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Clinical Trial of DN022150 Combined With AG Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12D Mutation

15. juni 2026 opdateret af: Jiangxi Kvvit Pharmaceutical Co., Ltd.
This study investigates the first-line treatment of advanced pancreatic cancer with KRAS G12D mutation.The study consists of two stages I, Stage I ：explores the combination dose and the second phase; Stage II ：patients were randomized 1:1 to receive either the experimental regimen DN022150 plus AG or the control regimen AG alone.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

465

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

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

Studiekontakt

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. Voluntarily signed informed consent form
  2. Age 18-75 years (inclusive), male or female, at the time of signing informed consent
  3. Life expectancy ≥ 12 weeks
  4. Subjects with confirmed KRAS G12D who have not received prior systemic antineoplastic therapy for advanced or metastatic pancreatic cancer
  5. ECOG score of performance status 0 ~ 1
  6. At least one measurable lesion by RECIST v1.1 criteria
  7. Adequate organ function
  8. Effective methods of contraception during the study

Exclusion Criteria:

  1. Progression or other malignancy requiring treatment within 5 years prior to enrollment
  2. Prior targeted therapy for KRAS G12D
  3. With central nervous system metastasis
  4. Uncontrolled fluid accumulation
  5. Other anticancer therapy within 4 or 5 half-lives (whichever is shorter) before treatment
  6. Concomitant clinically significant cardiovascular disease
  7. Concurrent major acute or chronic infectious disease
  8. 4. Subjects who have undergone other major surgery other than diagnostic or biopsy, or are expected to undergo major surgery during the study;
  9. History of severe mental or psychological illness or drug abuse or a history of severe alcohol abuse
  10. Other situations not suitable for the study judged by the investigator

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: DN022150+AG( Stage I ）
Stage I，To evaluate the safety and tolerability of two different doses of DN022150 for Injection combined with AG regimen preset, and to determine the recommended dose of DN022150 for Injection combined with AG regimen for efficacy expansion based on the PK and preliminary efficacy data. After the completion of efficacy expansion, the safety, tolerability, PK and preliminary efficacy data of the first phase will be synthesized to confirm the RP3D of DN022150 combined with AG regimen
Medicin: DN022150+AG( Stage I ）
28-day /cycle
Andre navne:
  • Dose-finding group
Eksperimentel: DN022150+AG（ Stage II）
Stage II DN022150（ RP3D)+AG
Medicin: DN022150+AG（Stage II）
28-day /cycle
Andre navne:
  • Testgruppe
Placebo komparator: DN022150 placebo+AG（ Stage II）
Stage II DN022150 placebo+AG
Medicin: placebo+AG（Stage II）
28-day /cycle
Andre navne:
  • Kontrolgruppe

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
DLT
Tidsramme: up to 2 years
stage I ：To evaluate the safety and tolerability of different doses of DN022150 for Injection combined with AG regimen in participants with locally advanced or metastatic pancreatic cancer, including the incidence of dose limiting toxicity (DLT), explore the MTD, and determine the RP3D of DN022150 for Injection combined with AG regimen in combination with PK and efficacy data
up to 2 years
PFS as assessed by BICR per RECIST 1.1
Tidsramme: up to 2 years
stage II
up to 2 years
OS
Tidsramme: up to 2 years
stage II
up to 2 years
ORR
Tidsramme: up to 2 years
stage I
up to 2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence and severity of adverse events (AEs) graded by NCI-CTCAE v6.0
Tidsramme: up to 2 years
stage I&II
up to 2 years
DOR as assessed by the investigator per RECIST v1.1
Tidsramme: up to 2 years
stage I
up to 2 years
Cmin, ss
Tidsramme: up to 2 year
stage I&II: Steady State Trough Concentration
up to 2 year
Pancreatic cancer quality of life specific scale
Tidsramme: up to 2 years
stage II
up to 2 years
DCR as assessed by the investigator per RECIST v1.1
Tidsramme: up to 2 years
stage I
up to 2 years
PFS assessed by the investigator per RECIST v1.1
Tidsramme: up to 2 years
stage I
up to 2 years
OS
Tidsramme: up to 2 years
stage I
up to 2 years
PFS as assessed by the investigator per RECIST v1.1
Tidsramme: up to 2 years
stage II
up to 2 years
ORR as assessed by the investigator or BICR per RECIST v1.1
Tidsramme: up to 2 years
stage II
up to 2 years
DOR as assessed by the investigator or BICR per RECIST v1.1
Tidsramme: up to 2 years
stage II
up to 2 years
DCR as assessed by the investigator or BICR per RECIST v1.1
Tidsramme: up to 2 years
stage II
up to 2 years
Cmax，ss
Tidsramme: up to 2years
Maximum Steady-State Plasma Concentration
up to 2years
AUC0-t
Tidsramme: up to 2years
stage I&II AUC from time 0 to last measurable time
up to 2years
t1/2
Tidsramme: up to 2years
stageI&II Half-life
up to 2years

Samarbejdspartnere og efterforskere

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

Sponsor

Jiangxi Kvvit Pharmaceutical Co., Ltd.

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)

6. juni 2027

Primær færdiggørelse (Anslået)

7. februar 2029

Studieafslutning (Anslået)

8. maj 2029

Datoer for studieregistrering

Først indsendt

5. juni 2026

Først indsendt, der opfyldte QC-kriterier

15. juni 2026

Først opslået (Faktiske)

18. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DN022150-301

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

Kliniske forsøg med Kræft i bugspytkirtlen

Kliniske forsøg med DN022150+AG( Stage I ）

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