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Not yet recruitingNCT07567859Updated May 5, 2026

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

A Phase 1 interventional study of HS-10587 in MTAP Deletion, sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
362
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • MTAP Deletion

Keywords

  • Advanced Solid Tumors
03

In context

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd. is the lead sponsor of 131 studies on the registry; 70 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
362 participants (estimated)

Study arms

  • Experimental
    HS-10587 Monotherapy

    Dose escalation cohorts and dose expansion cohorts of varying doses of HS-10587

    Drug: HS-10587

Interventions

  • DrugHS-10587

    HS-10587 tablet

06

What researchers measure

Primary outcomes

  1. Incidence of DLT

    dose-limiting toxicities

    Time frame: Up to 21 days after the first administration. (first cycle)

  2. MTD or MAD

    maximum tolerated dose (MTD) or maximum applicable dose (MAD)

    Time frame: Up to 21 days after the first administration. (first cycle)

Secondary outcomes

  1. Incidence of adverse events (AEs) and serious adverse events (SAEs)

    Number of participants with AEs and SAEs

    Time frame: From time of informed consent to 28 days post last dose of HS-10587.

  2. Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors

    Maximum concentration (Cmax).

    Time frame: Predose and postdose up to end of treatment, approximately 2 years

  3. Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors

    Time of maximum concentration (Tmax).

    Time frame: Predose and postdose up to end of treatment, approximately 2 years.

  4. Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors

    area under the plasma concentration-time curve from time 0 to time t of the last measurable concentration (AUC0-t)

    Time frame: Predose and postdose up to end of treatment, approximately 2 years.

  5. Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors

    Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)

    Time frame: Predose and postdose up to end of treatment, approximately 2 years

  6. Efficacy of HS-10587 in patients with advanced solid tumors

    Objective response rate (ORR) evaluated as per RECIST v1.1

    Time frame: Predose and post dose up to end of treatment, approximately 2 years

  7. Efficacy of HS-10587 in patients with advanced solid tumors.

    Duration of response (DOR) evaluated as per RECIST v1.1

    Time frame: Predose and post dose up to end of treatment, approximately 2 years.

  8. Efficacy of HS-10587 in patients with advanced solid tumors.

    Disease control rate (DCR) evaluated as per RECIST v1.1

    Time frame: Predose and post dose up to end of treatment, approximately 2 years

  9. Efficacy of HS-10587 in patients with advanced solid tumors.

    Time to response (TTR) evaluated as per RECIST v1.1

    Time frame: Predose and post dose up to end of treatment, approximately 2 years.

  10. Efficacy of HS-10587 in patients with advanced solid tumors.

    Progression-free survival (PFS) evaluated as per RECIST v1.1

    Time frame: Predose and post dose up to end of treatment, approximately 2 years.

  11. Efficacy of HS-10587 in patients with advanced solid tumors.

    Overall survival (OS) evaluated as per RECIST v1.1

    Time frame: Predose and post dose up to end of treatment, approximately 2 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07567859
Lead sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
May 5, 2026
Start date
Jun 4, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
May 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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