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

April 28, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
362

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HS-10587 Monotherapy
Dose escalation cohorts and dose expansion cohorts of varying doses of HS-10587
Drug: HS-10587
HS-10587 tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of DLT
Time Frame: 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
Time Frame: 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)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 4, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS-10587-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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