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Study of JAB-23E73 in Combination With Chemotherapy in Participants With Metastatic PDAC Harboring KRAS Gene Alterations

8. juni 2026 opdateret af: Jacobio Pharmaceuticals Co., Ltd.

A Multicenter, Phase Ib/III Study to Evaluate JAB-23E73 in Combination With Nab-Paclitaxel and Gemcitabine in Participants With Metastatic Pancreatic Ductal Adenocarcinoma Harboring KRAS Gene Alterations

The purpose of this study is to determine the safety and efficacy of pan KRAS inhibitor JAB-23E73 in combination with nab-paclitaxel and gemcitabine in participants with metastatic PDAC harboring KRAS gene alterations.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a phase Ib/III, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antineoplastic activity of pan-KRAS inhibitor JAB-23E73 in combination with nab-paclitaxel and gemcitabine in treatment-naive participants with metastatic PDAC.

Phase Ib study：an open-label study, including dose escalation and backfill cohorts, with approximately 40-80 participants planned to be enrolled (including approximately 20-50 participants in the backfill cohort),Aiming to determine the recommended phase III dose [RP3D] within investigated patient population groups.

Phase III: Following confirmation of the efficacy and safety of JAB-23E73 in combination with the AG regimen in Phase Ib, a Phase III trial will be initiated to evaluate the efficacy and safety of JAB-23E73 plus AG versus AG alone for the treatment of metastatic PDAC.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
      • Beijing, Kina
        • Beijing Tsinghua Changgung Hospital
        • Kontakt:
          • Beijing Tsinghua Changgung Hospital
          • Telefonnummer: 86+13366152815
          • E-mail: joelbmu@126.com
      • Changsha, Kina
        • Hunan Cancer Hospital
        • Kontakt:
      • Harbin, Kina
        • Harbin Medical University Cancer Hospital
        • Kontakt:
          • Harbin Medical University Cancer Hospital
          • Telefonnummer: 86+13845120210
          • E-mail: yanqiaozhang@126.com
      • Nanjing, Kina
        • Jiangsu Province Hospital
        • Kontakt:
      • Shanghai, Kina
        • Shanghai Jiaotong University School of Medicine Ruijin Hospital
        • Kontakt:
          • Shanghai Jiaotong University School of Medicine Ruijin Hospita
          • Telefonnummer: 86+13901943778 86+
          • E-mail: shenby@shsmu.edu.cn
      • Taiyuan, Kina
        • Shanxi Cancer Hospital
        • Kontakt:
          • ShanXi Cancer Hospital
          • Telefonnummer: 86+13811176181
          • E-mail: WXCAMS@126.com
      • Wuhan, Kina
        • Wuhan Union Hospital Of China
        • Kontakt:
      • Wuhan, Kina
        • Zhongnan Hospital of Wuhan University
        • Kontakt:
          • Zhongnan Hospital of Wuhan University
          • Telefonnummer: 86-13971235235 86+13971235235
          • E-mail: pjxp888@126.com
      • Wuhan, Kina
        • Hubei Province Hospital
        • Kontakt:
          • Hubei Province Hospital
          • Telefonnummer: 86+15629019627
          • E-mail: 971070316@qq.com
      • Zhengzhou, Kina
        • Henan Cancer Hospital
        • Kontakt:
      • Zhengzhou, Kina
        • The First Affiliated Hospital of Zhengzhou University
        • Kontakt:
          • The First Affiliated hospital of Zhengzhou University
          • Telefonnummer: 86+13676932999
          • E-mail: yanruqin@163.com
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100142
        • Beijing Cancer Hospital
        • Kontakt:
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310005
        • Zhejiang Cancer Hospital
        • Kontakt:

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.Written informed consent signed by the participant or the participant's legally authorized representative must be obtained prior to performing any study-related procedures. 2. Histologically or cytologically confirmed metastatic PDAC.

3. No prior systemic antitumor therapy for advanced disease (treatment-naïve). 4. Presence of KRAS gene alterations: be enrolled upon approval by the sponsor).

5. ECOG performance status score of 0 or 1. 6. Adequate organ function.

Exclusion Criteria:

  1. Inability to swallow oral medications or the presence of gastrointestinal dysfunction or disease that may significantly alter drug absorption.
  2. A history of another malignancy within 2 years prior to the first dose, histologically distinct from the cancer under study, except for carcinoma in situ of the cervix, superficial non-invasive bladder cancer, or adequately treated stage I non-melanoma skin cancer.
  3. Prior treatment with KRAS G12C inhibitors, KRAS G12D inhibitors, pan-KRAS inhibitors, or other agents of the same class.
  4. Primary central nervous system (CNS) tumors.
  5. Women who are pregnant or breast-feeding.
  6. Participants who have progressive disease or recurrence during neoadjuvant or adjuvant treatment, or within 6 months after the last dose of medication.

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: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dose escalation/backfill
Medicin: JAB-23E73 tablet，nab-paclitaxel，gemcitabine
Orally, intravenous (IV) infusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dose limiting toxicities (DLT)
Tidsramme: Up to 28 days
The number and proportion of participants who experienced dose-limiting toxicities (DLT).
Up to 28 days
Adverse events.safety evaluation
Tidsramme: Up to approximately 3 years
The types, incidence, severity, and outcomes of adverse events and serious adverse events evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Up to approximately 3 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ORR
Tidsramme: Up to approximately 3 years
Objective response rate, ORR is defined as the proportion of participants with confirmed complete response or partial response
Up to approximately 3 years
DOR
Tidsramme: Up to approximately 3 years
Duration of response, DOR is defined as the time from the first documented CR or PR to the first occurrence of disease progression or death from any cause, whichever occurs first
Up to approximately 3 years
TTR
Tidsramme: Up to approximately 3 years
Time to Response, TTR is defined as the time from the first dose of study treatment to the first documented CR or PR.
Up to approximately 3 years
PFS
Tidsramme: Up to approximately 3 years
Progression-Free Survival , PFS is defined as the time from the first dose of study treatment to the first documented disease progression or death from any cause, whichever occurs first.
Up to approximately 3 years
DCR
Tidsramme: Up to approximately 3 years
Disease Control Rate, DCR is defined as the proportion of participants whose best overall response is CR, PR, or SD..
Up to approximately 3 years
OS
Tidsramme: Up to approximately 3 years
Overall Survival , OS is defined as the time from the first dose of study treatment to death from any cause.
Up to approximately 3 years
PK
Tidsramme: Up to approximately 3 years
maximum plasma concentration (Cmax)
Up to approximately 3 years
PK
Tidsramme: Up to approximately 3 years
area under the plasma concentration-time curve (AUC)
Up to approximately 3 years
PK
Tidsramme: Up to approximately 3 years
trough plasma concentration (Ctrough)
Up to approximately 3 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Jacobio Pharmaceuticals Co., Ltd.

Efterforskere

  • Studieleder: Jacobio Pharmaceuticals, Jacobio Pharmaceuticals

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)

22. juni 2026

Primær færdiggørelse (Anslået)

31. december 2029

Studieafslutning (Anslået)

31. december 2030

Datoer for studieregistrering

Først indsendt

4. juni 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • JAB-23E73-2001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Ingen

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