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A Study of DAT-2645 in Patients With BRCA1/2 Mutations or HRD-Positive Ovarian Cancer

21. juni 2026 opdateret af: Danatlas Pharmaceuticals Co., Ltd

A Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of DAT-2645 in Patients With BRCA1/2 Deleterious Mutations or HRD-Positive Advanced/Metastatic Ovarian Cancer

This is a Phase II, multicenter, single-arm dose expansion trial planned to enroll up to 30 subjects with advanced or metastatic ovarian cancer. The Objective is to conduct a preliminary evaluation of the efficacy, the safety, tolerability and PK profile of DAT-2645

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is a multicenter, dose expansion, single-arm Phase II clinical trial. Administered once daily in the morning on an empty stomach at the recommended dose (RDE). Each treatment cycle consists of 21 days, with continuous administration until the first occurrence of disease progression, intolerable toxicity, withdrawal from the study, loss to follow-up, or initiation of new anticancer therapy. The trial plans to enroll 30 participants with advanced or metastatic ovarian cancer. The sponsor or investigator may terminate patient enrollment early based on interim efficacy and safety data.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

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

  • Kina
      • Beijing, Kina, 100021
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510050
        • Research Site

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:

  • sign a written informed consent form
  • At least 18 years of age (inclusive)
  • Epithelial ovarian cancer confirmed by histopathology or cytopathology
  • BRCA1/2 mutation or HRD-positive status
  • Patients who have failed standard treatment or are unable to tolerate standard treatment
  • Patients must have received no more than five prior treatment lines
  • At least one measurable lesion
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Bone marrow reserve and organ function must meet the requirements
  • Negative result on a blood pregnancy test for a woman of childbearing age

Exclusion Criteria:

  • Received small-molecule chemotherapy or targeted therapy within 2 weeks or 5 half-lives prior to the first dose
  • Received treatment with an anticancer biological therapy within 4 weeks prior to the first dose
  • Underwent major surgery within 4 weeks prior to the first dose
  • Has previously received treatment with a PARG inhibitor
  • Inadequate response to previous PARP inhibitor maintenance therapy
  • With central nervous system metastases
  • Patients with clinically significant cardiovascular or cerebrovascular diseases
  • Uncontrolled active infections requiring intravenous antibiotics or hospitalization
  • Adverse reactions from prior anticancer therapy have not yet resolved to a grade ≤1

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: DAT-2645 tablet
Monotherapy under the recommended dose (RDE)
Medicin: DAT-2645 tablet
Oral administration with 21 days each cycle

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective response rate ( ORR )
Tidsramme: Approximately 2 years
Objective response rate (ORR) as assessed by investigators according to RECIST v.1.1
Approximately 2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Disease Control Rate (DCR)
Tidsramme: Approximately 2 years
Defined as not meeting the criteria for progression and PR(partial response)
Approximately 2 years
Duration of Response (DOR)
Tidsramme: Approximately 2 years
DOR(duration of response) per RECIST v1.1(Response Evaluation Criteria in Solid Tumors). Measured in CT/MRI image from the time when measurement criteria for complete/ partial response are met till time when progression of the disease is documented.
Approximately 2 years
Progression Free Survival (PFS)
Tidsramme: Approximately 2 years
Progression- free survival (PFS) by RECIST V1.1 criteria- from the beginning of treatment to the progression of disease or death.
Approximately 2 years
Overall Survival (OS)
Tidsramme: Approximately 2 years
Overall Survival (OS) was defined as the time interval between a patient randomized and death from any cause or the end of the last follow-up date.
Approximately 2 years
Adverse events
Tidsramme: Approximately 2 years
The incidence of TEAE, TRAE, SAE, and clinically significant abnormalities (including laboratory tests, vital signs, physical examination, and electrocardiogram).
Approximately 2 years
Area Under the Plasma Concentration Versus Time Curve (AUC) of DAT-2645
Tidsramme: Approximately 2 years
PK parameter: AUC of DAT-2645
Approximately 2 years
Time to Achieve Maximal Plasma Concentration (Tmax) of DAT-2645
Tidsramme: Approximately 2 years
PK parameter: Tmax of DAT-2645
Approximately 2 years
Maximal Plasma Concentration (Cmax) of DAT-2645
Tidsramme: Approximately 2 years
PK parameter: Cmax of DAT-2645
Approximately 2 years

Samarbejdspartnere og efterforskere

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

Sponsor

Danatlas Pharmaceuticals 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)

15. juni 2026

Primær færdiggørelse (Anslået)

30. november 2027

Studieafslutning (Anslået)

30. marts 2028

Datoer for studieregistrering

Først indsendt

11. juni 2026

Først indsendt, der opfyldte QC-kriterier

11. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DAT2645-Clin-201-CN

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 DAT-2645 tablet

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Burkina Faso

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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