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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • HS-10587

    Drug

    HS-10587 tablet

Treatment groups

362 Participants
are divided into 1 treatment group
Group A: HS-10587 MonotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of DLT

dose-limiting toxicities

Time frame
Up to 21 days after the first administration. (first cycle)
2

MTD or MAD

maximum tolerated dose (MTD) or maximum applicable dose (MAD)

Time frame
Up to 21 days after the first administration. (first cycle)

Secondary outcomes

1

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

Number of participants with AEs and SAEs

Time frame
From time of informed consent to 28 days post last dose of HS-10587.
2

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

Maximum concentration (Cmax).

Time frame
Predose and postdose up to end of treatment, approximately 2 years
3

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

Time of maximum concentration (Tmax).

Time frame
Predose and postdose up to end of treatment, approximately 2 years.
4

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)

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: