A Study of HS-10587 in Patients With Advanced Solid Tumors
ConditionMTAP Deletion
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- HS-10587
Treatment groups
362 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov