A Clinical Study of HRS-8364 in the Treatment of Advanced Solid Tumor Subjects
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.
About this trial
This study is an open, multicenter, Phase I/II clinical trial, divided into three stages: dose escalation, dose expansion and efficacy expansion.
Eligibility criteria
Qualifiers
Voluntarily joining this study, signing an informed consent form, good compliance, and able to cooperate with follow-up.
Age range: 18-75 years old (including boundary values), both males and females are eligible.
Monotherapy dose escalation stage: advanced solid tumors diagnosed by cytology or histology, which have failed standard treatment or are intolerant to previous standard treatment or have no standard treatment.
Monotherapy dose expansion stage: advanced solid tumors diagnosed by cytology or histology; with other systemic treatments during the recurrence or metastasis stage, and disease progression during or after treatment; The combined dose expansion phase allows for the inclusion of individuals who have not received prior treatment with immuno checkpoint inhibitors (ICIs).
Disqualifiers
Untreated brain metastases; Or accompanied by meningeal metastasis, spinal cord compression, etc.
Large blood vessels invasion confirmed by imaging, or the subject's tumor has a high possibility of invading important blood vessels and causing fatal bleeding during treatment judged by researchers.
Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion accompanied by clinical symptoms.
Severe bone damage caused by tumor bone metastasis, including uncontrolled severe bone pain, pathological fractures in important areas that have occurred or are expected to occur in the past 6 months, and spinal cord compression. Subjects who require analgesic medication must have a stable analgesic treatment plan in place at the time of entry into the study.
Trial design
Treatments tested in this trial
- HRS-8364 Tablet
Treatment groups
282 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov