- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04200404
A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors
5. mai 2022 oppdatert av: CStone Pharmaceuticals
A Phase Ib/II, Multicenter Open-label Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors
This is a multicenter, open-label study of CS1001 in combination with regorafenib in participants with advanced or refractory cancers.
There will be a dose escalation portion in "allcomers"to find a suitable dose of regorafenib for combination use with CS1001.
This study will also enroll participants with specific tumor types in the phase II part of the study to assess the efficacy, pharmacokinetics and safety of the combined regimen (RP2D of regorafenib + CS 1001)
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
19
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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South Australia
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Kurralta Park, South Australia, Australia, 5037
- Ashford Cancer Centre Research
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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:
- All participants must have unresectable advanced or metastatic tumors that have histologic or cytologic documentation confirmed.
- Participant must have at least one measurable lesion by CT or MRI per RECIST 1.1; radiographic tumor assessment should be performed within 28 days prior to initiation of study treatment.
- ECOG performance status score of 0 or 1.
- Life expectancy ≥ 12 weeks.
- Fresh or archival tumor tissue must be provided for PD-L1 expression testing in selected cohorts.
- Adequate organ function
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result. Either Female or male participants must agree to use adequate contraceptive measures from signing informed consent and for 180 days after last investigational product administration, except for a participant with documented surgical sterilization or a postmenopausal female.
- Any toxic effects of prior anti-cancer therapy or surgical procedures resolved to baseline severity or NCI-CTCAE version 5 Grade 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).
- Subjects with hepatitis B virus (HBV) infection must have HBV DNA < 2000 IU/mL at screening, and requires continue anti-HBV treatment in the study
Exclusion Criteria:
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
- Participants with any condition that impairs their ability to take oral medication, such as lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
- Has known central nervous system (CNS) metastases and/or carcinomatous meningitis that is either symptomatic or untreated.
- Any prior (within 1 year) or current clinically significant ascites as measured by physical examination and that requires active paracentesis for control.
- Significant history of cardiac disease within 6 months prior to Day 1 of Cycle 1, myocardial infarction within the previous year, or current cardiac ventricular arrhythmias requiring medication, or left ventricular ejection fraction (LVEF) is below 50%.
- History or evidence of poorly controlled arterial hypertension.
- Any serious or uncontrolled medical disorder or active infection may increase the risk associated with study participation or dose.
- Administration of drugs known as strong CYP3A4 inducers or strong CYP3A4 inhibitors and the last dose was given in < 5 half-lives from the first investigational product administration.
- Any hemorrhage or bleeding event ≥ CTCAE Grade 3 within 28 days prior to the start of study treatment.
Other inclusion/exclusion criteria may apply.
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: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Phase Ib arm
arms 1. Phase Ib: advanced or refractory solid tumors;
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One course will last 28 days.
CS1001 will be intravenously administered every 4 weeks (Q4W).
One course will last 28 days.
Administration will be orally (p.o.) taken at different dose schemes.
Andre navn:
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Eksperimentell: Phase II arm
arms 2.Phase II: subjects with tumor of specific types
|
One course will last 28 days.
CS1001 will be intravenously administered every 4 weeks (Q4W).
One course will last 28 days.
Administration will be orally (p.o.) taken at different dose schemes.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Phase Ib (Safety Evaluation): Number of participants with adverse events
Tidsramme: Baseline up to 90 days post last dose, up to 2 years
|
Baseline up to 90 days post last dose, up to 2 years
|
Phase Ib (Safety Evaluation): Dose Limiting Toxicity (DLT)
Tidsramme: Baseline up to 90 days post last dose, up to 2 years
|
Baseline up to 90 days post last dose, up to 2 years
|
Phase II (Efficacy Expansion): Objective response rate (ORR)
Tidsramme: Up to 2 years
|
Up to 2 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Phase Ib (Safety Evaluation): Objective response rate (ORR)
Tidsramme: Up to 2 years
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Up to 2 years
|
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Disease control rate (DCR)
Tidsramme: Up to 2 years
|
Up to 2 years
|
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Progression Free Survival (PFS)
Tidsramme: Up to 2 years
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Up to 2 years
|
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Duration of Response (DoR)
Tidsramme: Up to 2 years
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Up to 2 years
|
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Overall Survival (OS)
Tidsramme: Up to 2 years
|
Up to 2 years
|
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Occurrence of anti-CS1001 antibody
Tidsramme: From first dose to 30 days after last dose, up to 2 years
|
From first dose to 30 days after last dose, up to 2 years
|
Phase II (Efficacy Expansion): : Number of participants with adverse events
Tidsramme: Baseline up to 90 days post last dose, up to 2 years
|
Baseline up to 90 days post last dose, up to 2 years
|
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Area under the plasma concentration-time curve (AUC)0-t of CS1001
Tidsramme: From first dose to 30 days after last dose, up to 2 years
|
From first dose to 30 days after last dose, up to 2 years
|
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Maximum plasma concentration (Cmax) of CS1001
Tidsramme: From first dose to 30 days after last dose, up to 2 years
|
From first dose to 30 days after last dose, up to 2 years
|
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Time to reach maximum plasma concentration (Tmax) of CS1001
Tidsramme: From first dose to 30 days after last dose, up to 2 years
|
From first dose to 30 days after last dose, up to 2 years
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Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Terminal elimination half-life (t1/2) of CS1001
Tidsramme: From first dose to 30 days after last dose, up to 2 years
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From first dose to 30 days after last dose, up to 2 years
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Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Clearance at Steady State (CLss) of CS1001
Tidsramme: From first dose to 30 days after last dose, up to 2 years
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From first dose to 30 days after last dose, up to 2 years
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Phase Ib (Safety Evaluation): Maximum plasma concentration (Cmax) of regorafenib
Tidsramme: From first dose to 30 days after last dose, up to 2 years
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From first dose to 30 days after last dose, up to 2 years
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Phase Ib (Safety Evaluation): Minimum plasma concentration (Cmin) of regorafenib
Tidsramme: From first dose to 30 days after last dose, up to 2 years
|
From first dose to 30 days after last dose, up to 2 years
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
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)
13. desember 2019
Primær fullføring (Faktiske)
13. mai 2021
Studiet fullført (Faktiske)
18. august 2021
Datoer for studieregistrering
Først innsendt
13. desember 2019
Først innsendt som oppfylte QC-kriteriene
13. desember 2019
Først lagt ut (Faktiske)
16. desember 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. mai 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. mai 2022
Sist bekreftet
1. mai 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CS1001/Regorafenib-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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