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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

Status

Rekruttering

Intervention / Behandling

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

Undersøgelse Kontakt Backup

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:

  1. Informed consent was obtained from all participants before participating in the study.
  2. Age from 18 to 75 years old (including both ends), regardless of gender;
  3. Patients with locally advanced unresectable, recurrent unresectable or metastatic pancreatic cancer, and adenocarcinoma confirmed by cytology or histological pathology;
  4. Participants had received at least one previous systemic therapy
  5. At least one measurable lesion according to RECIST v1.1;
  6. ECOG PS score 0 or 1;
  7. The expected survival time was more than 3 months.
  8. They were able to swallow medications and were able to adhere to trial and follow-up procedures.
  9. 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;
  10. 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:

  1. 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.
  2. Subjects who had received general anesthesia
  3. Subjects with a history of myocardial infarction or unstable angina pectoris
  4. Subjects with atrioventricular block or cardiac insufficiency
  5. Subjects with a history of ischemic stroke or transient ischemic attack
  6. Subjects with poor blood pressure control after medication
  7. Subjects with abnormal clotting function
  8. Subjects with a history of mental illness and a history of cognitive impairment epilepsy
  9. Subjects with a history or possibility of a difficult airway
  10. Subject with a history of substance abuse and drug abuse
  11. Adrenoceptor agonists or antagonists were used before randomization
  12. Abnormal values in the laboratory
  13. Thyroid dysfunction
  14. Allergic to a drug ingredient or component
  15. Pregnant or nursing women
  16. No birth control during the specified period of time
  17. Participated in clinical trials of other drugs (received experimental drugs)
  18. 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

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Kliniske forsøg med Kræft i bugspytkirtlen

Kliniske forsøg med HRS-7058

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