Testing SHR-7631 in patients with advanced solid tumors
An Open-label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-7631 for Injection in Patients With Advanced Solid Tumors
This study is testing a new drug called SHR-7631 to see if it can safely help people with advanced solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Beijing, Beijing and 1 other locations) |
| Trial ID | NCT06381050 on ClinicalTrials.gov |
What this trial studies
This is an open-label, phase I clinical trial evaluating the safety and efficacy of SHR-7631 in patients with advanced solid tumors. The study is structured into three stages: dose escalation, dose expansion, and efficacy expansion, allowing researchers to determine the optimal dosage and assess the drug's effectiveness. Participants will be closely monitored for responses and side effects throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with unresectable locally advanced or metastatic solid tumors that have relapsed or are refractory to standard treatments.
Not a fit: Patients with active central nervous system metastases or those who have received anti-tumor therapies within four weeks prior to the trial 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 that are resistant to standard therapies.
How similar studies have performed: Other studies have shown promise with similar investigational therapies, but the specific approach of SHR-7631 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently; 2. Have at least one measurable tumor lesion per RECIST v1.1 (subject with only non-target tumor lesion will be permitted if he/she is planned to participant in dose escalation stage or with mCRPC); 3. ECOG performance status of 0-1; 4. Life expectancy ≥ 12 weeks; 5. Adequate bone marrow and organ function 6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form. 7. Age 18 to 75 years old (including both ends), gender is not limited; Exclusion Criteria: 1. Patients with active central nervous system metastases or meningeal metastases; 2. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug; 3. Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors; 4. History of serious cardiovascular and cerebrovascular diseases; 5. Severe infection within 4 weeks prior to the first dose; 6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
Where this trial is running
Beijing, Beijing and 1 other locations
- Peking University Cancer Hospital — Beijing, Beijing, China (Recruiting)
- Sun Yat-sen University Cancer Center — Guangzhou, Guangzhou, China (Recruiting)
Study contacts
- Study coordinator: Xiaoyu Zhu
- Email: zhuxiaoyu@hengrui.com
- Phone: +86 021-61053363
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.