HRS-8364 treatment for advanced solid tumors

An Open Label, Multicenter Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-8364 in the Treatment of Advanced Solid Tumor Subjects

This will test HRS-8364 tablets to see if they help adults aged 18–75 with advanced solid tumors who have not responded to or cannot tolerate standard treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 282 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT07446153 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase 1/2 trial gives oral HRS-8364 in three stages: dose escalation to find a safe dose, dose expansion to further characterize tolerability, and efficacy expansion to look for antitumor activity. Participants receive HRS-8364 tablets as monotherapy, with expansion cohorts that may include patients without prior immune checkpoint inhibitor exposure. The trial enrolls adults with histologically or cytologically confirmed advanced solid tumors who have progressed on or are intolerant of standard therapies. Conducted at hospitals in China, the study will monitor safety, pharmacology, and preliminary efficacy endpoints such as response and progression.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 with histologically or cytologically confirmed advanced solid tumors who have progressed on or cannot tolerate standard treatments.

Not a fit: Patients with early-stage disease, those well controlled on available standard therapies, or those unable to attend study visits at the trial sites are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, HRS-8364 could provide a new oral treatment option that slows tumor growth or shrinks tumors in patients with advanced solid cancers who have few or no other options.

How similar studies have performed: Other early-phase programs of novel oral anticancer agents have produced tumor responses in specific cancers, but HRS-8364 itself is an investigational agent without established clinical efficacy yet.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily joining this study, signing an informed consent form, good compliance, and able to cooperate with follow-up.
2. Age range: 18-75 years old (including boundary values), both males and females are eligible.
3. 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.
4. 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).
5. Efficacy expansion of monotherapy: advanced solid tumors diagnosed by histopathology or cytology; with other systemic treatments during the recurrence or metastasis stage, and disease progression during or after treatment.
6. At least one measurable lesion that meets the RECIST v1.1 criteria.
7. ECOG PS score: 0 to 1.
8. Expected survival ≥ 12 weeks.
9. Female subjects with reproductive ability and male subjects with partners who are reproductive women must agree to use efficient contraception during the trial period and within 30 days after the last dose of HRS-8364 (whichever comes later), have no fertility plan, and avoid donating eggs/sperm; Female subjects with fertility must have a negative blood pregnancy test within 7 days prior to the first administration and must be non-lactating.

Exclusion Criteria:

1. Untreated brain metastases; Or accompanied by meningeal metastasis, spinal cord compression, etc.
2. 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.
3. Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion accompanied by clinical symptoms.
4. 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.
5. Other malignant tumors in the past 5 years or at the same time.
6. Major arterial/venous thrombotic events within 6 months prior to the first use of medication, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction (excluding asymptomatic lacunar cerebral infarction)), deep vein thrombosis (excluding asymptomatic and non anticoagulant intramuscular vein thrombosis), and pulmonary embolism.
7. Past or current active interstitial lung disease requiring treatment, non-infectious pneumonia requiring glucocorticoid systemic therapy (such as radiation pneumonitis); Currently, individuals with active pneumonia or confirmed severe pulmonary ventilation dysfunction through lung function tests.
8. Individuals with active pulmonary tuberculosis. Individuals who have undergone sufficient treatment and have stopped anti tuberculosis treatment for at least 3 months prior to their first medication can be enrolled in the study.
9. Known to have a positive history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). Known to have active viral hepatitis.
10. Unable to swallow pills normally or experiencing gastrointestinal dysfunction, which may affect drug absorption according to researchers' assessment.
11. Individuals who have experienced intestinal obstruction or gastrointestinal perforation within 3 months prior to their first medication use.
12. According to the researchers' assessment, there are other factors that may affect the research results or lead to the forced termination of this study, such as alcohol abuse, drug use, drug abuse, other serious illnesses (including mental illnesses) that require concurrent treatment, serious laboratory test abnormalities, and family or social factors that may affect medication safety.

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• The Sixth Affiliated Hospital, Sun-Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)
• Liaoning Cancer Hospital & Institute — Shenyang, Liaoning, China (Recruiting)

Study contacts

• Study coordinator: Cong Wen

Conditions Solid Tumor