Testing SHR-7367 for advanced solid tumors
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of SHR-7367 in Subjects With Advanced Solid Tumors
PHASE1 · Shanghai Hengrui Pharmaceutical Co., Ltd. · NCT05740202
This study is testing a new treatment called SHR-7367 to see if it is safe and effective for people with advanced solid tumors.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 182 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Hengrui Pharmaceutical Co., Ltd. (industry) |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT05740202 on ClinicalTrials.gov |
What this trial studies
This Phase 1 trial evaluates the safety and tolerability of SHR-7367 in patients with advanced solid tumors. It involves a dose-escalation and dose-expansion approach to determine the appropriate dosage and monitor any adverse effects. Participants will be closely monitored for their response to the treatment and any side effects experienced during the trial. The study aims to gather preliminary data on the efficacy of SHR-7367 in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with documented advanced or metastatic solid tumors and a good performance status.
Not a fit: Patients with recent immunotherapy or systemic anti-tumor therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.
How similar studies have performed: While this approach is part of ongoing research, the specific compound SHR-7367 has not been previously tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study; 2. Male or female aged ≥18 years and ≤75 years at the time of signing the ICF; 3. Histopathologically or cytologically documented advanced or metastatic malignancies; 4. At least 1 measurable lesion conforming to RECIST 1.1 criteria; 5. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; 6. Female and male patients of reproductive potential must agree to use highly effective contraception. Exclusion Criteria: 1. Any immunostimulants administered within 4 weeks; 2. Systemic anti-tumor therapy within 4 weeks; 3. Any investigational cancer therapy administered within 4 weeks; 4. Surgical procedures requiring general anesthesia within 4 weeks; 5. History of autoimmune diseases; 6. History of immunodeficiency; 7. Severe infections within 2 weeks prior to the first study treatment; 8. Clinically significant cardiovascular condition; 9. Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment; 10. Known history of serious allergic reactions to the investigational product or its main ingredients.
Where this trial is running
Tianjin, Tianjin
- Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin, China (RECRUITING)
Study contacts
- Study coordinator: Junshuang diao
- Email: junshuang.diao@hrglobe.cn
- Phone: +0518-82342973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Solid Tumors