CompletedPhase 1

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

China177 participantsStarted 2017-12-16

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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;

What they're measuring

DLT(Dose limit toxity)

Timeframe: 35 days

MTD(Max tolerance does)

Timeframe: 35 days

BED(Biological effective dose)

Timeframe: 35 days

objective response rate (ORR)

Timeframe: 8 weeks

Trial details

NCT IDNCT03457532

SponsorHaihe Biopharma Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-22

View on ClinicalTrials.gov More Advanced Solid Tumor trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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;