A Phase I/II of HRS-6719 in Patients With Advanced/Metastatic Solid Tumors

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShandong Suncadia Medicine Co., Ltd.

About this trial

This is a Phase I/II, multicenter, open-label clinical trial with dose escalation/dose expansion/efficacy expansion phases, designed to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD) profiles, and antitumor efficacy characteristics of HRS-6719 in patients with MTAP-deficient advanced solid tumors.

Eligibility criteria

Qualifiers

Subjects must voluntarily participate in the study and sign an informed consent form;

Aged 18-75 years, male or female eligible;

ECOG performance status score of 0-1;

Expected survival ≥12 weeks;

Disqualifiers

History of other malignant tumors within the past 5 years;

Received systemic anti-tumor therapy within 4 weeks prior to the first study dose.

Surgical procedures requiring tracheal intubation and general anesthesia were performed within 4 weeks before the first administration, diagnostic or surface surgery was performed within 1 week before the first administration, or elective surgery was expected during the trial.

The study received radical radiotherapy within 4 weeks before the first medication ; and received palliative radiotherapy within 2 weeks before the first medication.

Trial design

Treatments tested in this trial

  • HRS-6719

Treatment groups

120 Participants
are divided into 1 treatment group