A Study of HS-10587 in Patients With Advanced Solid Tumors
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
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Fase 1
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Participants who voluntarily participate in this clinical study, understand the study procedures, and are able to sign a written ICF.
- 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.
- Evidence of MTAP deletion in the tumor tissue.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥12 weeks.
- At least one measurable lesion that would qualify as target lesion by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
- 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:
- History of other primary malignancies.
- Presence of pleural/abdominal effusion or pericardial effusion requiring clinical intervention.
- Presence of leptomeningeal metastasis, spinal cord compression, or brainstem metastasis; known untreated brain metastases, or symptomatic/unstable brain metastases.
- 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).
- Inadequate bone marrow reserve or hepatic and renal functions.
- Severe, uncontrolled, or active cardiovascular diseases.
- Severe or poorly controlled diabetes.
- Severe or poorly controlled hypertension.
- Severe infection within 4 weeks prior to the first dose.
- Long-term corticosteroid therapy, history of other acquired/congenital immunodeficiency disorders, or organ transplantation.
- Known active infectious diseases.
- Clinically significant gastrointestinal dysfunction.
- Moderate to severe pulmonary diseases that seriously affect respiratory function.
- Prior history of severe neurological or mental disorders.
- Female participants who are pregnant or breastfeeding, or plan to become pregnant during the study.
- 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.
- Participants with any conditions that may jeopardize participant safety or interfere with study assessments, as judged by the investigator.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / 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
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
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
Sponsor
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- HS-10587-101
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
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