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Study to Evaluate the Safety and Anti-tumor Activity of SCC244

10. mars 2020 oppdatert av: Haihe Biopharma Co., Ltd.

A Phase I Trial to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of SCC244 in Subjects With Advanced Solid Tumors

This study evaluates the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of SCC244 in patients with advanced solid tumors with c-Met Alterations.

Studieoversikt

Status

Ukjent

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

113

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Yilong Wu, M.D.
  • Telefonnummer: +86-20-83827812*21187
  • E-post: syylwu@live.cn

Studiesteder

    • Guangzhou
      • Guangzhou, Guangzhou, Kina, 510080
        • Rekruttering
        • Guangdong General Hospital
        • Ta kontakt med:
          • Yilong Wu, MD
          • Telefonnummer: +86-20-83827812*21187
          • E-post: syylwu@live.cn

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Male or female subject ≥ 18 years of age.
  2. Life expectancy ≥ 12 weeks by the Investigator.
  3. In Phase Ia, histologically confirmed NSCLC (including sarcomatoid carcinoma) with c-Met alterations defined as c-Met gene amplification ≥ 5 copies or c-Met protein overexpression (IHC 3+) or c-Met exon 14 skipping mutation. No EGFR T790M mutation for subjects with c-Met gene amplification or c-Met protein overexpression; KRAS/ALK/ROS1 WT or unknown mutation/rearrangement status for subjects with c-Met exon 14 skipping mutation.
  4. In Phase Ib, histologically confirmed NSCLC as in Phase Ia, AGC, or HCC with c-Met gene amplification ≥ 5 copies, or c-Met protein overexpression (IHC 3+). HCC subjects must have Child Pugh Class A.
  5. Available fresh samples of NSCLC (except for c-Met exon 14 skipping mutation that can be from archival tumor sample), and available fresh or archival tumor sample of AGC and HCC for c-Met gene alteration characterization or determination of c-Met protein overexpression (IHC 3+). Fine needle aspiration and cytology samples are not sufficient.
  6. In Phase Ia/Ib, all NSCLC subjects with EGFR mutation must have progressive disease after 1 or 2 lines of prior therapy including at least an EGFR-TKI targeting other than c-Met alterations. Subjects with c-Met exon 14 skipping mutation must have received at least 1 line of standard therapy in Phase Ia and can be first or second line subjects in Phase Ib. In Phase Ib, subjects with AGC must have progressive disease after at least 1 line of prior standard therapy and subjects with HCC must have received 1 line of targeted agent therapy.
  7. At least 1 measurable target lesion.
  8. Eastern Cooperative Oncology Group (ECOG) performance score 0-2.
  9. Adequate organ function as documented
  10. Toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade 0 or 1 as per the National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE), excluding alopecia.

Exclusion Criteria:

  1. Pregnant (serum human chorionic gonadotropin positive) or breastfeeding female subject.
  2. Prior anti-tumor systemic chemotherapy or loco-regional therapy for HCC (such as percutaneous ethanol injection, chemoembolization or radiofrequency ablation), biologics therapy, Chinese herbal anti-cancer or anti-infective medication within 28 days or 5 × half life time, whichever occurs last, before the first dose.
  3. Prior therapy with another c-Met inhibitor.
  4. Presence of EGFR T790M mutation in NSCLC subjects pretreated with an EGFR-TKI; Known KRAS/ALK/ROS1 mutation/rearrangement in NSCLC subjects with c-Met exon 14 skipping mutation.
  5. Known or suspected hypersensitivity to SCC244 and/or its excipients.
  6. Palliative radiotherapy to bone metastasis within 4 weeks prior to the first dosing.
  7. 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).
  8. Cardiac function impairment or clinically significant heart disease including congestive heart-failure ≥ Grade 2 according to grading of New York Heart Association, arrhythmia, conduction abnormality requiring treatment, myocardium diseases or uncontrollable hypertension within 6 months prior to screening. QTc-prolongation > 470 msec, risk factors for Torsades De Pointe, hypokalemia or family history of long-QT-Syndrome.
  9. History of stroke within 6 months prior to screening.
  10. Known central nervous system or brain metastasis that is either symptomatic or untreated. Metastases that have been treated by complete resection and/or radiotherapy demonstrating stability or improvement are not an exclusion criterion provided they are stable as shown by CT scan for at least 1 month without evidence of cerebral edema and no requirements for corticosteroids or anticonvulsants.
  11. Inability to swallow oral medication, or active digestive system disease, or major digestive surgery, which in the Investigator's opinion can affect administration and absorption of SCC244 (such as active ulcerative disease, uncontrollable diarrhea, and small bowel resection).
  12. Any disease or condition with clinical significance (such as pancreatitis, uncontrollable diabetes, active or uncontrollable infection, drug or alcohol abuse, or psychiatric conditions), which can affect protocol compliance.
  13. Positive result for active infection by hepatitis B or C virus (HBV or HCV); known positivity for human immunodeficiency virus (HIV) infection.
  14. Men and women of reproductive potential not willing or not able to employ a highly effective method of birth control/contraception to prevent pregnancy until the end of trial.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Doseeskaleringsstudie av Glumetinib
For å bestemme maksimal tolerert dose (MTD) av Glumetinib
Either at 100mgSD、100mgQD、200mgSD、200mgQD、400mgSD、400mgQD、300mgBID、400mgBID

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
MTD (maks toleranse gjør)
Tidsramme: 35 dager
For å evaluere MTD hos pasienter med avansert solid tumor
35 dager
DLT (dosegrense toksisitet)
Tidsramme: 35 dager
For å evaluere DLT hos pasienter med avansert solid tumor
35 dager
BED (Biologisk effektiv dose)
Tidsramme: 35 dager
For å evaluere BED hos pasienter med avansert solid tumor
35 dager
ORR(Objective response rate)
Tidsramme: 8 weeks
To evaluate the ORR in patients with advanced solid tumor in Ib
8 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Yilong Wu, M.D., Guangdong Provincial People's Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. september 2017

Primær fullføring (Forventet)

1. oktober 2021

Studiet fullført (Forventet)

1. oktober 2021

Datoer for studieregistrering

Først innsendt

7. august 2017

Først innsendt som oppfylte QC-kriteriene

8. mars 2018

Først lagt ut (Faktiske)

15. mars 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. mars 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. mars 2020

Sist bekreftet

1. september 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SCC244-101

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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