Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • HRS-8364 Tablet

    Drug

    HRS-8364 tablet.

Treatment groups

282 Participants
are divided into 1 treatment group
Group A: HRS-8364 GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The Dose-Limiting Toxicity (DLT)

Time frame
Post-dose at Day 1 to Day 21.
2

The Maximum Tolerated Dose (MTD)

Time frame
Post-dose at Day 1 to the end of treatment visit, about 1 year.
3

Recommended dosage for Phase II (RP2D)

Time frame
Post-dose at Day 1 to the end of treatment visit, about 1 year.
4

Incidence and severity of adverse events (AEs)

Time frame
From signing the informed consent form to safety follow-up completed, about 1 year.

Secondary outcomes

1

Maximum Concentration of HRS-8364 (Cmax)

Time frame
Day 1 pre-dose to the end of treatment visit, about 1 year.
2

Time to maximum plasma concentration (Tmax)

Time frame
Day 1 pre-dose to the end of treatment visit, about 1 year.
3

Area under the concentration versus time curve of HRS-8364 from time zero to time t (AUC0-t).

Time frame
Day 1 pre-dose to the end of treatment visit, about 1 year.
4

Bioaccumulation of HRS-8364 in postprandial relative fasting state.

Time frame
Cycle 0 Day1 pre-dose to Cycle 1 Day 3, about 6 days.

Other outcomes

Sponsors and contacts

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

Jiangsu HengRui Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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