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

28 april 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

362

Fase

  • Fase 1

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: HS-10587 Monotherapy
Dose escalation cohorts and dose expansion cohorts of varying doses of HS-10587
HS-10587 tablet

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of DLT
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

4 juni 2026

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

30 juni 2028

Studieregistratiedata

Eerst ingediend

20 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 april 2026

Eerst geplaatst (Werkelijk)

5 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

28 april 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • HS-10587-101

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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