• Main Exlcusion:

Sponsors & Collaborators

• Haihe Biopharma Co., Ltd.: lead

Study Sites (1)

Shanghai East hospital

Shanghai, China

Location

Related Publications (1)

• Yu Y, Dong W, Shi Y, Wu R, Yu Q, Ye F, Zhou C, Dong X, Li X, Li Y, Li Z, Wu L, Pan Y, Shen H, Wu D, Xu Z, Wu J, Xu N, Qin Y, Zang A, Zhang J, Zhou J, Zhang X, Zhao Y, Li F, Wang H, Liu Q, Han Z, Li J, Lu S. A pooled analysis of clinical outcome in driver-gene negative non-small cell lung cancer patients with MET overexpression treated with gumarontinib. Ther Adv Med Oncol. 2024 Jul 31;16:17588359241264730. doi: 10.1177/17588359241264730. eCollection 2024.

  PMID: 39091606 DERIVED

MeSH Terms

Interventions

glumetinib

Study Officials

• Fugen Li

  Haihe Biopharma Co., Ltd.

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: March 7, 2018
• Study Start: December 16, 2017
• Primary Completion: September 22, 2023
• Study Completion: September 22, 2023
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

CN (1)