Not Yet RecruitingPhase 1

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

362 participantsStarted 2026-06-04

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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.

What they're measuring

Incidence of DLT

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

MTD or MAD

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

Trial details

NCT IDNCT07567859

SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More MTAP Deletion trials