Evaluating SHR-1681 for patients with advanced solid tumors
A Phase I/II, Multicenter, Open-Label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-1681 for Injection in Patients With Malignant Solid Tumors
This study is testing a new injection called SHR-1681 to see if it can safely help people with advanced solid tumors that haven't responded to other treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06737731 on ClinicalTrials.gov |
What this trial studies
This is an open-label, multicenter Phase I/II clinical trial designed to assess the safety, tolerability, pharmacokinetics, and efficacy of SHR-1681 for injection in patients suffering from advanced solid tumors. The study will enroll participants with unresectable locally advanced or metastatic solid tumors that have either relapsed, are refractory to standard treatments, or for which no standard treatment is applicable. Participants will be monitored for measurable tumor lesions and must meet specific health criteria to ensure their eligibility.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors that are relapsed or refractory to standard treatment.
Not a fit: Patients with active central nervous system metastases, serious cardiovascular or cerebrovascular diseases, or those who have had recent anti-tumor therapies 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 who have limited treatment alternatives.
How similar studies have performed: While this specific approach is novel, similar studies evaluating new treatments for advanced solid tumors have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form; 2. Subjects 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; 3. Have at least one measurable tumor lesion per RECIST v1.1; 4. ECOG performance score of 0-1; 5. Life expectancy ≥ 3 months; 6. Adequate bone marrow and organ function. Exclusion Criteria: 1. Subjects with active central nervous system metastases or meningeal metastases; 2. History of serious cardiovascular and cerebrovascular diseases; 3. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; 4. Severe infection within 4 weeks prior to the first dose; 5. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug; 6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Dongfang Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Fei Qiu
- Email: fei.qiu@hengrui.com
- Phone: +86-0518-82342973
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.