Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Study of HS-10587 in Patients With Advanced Solid Tumors

28. april 2026 opdateret af: Jiangsu Hansoh Pharmaceutical Co., Ltd.

An Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics, and Preliminary Efficacy of HS-10587 in Patients With Methylthioadenosine Phosphorylase (MTAP)-Deleted Advanced Solid Tumors

This is a Phase I, multicenter, open-label clinical trial with dose escalation/dose expansion phases, designed to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD) profiles, and antitumor efficacy characteristics of HS-10587 in patients with MTAP-deleted advanced solid tumors.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

362

Fase

  • Fase 1

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. Participants who voluntarily participate in this clinical study, understand the study procedures, and are able to sign a written ICF.
  2. Participants with locally advanced or recurrent metastatic malignant solid tumors confirmed by histopathology or cytopathology who have failed or are intolerant to at least one line of prior standard treatment, or for whom no standard treatment exists.
  3. Evidence of MTAP deletion in the tumor tissue.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  5. Life expectancy ≥12 weeks.
  6. At least one measurable lesion that would qualify as target lesion by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
  7. Female participants of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed; male participants are willing to use barrier contraception.

Exclusion Criteria:

  1. History of other primary malignancies.
  2. Presence of pleural/abdominal effusion or pericardial effusion requiring clinical intervention.
  3. Presence of leptomeningeal metastasis, spinal cord compression, or brainstem metastasis; known untreated brain metastases, or symptomatic/unstable brain metastases.
  4. Participants who have any Grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 6.0) from prior anti-tumor therapies (except alopecia, pigmentation, and residual neurotoxicity).
  5. Inadequate bone marrow reserve or hepatic and renal functions.
  6. Severe, uncontrolled, or active cardiovascular diseases.
  7. Severe or poorly controlled diabetes.
  8. Severe or poorly controlled hypertension.
  9. Severe infection within 4 weeks prior to the first dose.
  10. Long-term corticosteroid therapy, history of other acquired/congenital immunodeficiency disorders, or organ transplantation.
  11. Known active infectious diseases.
  12. Clinically significant gastrointestinal dysfunction.
  13. Moderate to severe pulmonary diseases that seriously affect respiratory function.
  14. Prior history of severe neurological or mental disorders.
  15. Female participants who are pregnant or breastfeeding, or plan to become pregnant during the study.
  16. History of severe allergies, or history of hypersensitivity reactions to any active or inactive ingredients of HS-10587 or to drugs with similar chemical structures to HS-10587 or drugs of the same class as HS-10587.
  17. Participants with any conditions that may jeopardize participant safety or interfere with study assessments, as 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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: HS-10587 Monotherapy
Dose escalation cohorts and dose expansion cohorts of varying doses of HS-10587
HS-10587 tablet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of DLT
Tidsramme: Up to 21 days after the first administration. (first cycle)
dose-limiting toxicities
Up to 21 days after the first administration. (first cycle)
MTD or MAD
Tidsramme: Up to 21 days after the first administration. (first cycle)
maximum tolerated dose (MTD) or maximum applicable dose (MAD)
Up to 21 days after the first administration. (first cycle)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Tidsramme: From time of informed consent to 28 days post last dose of HS-10587.
Number of participants with AEs and SAEs
From time of informed consent to 28 days post last dose of HS-10587.
Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors
Tidsramme: Predose and postdose up to end of treatment, approximately 2 years
Maximum concentration (Cmax).
Predose and postdose up to end of treatment, approximately 2 years
Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors
Tidsramme: Predose and postdose up to end of treatment, approximately 2 years.
Time of maximum concentration (Tmax).
Predose and postdose up to end of treatment, approximately 2 years.
Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors
Tidsramme: Predose and postdose up to end of treatment, approximately 2 years.
area under the plasma concentration-time curve from time 0 to time t of the last measurable concentration (AUC0-t)
Predose and postdose up to end of treatment, approximately 2 years.
Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors
Tidsramme: Predose and postdose up to end of treatment, approximately 2 years
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)
Predose and postdose up to end of treatment, approximately 2 years
Efficacy of HS-10587 in patients with advanced solid tumors
Tidsramme: Predose and post dose up to end of treatment, approximately 2 years
Objective response rate (ORR) evaluated as per RECIST v1.1
Predose and post dose up to end of treatment, approximately 2 years
Efficacy of HS-10587 in patients with advanced solid tumors.
Tidsramme: Predose and post dose up to end of treatment, approximately 2 years.
Duration of response (DOR) evaluated as per RECIST v1.1
Predose and post dose up to end of treatment, approximately 2 years.
Efficacy of HS-10587 in patients with advanced solid tumors.
Tidsramme: Predose and post dose up to end of treatment, approximately 2 years
Disease control rate (DCR) evaluated as per RECIST v1.1
Predose and post dose up to end of treatment, approximately 2 years
Efficacy of HS-10587 in patients with advanced solid tumors.
Tidsramme: Predose and post dose up to end of treatment, approximately 2 years.
Time to response (TTR) evaluated as per RECIST v1.1
Predose and post dose up to end of treatment, approximately 2 years.
Efficacy of HS-10587 in patients with advanced solid tumors.
Tidsramme: Predose and post dose up to end of treatment, approximately 2 years.
Progression-free survival (PFS) evaluated as per RECIST v1.1
Predose and post dose up to end of treatment, approximately 2 years.
Efficacy of HS-10587 in patients with advanced solid tumors.
Tidsramme: Predose and post dose up to end of treatment, approximately 2 years
Overall survival (OS) evaluated as per RECIST v1.1
Predose and post dose up to end of treatment, approximately 2 years

Samarbejdspartnere og efterforskere

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

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)

4. juni 2026

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

30. juni 2028

Datoer for studieregistrering

Først indsendt

20. april 2026

Først indsendt, der opfyldte QC-kriterier

28. april 2026

Først opslået (Faktiske)

5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • HS-10587-101

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 MTAP -sletning

Kliniske forsøg med HS-10587

Abonner