- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07589569
An Open-label, Multicenter, Phase II Clinical Study to Evaluate HRS-7058 in Patients With Pancreatic Cancer
25. maj 2026 opdateret af: Shandong Suncadia Medicine Co., Ltd.
An Open, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-7058 in Patients With Locally Advanced or Metastatic Pancreatic Cancer Harboring KRAS G12C Mutations Who Have Failed Prior Systemic Therapy.
This is a multicenter, open-label, single-arm, phase II cilinical trial designed to evaluate the efficacy and safety of the KRAS G12C selective inhibitor HRS-7058 in patients with KRAS G12C-mutated advanced pancreatic cancer who had failed 1-2 lines of previous systemic therapy.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
92
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Keke Yan
- Telefonnummer: +0518-81220121
- E-mail: keke.yan@hengrui.com
Undersøgelse Kontakt Backup
- Navn: Meng Qin
- Telefonnummer: +0518-81220121
- E-mail: meng.qin.mq8@hengrui.com
Studiesteder
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210003
- Rekruttering
- Jiangsu Province Hospital
-
Ledende efterforsker:
- Kuirong Jiang
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Kina, 300060
- Rekruttering
- Tianjin Medical University Cancer Institute & Hospital
-
Ledende efterforsker:
- Jihui Hao
-
-
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:
- Informed consent was obtained from all participants before participating in the study.
- Age from 18 to 75 years old (including both ends), regardless of gender;
- Patients with locally advanced unresectable, recurrent unresectable or metastatic pancreatic cancer, and adenocarcinoma confirmed by cytology or histological pathology;
- Participants had received at least one previous systemic therapy
- At least one measurable lesion according to RECIST v1.1;
- ECOG PS score 0 or 1;
- The expected survival time was more than 3 months.
- They were able to swallow medications and were able to adhere to trial and follow-up procedures.
- Adequate bone marrow and organ function within 7 days before the first dose (no use of blood components and/or cell growth factors within 14 days before starting study treatment;
- Women of childbearing potential had to agree to abstain from sexual intercourse (heterosexual intercourse) or to use a highly effective method of contraception from the time they provided informed consent until 30 days after the last dose of the trial drug. A blood test for human chorionic gonadotropin (HCG) had to be negative within 7 days before starting study treatment and she had to be nonlactating (if a serum pregnancy test was positive, pregnancy was ruled out and enrollment was confirmed after discussion with the sponsor). Men whose partner was a woman of childbearing potential had to agree to abstain from sex or to use a highly effective method of contraception from the time they provided written informed consent until 30 days after the last dose of the trial drug. Male patients also had to agree not to donate sperm during the same period
Exclusion Criteria:
- Presence of untreated or active central nervous system (CNS) metastases. Participants with a history of leptomeningeal metastasis or current leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis, and/or spinal cord compression.
- Subjects who had received general anesthesia
- Subjects with a history of myocardial infarction or unstable angina pectoris
- Subjects with atrioventricular block or cardiac insufficiency
- Subjects with a history of ischemic stroke or transient ischemic attack
- Subjects with poor blood pressure control after medication
- Subjects with abnormal clotting function
- Subjects with a history of mental illness and a history of cognitive impairment epilepsy
- Subjects with a history or possibility of a difficult airway
- Subject with a history of substance abuse and drug abuse
- Adrenoceptor agonists or antagonists were used before randomization
- Abnormal values in the laboratory
- Thyroid dysfunction
- Allergic to a drug ingredient or component
- Pregnant or nursing women
- No birth control during the specified period of time
- Participated in clinical trials of other drugs (received experimental drugs)
- The inestigators determined that other conditions were inappropriate for participation in this clinical trial
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: Treatment group A: HRS-7058
|
HRS-7058
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
ORR as assessed by IRC
Tidsramme: About 2 years
|
IRC evaluation
|
About 2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Investigator-assessed ORR
Tidsramme: About 2 years
|
Assessments BY INVESTIGATORS
|
About 2 years
|
|
IRC and investigator-assessed DoR
Tidsramme: About 2 years
|
IRC and investigator assessments
|
About 2 years
|
|
IRC and investigator-assessed DCR
Tidsramme: About 2 years
|
IRC and investigator assessments
|
About 2 years
|
|
IRC and investigator-assessed PFS
Tidsramme: About 2 years
|
IRC and investigator assessments
|
About 2 years
|
|
OS
Tidsramme: About 4 years
|
Assessments BY INVESTIGATORS
|
About 4 years
|
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 (Faktiske)
21. maj 2026
Primær færdiggørelse (Anslået)
1. december 2028
Studieafslutning (Anslået)
1. december 2028
Datoer for studieregistrering
Først indsendt
9. maj 2026
Først indsendt, der opfyldte QC-kriterier
9. maj 2026
Først opslået (Faktiske)
15. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HRS-7058-205
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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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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Shandong Suncadia Medicine Co., Ltd.RekrutteringAvanceret ondartet tumorKina
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Shandong Suncadia Medicine Co., Ltd.Rekruttering
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Shandong Suncadia Medicine Co., Ltd.Rekruttering
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Shandong Suncadia Medicine Co., Ltd.RekrutteringAvanceret uoperabel eller metastatisk brystkræftKina
-
Shandong Suncadia Medicine Co., Ltd.RekrutteringIkke-obstruktiv hypertrofisk kardiomyopatiKina
-
Shandong Suncadia Medicine Co., Ltd.Afsluttet
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Fudan UniversityIkke rekrutterer endnu
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Henan Cancer HospitalIkke rekrutterer endnu
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Shandong Suncadia Medicine Co., Ltd.Afsluttet