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

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: Not yet recruiting
• Conditions: MTAP Deletion
• Intervention / Treatment: Drug: HS-10587

• Study Type: Interventional
• Enrollment (Estimated): 362
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Incidence of DLT	dose-limiting toxicities	Up to 21 days after the first administration. (first cycle)
MTD or MAD	maximum tolerated dose (MTD) or maximum applicable dose (MAD)	Up to 21 days after the first administration. (first cycle)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs) and serious adverse events (SAEs)	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	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 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	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	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	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.	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.	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 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.	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.	Overall survival (OS) evaluated as per RECIST v1.1	Predose and post dose up to end of treatment, approximately 2 years

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 4, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: April 20, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Advanced Solid Tumors
• Other Study ID 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