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

NCT07567859 | Not Yet Recruiting Phase 1

• 1 other identifier: HS-10587-101
• Study Type: interventional
• Target: 362
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

MTAP Deletion

Keywords

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Incidence of adverse events (AEs) and serious adverse events (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

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

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

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

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

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

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

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

Study Arms (1)

HS-10587 Monotherapy

EXPERIMENTAL

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

Drug: HS-10587

Interventions

HS-10587 DRUG

HS-10587 tablet

HS-10587 Monotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 5, 2026
• Study Start (Estimated): June 4, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04