- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07624864
A Study to Evaluate the Safety, Tolerability, PK and Efficacy of Hemay5087 in Patients With Advanced Solid Tumors
29. maj 2026 opdateret af: Ganzhou Hemay Pharmaceutical Co., Ltd
A PHASE I CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETIC CHARACTERISTICS, AND PRELIMINARY ANTI-TUMOR EFFICACY OF HEMAY5087 IN PATIENTS WITH ADVANCED SOLID TUMORS
An open-label phase I clinical study,which enrolled subjects with advanced solid tumors who have failed to respond to adequate standard therapies or have no available effective standard therapy.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
24
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: jingyi xu
- Telefonnummer: 86-022-24899621
- E-mail: xujingyi@hemay.com.cn
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Subjects who voluntarily signed a written informed consent form before the start of the study;
- Subjects who have pathologically (histologically or cytologically) confirmed advanced solid tumorsand have failed to respond to adequate standard therapies or currently have no available effective standard therapy .
- Subjects who have a least one measurable lesion that can be evaluated by CT/MRI and meets the requirement for reproducible evaluation in RECIST V1.1;
- At least 4 weeks or 5 half-lives (whichever is shorter) have elapsed since the most recent treatment (chemotherapy, targeted therapy, immunotherapy, radiotherapy, and/or major surgery, etc.), and the participant has recovered from toxicities caused by prior treatment to grade ≤ 1 (Common Terminology Criteria for Adverse Events [CTCAE] v6.0) [except for alopecia, pigmentation, peripheral sensory neuropathy, hypothyroidism, and other toxicities judged by the investigator to pose no safety risk];
- Subjects with ECOG PS score of 0-1;
- Subjects with expected survival more than 3 months;
- Participants (including their partners) have no plan for pregnancy from signing the informed consent form through 6 months after the last dose and voluntarily agree to use effective contraception;
Exclusion Criteria:
- Women during pregnancy or breastfeeding;
- Positive syphilis testing; positive hepatitis C virus (HCV) antibody with HCV-RNA > ULN;;
- Have received investigational drug treatment in other clinical oncology therapeutic trials within 4 weeks prior to enrollment;
- Aallergy to the active ingredient or excipients of the investigational medicinal product;
- Patients with a history of alcohol or drug abuse or dependence, or a history of severe mental illness;
- The investigator considers the subject to be unsuitable for participation in this clinical trial due to any clinical or laboratory abnormalities.
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 |
|---|---|
|
Eksperimentel: Eksperimentel gruppe
Intravenøs infusion, En gang per behandlingscyklus
|
intravenous infusion,once every 3 weeks
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Antal deltagere med uønskede hændelser
Tidsramme: 3 ugers behandling
|
3 ugers behandling
|
|
Forekomst af dosisbegrænsende toksicitet (DLT) i hver dosisgruppe
Tidsramme: 3 ugers behandling
|
3 ugers behandling
|
|
Maksimal tolereret dosis (MTD) eller Maksimal klatringsdosis (MAD) af Hemay181
Tidsramme: 3 ugers behandling
|
3 ugers behandling
|
|
Efterfølgende anbefalede doser af Hemay181
Tidsramme: 3 ugers behandling
|
3 ugers behandling
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Objektiv svarprocent
Tidsramme: 3 ugers behandling
|
3 ugers behandling
|
|
|
Varighed af svar
Tidsramme: 3 ugers behandling
|
3 ugers behandling
|
|
|
Hyppighed for sygdomsbekæmpelse
Tidsramme: 3 ugers behandling
|
3 ugers behandling
|
|
|
Tid til at svare
Tidsramme: 3 ugers behandling
|
3 ugers behandling
|
|
|
Progressionsfri overlevelse
Tidsramme: 3 ugers behandling
|
3 ugers behandling
|
|
|
Maximum Plasma Concentration (Cmax)
Tidsramme: 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
Pharmacokinetic (PK) profile
|
0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
|
Time to reach maximum concentration (Tmax)
Tidsramme: 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
Pharmacokinetic (PK) profile
|
0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
|
Elimination half life(t1/2)
Tidsramme: 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
Pharmacokinetic (PK) profile
|
0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
|
Plasma Clearance(CL)
Tidsramme: 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
Pharmacokinetic (PK) profile
|
0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
|
Mean Residence Time from 0 to last time of quantifiable concentration(MRT 0-t)
Tidsramme: 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
Pharmacokinetic (PK) profile
|
0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
|
Mean Residence Time from 0 to infinite time(MRT 0-∞)
Tidsramme: 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
Pharmacokinetic (PK) profile
|
0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
|
Area under the plasma concentration-time curve from 0 to last time of quantifiable concentration(AUC 0-t)
Tidsramme: 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
Pharmacokinetic (PK) profile
|
0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
|
Area under the plasma concentration-time curve from 0 extrapolated to infinite time(AUC 0-∞)
Tidsramme: 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
Pharmacokinetic (PK) profile
|
0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
|
Percentage of the residual area (AUC%Extra)
Tidsramme: 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
Pharmacokinetic (PK) profile
|
0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
|
Volume of distribution(Vz)
Tidsramme: 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
Pharmacokinetic (PK) profile
|
0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
|
Elimination rate constant(λz)
Tidsramme: 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
Pharmacokinetic (PK) profile
|
0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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 (Anslået)
15. juli 2026
Primær færdiggørelse (Anslået)
30. april 2028
Studieafslutning (Anslået)
30. juni 2028
Datoer for studieregistrering
Først indsendt
22. maj 2026
Først indsendt, der opfyldte QC-kriterier
29. maj 2026
Først opslået (Faktiske)
3. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- HM5087ST1S01
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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