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

28 april 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

362

Fas

  • Fas 1

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. 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

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: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of DLT
Tidsram: 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
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

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 (Beräknad)

4 juni 2026

Primärt slutförande (Beräknad)

31 december 2027

Avslutad studie (Beräknad)

30 juni 2028

Studieregistreringsdatum

Först inskickad

20 april 2026

Först inskickad som uppfyllde QC-kriterierna

28 april 2026

Första postat (Faktisk)

5 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 april 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • HS-10587-101

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