Study of JAB-23E73 in Combination With Chemotherapy in Participants With Metastatic PDAC Harboring KRAS Gene Alterations
25 augusti 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
80
Fas
- Fas 2
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Jacobio Pharmaceuticals
- Telefonnummer: 86 10 56315466
- E-post: clinicaltrials@jacobiopharma.com
Studieorter
-
-
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Beijing, Kina
- Rekrytering
- Beijing Tsinghua Changgung Hospital
-
Kontakt:
- Beijing Tsinghua Changgung Hospital
- Telefonnummer: 86+13366152815
- E-post: joelbmu@126.com
-
Changsha, Kina
- Har inte rekryterat ännu
- Hunan Cancer Hospital
-
Kontakt:
- Hunan Cancer Hospital
- Telefonnummer: 86+18673181133
- E-post: liuzhenyang@hnca.org.cn
-
Harbin, Kina
- Har inte rekryterat ännu
- Harbin Medical University Cancer Hospital
-
Kontakt:
- Harbin Medical University Cancer Hospital
- Telefonnummer: 86+13845120210
- E-post: yanqiaozhang@126.com
-
Nanjing, Kina
- Har inte rekryterat ännu
- Jiangsu Province Hospital
-
Kontakt:
- Jiangsu Province Hospital
- Telefonnummer: 86+13585172066
- E-post: Xiaofengch198019@126.com
-
Shanghai, Kina
- Rekrytering
- Shanghai Jiaotong University School of Medicine Ruijin Hospital
-
Kontakt:
- Shanghai Jiaotong University School of Medicine Ruijin Hospita
- Telefonnummer: 86+13901943778 86+
- E-post: shenby@shsmu.edu.cn
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Taiyuan, Kina
- Rekrytering
- Shanxi Cancer Hospital
-
Kontakt:
- ShanXi Cancer Hospital
- Telefonnummer: 86+13811176181
- E-post: WXCAMS@126.com
-
Wuhan, Kina
- Rekrytering
- Zhongnan Hospital of Wuhan University
-
Kontakt:
- Zhongnan Hospital of Wuhan University
- Telefonnummer: 86-13971235235 86+13971235235
- E-post: pjxp888@126.com
-
Wuhan, Kina
- Rekrytering
- Wuhan Union Hospital of China
-
Kontakt:
- Wuhan Union Hospital Of China
- Telefonnummer: 86+13720117761
- E-post: heshuiwu@hust.ed.cn
-
Wuhan, Kina
- Har inte rekryterat ännu
- Hubei Province Hospital
-
Kontakt:
- Hubei Province Hospital
- Telefonnummer: 86+15629019627
- E-post: 971070316@qq.com
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Zhengzhou, Kina
- Har inte rekryterat ännu
- Henan Cancer Hospital
-
Kontakt:
- Henan Cancer Hospital
- Telefonnummer: 86+13937100233
- E-post: 2290773710@qq.com
-
Zhengzhou, Kina
- Har inte rekryterat ännu
- The First Affiliated Hospital of Zhengzhou University
-
Kontakt:
- 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
- Rekrytering
- Beijing Cancer Hospital
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Kontakt:
- 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 inte rekryterat ännu
- Zhejiang Cancer Hospital
-
Kontakt:
- Zhejiang Cancer Hospital
- Telefonnummer: 86+13858195803
- E-post: hzyingjieer@163.com
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Dose escalation/backfill
|
Orally, intravenous (IV) infusion
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Dose limiting toxicities (DLT)
Tidsram: Up to 28 days
|
The number and proportion of participants who experienced dose-limiting toxicities (DLT).
|
Up to 28 days
|
|
Adverse events.safety evaluation
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
ORR
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Up to approximately 3 years
|
maximum plasma concentration (Cmax)
|
Up to approximately 3 years
|
|
PK
Tidsram: Up to approximately 3 years
|
area under the plasma concentration-time curve (AUC)
|
Up to approximately 3 years
|
|
PK
Tidsram: Up to approximately 3 years
|
trough plasma concentration (Ctrough)
|
Up to approximately 3 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studierektor: Jacobio Pharmaceuticals, Jacobio Pharmaceuticals
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
16 juli 2026
Primärt slutförande (Beräknad)
31 december 2029
Avslutad studie (Beräknad)
31 december 2030
Studieregistreringsdatum
Först inskickad
4 juni 2026
Först inskickad som uppfyllde QC-kriterierna
8 juni 2026
Första postat (Faktisk)
10 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- JAB-23E73-2001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .