Study of JAB-23E73 in Combination With Chemotherapy in Participants With Metastatic PDAC Harboring KRAS Gene Alterations
25. august 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
80
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jacobio Pharmaceuticals
- Telefonnummer: 86 10 56315466
- E-post: clinicaltrials@jacobiopharma.com
Studiesteder
-
-
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Beijing, Kina
- Rekruttering
- Beijing Tsinghua Changgung Hospital
-
Ta kontakt med:
- Beijing Tsinghua Changgung Hospital
- Telefonnummer: 86+13366152815
- E-post: joelbmu@126.com
-
Changsha, Kina
- Har ikke rekruttert ennå
- Hunan Cancer Hospital
-
Ta kontakt med:
- Hunan Cancer Hospital
- Telefonnummer: 86+18673181133
- E-post: liuzhenyang@hnca.org.cn
-
Harbin, Kina
- Har ikke rekruttert ennå
- Harbin Medical University Cancer Hospital
-
Ta kontakt med:
- Harbin Medical University Cancer Hospital
- Telefonnummer: 86+13845120210
- E-post: yanqiaozhang@126.com
-
Nanjing, Kina
- Har ikke rekruttert ennå
- Jiangsu Province Hospital
-
Ta kontakt med:
- Jiangsu Province Hospital
- Telefonnummer: 86+13585172066
- E-post: Xiaofengch198019@126.com
-
Shanghai, Kina
- Rekruttering
- Shanghai Jiaotong University School of Medicine Ruijin Hospital
-
Ta kontakt med:
- Shanghai Jiaotong University School of Medicine Ruijin Hospita
- Telefonnummer: 86+13901943778 86+
- E-post: shenby@shsmu.edu.cn
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Taiyuan, Kina
- Rekruttering
- Shanxi Cancer Hospital
-
Ta kontakt med:
- ShanXi Cancer Hospital
- Telefonnummer: 86+13811176181
- E-post: WXCAMS@126.com
-
Wuhan, Kina
- Rekruttering
- Zhongnan Hospital of Wuhan University
-
Ta kontakt med:
- Zhongnan Hospital of Wuhan University
- Telefonnummer: 86-13971235235 86+13971235235
- E-post: pjxp888@126.com
-
Wuhan, Kina
- Rekruttering
- Wuhan Union Hospital of China
-
Ta kontakt med:
- Wuhan Union Hospital Of China
- Telefonnummer: 86+13720117761
- E-post: heshuiwu@hust.ed.cn
-
Wuhan, Kina
- Har ikke rekruttert ennå
- Hubei Province Hospital
-
Ta kontakt med:
- Hubei Province Hospital
- Telefonnummer: 86+15629019627
- E-post: 971070316@qq.com
-
Zhengzhou, Kina
- Har ikke rekruttert ennå
- Henan Cancer Hospital
-
Ta kontakt med:
- Henan Cancer Hospital
- Telefonnummer: 86+13937100233
- E-post: 2290773710@qq.com
-
Zhengzhou, Kina
- Har ikke rekruttert ennå
- The First Affiliated Hospital of Zhengzhou University
-
Ta kontakt med:
- The First Affiliated hospital of Zhengzhou University
- Telefonnummer: 86+13676932999
- E-post: yanruqin@163.com
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100142
- Rekruttering
- Beijing Cancer Hospital
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Ta kontakt med:
- Beijing Cancer Hospital
- Telefonnummer: 86+13911219511
- E-post: doctorshenlin@sina.com
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310005
- Har ikke rekruttert ennå
- Zhejiang Cancer Hospital
-
Ta kontakt med:
- Zhejiang Cancer Hospital
- Telefonnummer: 86+13858195803
- E-post: hzyingjieer@163.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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:
- Inability to swallow oral medications or the presence of gastrointestinal dysfunction or disease that may significantly alter drug absorption.
- 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.
- Prior treatment with KRAS G12C inhibitors, KRAS G12D inhibitors, pan-KRAS/pan RAS inhibitors, or other agents of the same class.
- Women who are pregnant or breast-feeding.
- Participants who have progressive disease or recurrence during neoadjuvant or adjuvant treatment, or within 6 months after the last dose of medication.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Dose escalation/backfill
|
Orally, intravenous (IV) infusion
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Jacobio Pharmaceuticals, Jacobio Pharmaceuticals
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
16. juli 2026
Primær fullføring (Antatt)
31. desember 2029
Studiet fullført (Antatt)
31. desember 2030
Datoer for studieregistrering
Først innsendt
4. juni 2026
Først innsendt som oppfylte QC-kriteriene
8. juni 2026
Først lagt ut (Faktiske)
10. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- JAB-23E73-2001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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