- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04941339
A Study of MRG002 in the Treatment of Patients With HER2-positive Advanced Solid Tumors
2. december 2021 opdateret af: Shanghai Miracogen Inc.
A Phase I, Open-label, Multi-center, First in Human, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of MRG002 in Patients With HER2 Positive Advanced Solid Tumors
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-positive advanced solid tumors.
Studieoversigt
Detaljeret beskrivelse
This study consists of two parts.
Phase Ia is a dose escalation study to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of MRG002.
Phase Ib is a dose expansion study to further assess the efficacy and safety of MRG002 at confirmed RP2D.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
74
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Shanghai
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Shanghai, Shanghai, Kina, 200120
- Rekruttering
- Shanghai Oriental Hospital
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Kontakt:
- Jin Li, Doctor
- Telefonnummer: 86-21-38804518
- E-mail: lijin@csco.org.cn
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Understands and provides written informed consent and willing to follow the requirements specified in protocol;
- Both genders;
- Aged 18 to 75 (including 18 and 75);
- Expected survival time ≥ 12 weeks;
- Patients with histologically and/or cytologically confirmed HER2-positive solid tumors who have failed standard therapy or for whom no standard therapy exists or for whom standard therapy is not appropriate at current stage;
- Patients must have at least one evaluable lesion (Phase Ia) or measurable lesion (Phase Ib) according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);
- The score of ECOG for performance status is 0 or 1;
- Prior anti-tumor treatment-related AEs (NCI CTCAE v5.0 Criteria) have recovered to ≤ Grade 1 (except alopecia);
- No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%;
- Organ functions must meet the basic requirements;
- Coagulation function must meet the basic requirements;
- Cumulative anthracycline dose ≤ 360 mg/m2 doxorubicin or its equivalent, 720 mg/m2 epirubicin.
Exclusion Criteria:
- Received radiotherapy, chemotherapy, biotherapy, immunotherapy, or other anti-tumor drugs within 3 weeks prior to the first dose of MRG002 treatment;
- History of severe cardiac disease;
- Clinically significant abnormalities in rhythm, conduction, and resting ECG morphology;
- Patients with poorly controlled hypertension or clinically significant vascular disease;
- History of moderate to severe dyspnea at rest due to advanced cancer or their complications, severe primary lung disease, or current need of continuous oxygen therapy, or any history of interstitial lung disease (ILD) or pneumonitis;
- Nausea and vomiting of any kind difficult to control, or chronic gastrointestinal disease;
- Patients with symptoms of central nervous system or brain metastasis or received treatment for central nervous system or brain metastasis within 3 months prior to the first dose of MRG002 treatment;
- Major surgery not fully recovery within 4 months prior to the first dose of MRG002 treatment;
- History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab injection;
- Evidence of active infection of hepatitis B or hepatitis C;
- History of immunodeficiency, including human immunodeficiency virus (HIV) infection, or other immunodeficiency disease, or history of organ transplantation;
- Any serious and/or uncontrolled disease or other condition that, considered by the investigator and sponsor, may compromise the patient's participation in this study;
- Received systemic corticosteroids within 4 weeks prior to the first dose of MRG002 treatment;
- Female patients with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment.
- Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: MRG002
All patients in Phase Ia (dose escalation) and Phase Ib (dose expansion) will be administrated MRG002 on Day 1 of every 3 weeks (21-day cycle).
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Administreres intravenøst
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Maximum Tolerated Dose (MTD)
Tidsramme: DLT will be evaluated during the first treatment cycle (Day 1-28)
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The highest dose confirmed wherein ≤ 1/6 of patients in a treatment cohort experiences a dose-limiting toxicity (DLT).
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DLT will be evaluated during the first treatment cycle (Day 1-28)
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Recommended Phase II Dose (RP2D)
Tidsramme: Baseline to study completion (up to 6 months)
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The dose level of MRG002 recommended for further clinical studies based on assessment of the safety, efficacy and PK data from this study.
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Baseline to study completion (up to 6 months)
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Adverse Events (AEs)
Tidsramme: Baseline to 49 days after the last dose of study treatment
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Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.
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Baseline to 49 days after the last dose of study treatment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Objective Response Rate (ORR)
Tidsramme: Baseline to study completion (up to 6 months)
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ORR is defined as the proportion of subjects with CR and PR assessed by IRC and investigator according to RECIST v1.1.
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Baseline to study completion (up to 6 months)
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Duration of Response (DoR)
Tidsramme: Baseline to study completion (up to 6 months)
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DoR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.
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Baseline to study completion (up to 6 months)
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Progression Free Survival (PFS)
Tidsramme: Baseline to study completion (up to 6 months)
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PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
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Baseline to study completion (up to 6 months)
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Pharmacokinetics (PK) parameter of MRG002: Cmax
Tidsramme: Baseline to 21 days after the last dose of study treatment
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Maximum observed plasma concentration.
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Baseline to 21 days after the last dose of study treatment
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Pharmacokinetics (PK) parameter of MRG002: Tmax
Tidsramme: Baseline to 21 days after the last dose of study treatment
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Time to reach maximum plasma concentration.
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Baseline to 21 days after the last dose of study treatment
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Pharmacokinetics (PK) parameter of MRG002: t1/2
Tidsramme: Baseline to 21 days after the last dose of study treatment
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The time required for plasma concentration to decreased by on half.
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Baseline to 21 days after the last dose of study treatment
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Pharmacokinetics (PK) parameter of MRG002: AUClast
Tidsramme: Baseline to 21 days after the last dose of study treatment
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Area under the curve up to the last validated measurable plasma concentration.
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Baseline to 21 days after the last dose of study treatment
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Immunogenicity
Tidsramme: Baseline to 21 days after the last dose of study treatment
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The proportion of patients with positive ADA immunogenicity results.
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Baseline to 21 days after the last dose of study treatment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jin Li, Doctor, Shanghai Oriental Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
21. november 2018
Primær færdiggørelse (Forventet)
1. oktober 2022
Studieafslutning (Forventet)
1. oktober 2022
Datoer for studieregistrering
Først indsendt
20. juni 2021
Først indsendt, der opfyldte QC-kriterier
20. juni 2021
Først opslået (Faktiske)
28. juni 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. december 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. december 2021
Sidst verificeret
1. december 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MRG002-001
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Kliniske forsøg med MRG002
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Shanghai Miracogen Inc.RekrutteringLokalt avanceret mavekræft | Metastatisk HER2 Positiv Gastroøsofageal Junction CancerKina
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Shanghai Miracogen Inc.RekrutteringAvanceret eller metastatisk galdevejskræftKina
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Shanghai Miracogen Inc.Ikke rekrutterer endnuIkke-småcellet lungekræft (NSCLC)Kina
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Shanghai Miracogen Inc.RekrutteringMetastatisk Urothelial Carcinom | Lokalt avanceret Urothelial CancerKina
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Shanghai Miracogen Inc.RekrutteringAvanceret eller metastatisk brystkræftKina
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Shanghai Miracogen Inc.RekrutteringAvancerede solide tumorer | Avanceret eller metastatisk mavekræft | Avanceret eller metastatisk Gastroøsofageal Junction CancerForenede Stater
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Shanghai Miracogen Inc.RekrutteringBrystkræft med levermetastaserKina
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Shanghai Miracogen Inc.RekrutteringAvancerede maligne solide tumorerKina
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Shanghai Miracogen Inc.RekrutteringAvanceret brystkræft | Metastatisk brystkræftKina
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Shanghai Miracogen Inc.RekrutteringAvanceret eller metastatisk Urothelium CancerKina